Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Micronutrients

Hematinics

All Drugs and Chemicals

Antineoplastic Agents

Vitamins

Folic Acid

Mirvetuximab soravtansine

Vitamin B Complex

Maytansine

Immunoconjugates

Immunologic Factors

Tubulin Modulators

Antimitotic Agents

Folinic Acid

Folate

Vitamin B9

Participants will receive mirvetuximab soravtansine intravenous (IV) infusion on Day 1 of every 21-day (every 3 weeks \[Q3W\]) cycle. Dose escalation for this group schedule will start at 0.15 milligrams per kilogram (mg/kg) and proceed through 7.0 mg/kg. Doses calculated initially based on participant's total body weight (TBW); then from protocol amendment 5 onwards, calculated based on adjusted ideal body weight (AIBW). Participants will continue to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever comes first, or until the sponsor terminate the study.

Participants will receive mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation for this group schedule will start at 1.1 mg/kg (calculated based on AIBW) and proceed through 2.5 mg/kg. Participants will continue to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever comes first, or until the sponsor terminate the study.

Participants with epithelial ovarian cancer (EOC) will receive mirvetuximab soravtansine 6.0 mg/kg (maximum tolerated dose \[MTD\]) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants will continue to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever comes first, or until the sponsor terminated the study.

Participants with endometrial cancer (EC) will receive mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants will continue to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever comes first, or until the sponsor terminate the study.

Mirvetuximab soravtansine IV infusion will be administered as per dose and schedule specified in the respective arms.

The purpose of this study is to test mirvetuximab soravtansine (IMGN853) in participants with ovarian cancer and other FOLR-1 positive tumors.

The study consists of a dose-escalation phase that will evaluate 2 dosing schedules (Schedule A and Schedule B) of mirvetuximab soravtansine and up to 5 dose-expansion groups at the maximum tolerated dose (MTD). The first 4 escalation cohorts will be single participant cohorts. Subsequent escalation cohorts will use a standard 3+3 design, with each cohort consisting of 3 or 4 to 6 participants. Data were collected and analysed for the escalation and expansion groups by dose schedule and not by individual dose.

First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors

A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMGN853 in Adults With Ovarian Cancer and Other FOLR1-Positive Solid Tumors

MTD was defined as the highest dose at which 1 or fewer among 6 participants or less than or equal to (\<=) 33 percent (%) experienced a dose-limiting toxicity (DLT) (calculated based on adjusted ideal body weight \[AIBW\]). AIBW was calculated as ideal body weight (IBW) + 0.4 \* (actual weight - IBW), where IBW for men was 0.9 \* height in centimeters (cm) - 88 and IBW for women was 0.9 \* height in cm - 92. DLT was defined as a treatment-emergent adverse event (TEAE) or abnormal laboratory value related to study treatment (that is, assessed as unrelated to disease, intercurrent illness, or concomitant medications), including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment.

RP2D was determined by MTD. MTD was defined as the highest dose at which 1 or fewer among 6 participants or \<=33% experienced a DLT. DLT was defined as a TEAE or abnormal laboratory value related to study treatment (that is, assessed as unrelated to disease, intercurrent illness, or concomitant medications), including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment. Available clinical data indicated that the MTD defined for the Q3W schedule was equal to the RP2D.

An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 on following scale: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any AE that emerged on or after the first dose, and within 28 days of the last dose.

Laboratory parameters included serum chemistry (alanine aminotransferase \[ALT\]/serum glutamic pyruvic transaminase \[SGPT\], aspartate aminotransferase \[AST\]/serum glutamic oxaloacetic transaminase \[SGOT\], albumin, alkaline phosphatase, bilirubin, calcium, creatinine, glucose, magnesium, phosphorous, potassium, sodium), hematology (hemoglobin, lymphocytes, neutrophils, platelets, white blood cells) and coagulation (international normalized ratio \[INR\], partial thromboplastin time \[PTT\]). Clinically significant laboratory values were defined as per NCI CTCAE v.03 Grade 3 or higher. A grading (severity) scale was provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Only participants who shifted from a baseline value of Grade \<=2 to a post-baseline Grade 3/4 on-treatment, are reported.

Physical examination included assessments of general appearance, skin, head (eyes, ears, nose, and throat), neck, lungs, heart, abdomen, back, lymph nodes, extremities, and neurological system. Vital signs included assessment of blood pressure, pulse rate, respiratory rate and body temperature.

Standard ECGs were performed in triplicate at 2- to 5-minute intervals during the study. A single ECG was performed at the end of treatment visit and as clinically indicated.

Ocular AEs included keratopathy and blurred vision. An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. TEAEs were defined as any AE that emerged on or after the first dose, and within 28 days of the last dose.

Pharmacokinetic (PK) parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.

PK parameters were calculated using standard non-compartmental methods. PK analysis of free N2'-\[4-\[(3-carboxypropyl)dithio\]-4-methyl-1-oxo-2-sulfopentyl\]-N2'-deacetylmaytansine (DM4) and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.

PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.

PK parameters were calculated using standard non-compartmental methods. PK analysis of free DM4 and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.

PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, total M9346A antibody, DM4, and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.

PK parameters were calculated using standard non-compartmental methods. PK analysis of DM4 and S-methyl DM4 is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.

PK parameters were calculated using standard non-compartmental methods. PK analysis of mirvetuximab soravtansine, free DM4, S-methyl DM4, and total M9346A antibody is presented for a subgroup of participants who received 6.0 mg/kg (RP2D) mirvetuximab soravtansine at Cycle 1 and Cycle 3.

ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR: At least 30 percent (%) decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.

DOR was defined as the time from the date of the first response (CR or PR), whichever was recorded first, until the date of progressive disease (PD). PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. DOR was only defined for participants who had a BOR of CR or PR using the method of Kaplan-Meier.

PFS was defined as the time from initiation of study drug until PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

TTP was defined as the time from initiation of study drug until PD, estimated using the method of Kaplan-Meier. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

During the conduct of the study, a single immunogenicity assay was developed to concurrently detect human antibodies against all components of mirvetuximab soravtansine, including the humanized anti-FOLR1 antibody, the cleavable disulfide linker, and the cytotoxic maytansinoid, DM4. Therefore, immunogenicity results were reported as ADA titers, and did not distinguish between human anti-drug or anti-human titers.

CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The date of response corresponded to the date when the CA 125 level was first reduced by 50%.

ImmunoGen, Inc.

Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data was only collected and reported by combined groups for the dose-escalation phase and not by individual doses.

Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)

Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)

Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)

Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)

Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)

Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)

Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)

Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)

Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)

Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)

Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)

Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)

Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)

Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)

Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)

Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Safety population included all participants who were enrolled and received at least 1 dose of study drug.

CMO, ImmunoGen

Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule A (Mirvetuximab Soravtansine Q3W)

Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Escalation: Schedule B (Mirvetuximab Soravtansine Weekly)

Dose-Escalation Phase: Maximum Tolerated Dose (MTD) of Mirvetuximab Soravtansine

Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of Mirvetuximab Soravtansine

Any TEAE

SAEs

Grade >=3 TEAEs

Number of Participants With TEAEs

Glucose: Grade 0 to Grade 3

Magnesium: Grade 2 to Grade 3

PTT: Grade 2 to Grade 3

Lymphocytes: Grade 0 to Grade 3

Lymphocytes: Grade 2 to Grade 3

Number of Participants With Shift From Baseline Grade <=2 in Clinical Laboratory Parameters to Grade 3 or Grade 4 on Study

Number of Participants With Clinically Significant Abnormalities in Physical Examination Findings and Vital Signs

Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)

Number of Participants With Treatment-Emergent Ocular AEs

Mirvetuximab soravtansine at Cycle 1

Mirvetuximab soravtansine at Cycle 3

Total M9346A antibody at Cycle 1

Total M9346A antibody at Cycle 3

Participants received mirvetuximab soravtansine 6.0 mg/kg (calculated based on AIBW) on Day 1 of Cycle 1 and Cycle 3.

Mirvetuximab Soravtansine 6.0 mg/kg AIBW

PK Population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable PK data. 'Overall number of participants analyzed' = participants who received mirvetuximab soravtansine at 6 mg/kg AIBW. 'Number analyzed' = participants evaluable for this outcome for specified categories.

Maximum Observed Plasma Concentration (Cmax) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D

DM4 at Cycle 1

DM4 at Cycle 3

S-methyl DM4 at Cycle 1

S-methyl DM4 at Cycle 3

Cmax of Free DM4 and S-Methyl DM4 at RP2D

Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D

AUC0-inf of Free DM4 and S-Methyl DM4 at RP2D

Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D

AUClast of Free DM4 and S-Methyl DM4 at RP2D

Terminal Half-Life (t1/2) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-Methyl DM4 at RP2D

Clearance (CL) of Mirvetuximab Soravtansine and Total M9346A Antibody at RP2D

CL of DM4 and S-Methyl DM4 at RP2D

Time to Reach Maximum Observed Concentration (Tmax) of Mirvetuximab Soravtansine, Free DM4, S-Methyl DM4, and Total M9346A Antibody at RP2D

Volume of Distribution at Steady State (Vss) of Mirvetuximab Soravtansine Free DM4, S-Methyl DM4, and Total M9346A Antibody at RP2D

Participants received mirvetuximab soravtansine IV infusion on Day 1 of every 21-day (Q3W) cycle. Dose escalation started at 0.15 mg/kg and proceeded through 7.0 mg/kg. Doses calculated initially based on participant's TBW; then from protocol amendment 5 onwards, calculated based on AIBW. The doses evaluated during dose escalation for Schedule A, TBW were: 0.15 mg/kg (n=2); 0.5 mg/kg; 1.0 mg/kg, and 2.0 mg/kg (n=1, in each); 3.3 mg/kg (n=9); 5.0 mg/kg (n=11); and 7.0 mg/kg (n=5). The doses evaluated during dose escalation for Schedule A, AIBW were: 5.0 mg/kg (n=7); and 6 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Participants received mirvetuximab soravtansine IV infusion on Days 1, 8, and 15 of every 28-day cycle. Dose escalation started at 1.1 mg/kg and proceeded through 2.5 mg/kg (calculated based on AIBW). The doses evaluated during dose escalation for Schedule B, AIBW were: 1.1 mg/kg (n=5); 1.8 mg/kg (n=4), 2.0 mg/kg (n=9); and 2.5 mg/kg (n=7). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Participants with EOC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Expansion:EOC Participants(Mirvetuximab Soravtansine Q3W)

Participants with EC received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle (calculated based on AIBW). Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Dose Expansion: EC Participants(Mirvetuximab Soravtansine Q3W)

Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. Data was only collected and reported combined for dose-escalation phase and not by individual doses.

Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Efficacy-evaluable population included participants who had radiographic assessment at baseline, received at least 1 dose of study drug, and had at least 1 post-dose tumor assessment or died or clinically progressed within 105 days of last dose. 'Overall number of participants analyzed'=participants who had a BOR of CR or PR. Data by group only.

Duration of Response (DOR) as Assessed by RECIST v1.1

Progression-Free Survival (PFS) as Assessed by RECIST v1.1

Time to Progression (TTP) as Assessed by RECIST v1.1

Immunogenicity population included all participants who received at least 1 infusion of mirvetuximab soravtansine and had evaluable immunogenicity data.

Number of Participants With Anti-Drug Antibodies (ADA)

CA-125 evaluable population included participants who had a baseline CA-125 value greater than or equal to (\>=) 2 \* upper limit of normal (ULN), received at least 1 dose of study drug, and had at least 1 post-dose CA-125 assessment.

Number of Participants With Gynecologic Cancer Intergroup (GCIG) CA-125 Criteria Clinical Responses

Participants received mirvetuximab soravtansine 0.15 milligrams (mg)/kilogram (kg) intravenous (IV) infusion on Day 1 of every 21-day (every 3 weeks \[Q3W\]) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (maximum tolerated dose \[MTD\]) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Participants with folate receptor 1 (FOLR1)-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

Spots Global Cancer Trial Database for First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

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Locations

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