Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Part 1 of the study will include escalating doses of KAND567 administered in combination with carboplatin (according to standard of care) to approximately 10 subjects in total (may range from 6 to 24 subjects depending on DLTs). Carboplatin will be given on Day 1 of the 21-day cycle at a dose of AUC 5 according to standard of care. KAND567 will be orally administered during the first 2 weeks (Days 2 to 14) of each 21-day carboplatin cycle for up to 6 treatment cycles (or until unacceptable toxicity or disease progression).

KAND567 dose escalation will apply for the first week (Days 2 to 7) of the treatment cycle. During the second week of the treatment cycle (Days 8 to 14), KAND567 will be administered at a fixed dose of 250 mg BID to all subjects. Doses of KAND567 will be escalated according to an adaptive, intra-individual dose escalation design.

An expansion cohort will be enrolled in Part 2 of the study to further evaluate the RPIID (approximately 20 subjects; may range from 6 to 24 subjects, depending on Part 1). If the number of subjects with confirmed CX3CR1 expression in tumor cells is below 50%, an additional 15 subjects may be included in Part 2 of the study.

Carboplatin will be given on Day 1 of the 21-day cycle at a dose of AUC 5 according to standard of care. For KAND567, the RPIID will be orally administered to the cohort during the first week of each carboplatin cycle (Days 2 to 7). During the second week of the treatment cycle (Days 8 to 14), KAND567 will be administered at 250 mg BID. Up to 6 treatment cycles will be given (or until unacceptable toxicity or disease progression).

KAND567 is a drug in capsule and is intended to be orally administered approximately every 12 hours (±1 hour) with an initial loading dose on Day 2 of two times the dose specified for that dose group (e.g., 2 x 250, 2 x 375, 2 x 500, or 2 x 625 mg KAND567, depending on the dose group; in Part 2, this is the RPIID), followed by a KAND567 dose (Day 2, evening dose) that corresponds to the given dose level. On Days 3 to 7, the subjects will be orally administered the specified KAND567 dose (e.g., 250, 375, 500, or 625 mg BID, depending on the dose group; in Part 2, this is the RPIID).

During the second week of dosing (Days 8 to 14) in Part 1 and Part 2, the subjects will be orally administered KAND567 at a dose of 250 mg BID. One treatment cycle is defined as a 21-day period, and each subject will receive up to 6 treatment cycles (or until unacceptable toxicity or disease progression).

KAND567

Carboplatin will be administered i.v. according to standard of care at a dose of AUC 5. One cycle is defined as a 21-day period with chemotherapy given on Day 1. Each subject will receive up to 6 treatment cycles (or until unacceptable toxicity or disease progression). The carboplatin dose should be calculated using the Calvert formula: Carboplatin dose (mg) = target AUC 5 × (GFR + 25). GFR should be calculated using the Cockcroft-Gault formula. The maximum carboplatin dose is based on a calculated GFR that is capped at 125 mL/min for subjects with normal renal function.

Thomas Olin, PhD

Trine Lembrect Jørgensen, MD/PhD

Kristina Lindemann, MD/PhD

Susanne Malander, MD/PhD

Hanna Dahlstrand, MD/PhD

The study is a multicenter, Phase Ib/IIa, open-label, dose-escalation study to evaluate the safety and tolerability of orally administered KAND567 in combination with carboplatin therapy, and to determine the Recommended Phase II Dose (RPIID) of KAND567 in combination with carboplatin in subjects with recurrent platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

In Part 1, dose escalation will be based on the recommendation of the Safety Review Committee (SRC) after review of the emerging safety and tolerability information. Once the RPIID has been identified in Part 1, the SRC may recommend to the Sponsor to start Part 2.

An expansion cohort will be enrolled in Part 2 of the study to further evaluate the RPIID (approximately 20 subjects; may range from 6 to 24 subjects, depending on Part 1). If the number of subjects with confirmed CX3CR1 expression in tumor cells is below 50%, an additional 15 subjects may be included in Part 2 of the study.

A Study to Evaluate the Safety of KAND567, in Combination With Carboplatin Therapy, in Women With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

KANDOVA - A Two-Part Phase Ib/IIa Study to Evaluate the Safety and Tolerability of KAND567, in Combination With Carboplatin Therapy, and to Determine the Recommended Phase II Dose (RPIID) of KAND567: An Open-Label, Multicenter Dose Escalation Study With an Expansion Cohort in Women With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Measured by occurence of AEs and serious adverse events (SAEs)

Measured by the occurrence of clinically abnormal vital signs

Measured by the occurrence of clinically abnormal electrocardiography (ECG)

Measured by the occurrence of clinically abnormal lab test results (routine clinical chemistry, haematology, and urinalysis)

In Part 1/Phase Ib, RPIID of KAND567 in combination with carboplatin therapy will be determined based on safety and tolerability (DLTs).

Evaluate ORR according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Gynecologic Cancer Intergroup (GCIG) definitions, i.e., best overall response in subjects with measurable disease who are evaluable by CA 125.

Evaluate PFS according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Gynecologic Cancer Intergroup (GCIG) definitions, i.e., the time from start of treatment to disease progression or death.

Evaluate OS according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Gynecologic Cancer Intergroup (GCIG) definitions, i.e., the time from the start of treatment to death due to any cause.

Evaluate DCR, i.e., Complete response (CR) + Partial response (PR) + Stable disease (SD), according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Gynecologic Cancer Intergroup (GCIG) definitions, where: CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameter; and SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

Evaluate duration of response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Gynecologic Cancer Intergroup (GCIG) definitions, i.e., time from documentation of tumor response to disease progression.

Change in pain score (patient reported outcome), as measured by the Numeric Rating Scale (NRS). The NRS is a scale rating pain from "no pain" to "worst pain possible" from 0 to 10, where a higher value indicates greater pain intensity.

Blood samples will be collected for the determination of concentrations of KAND567 in plasma. The determination of the total concentration of KAND567 in plasma will be carried out using Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS). KAND567 PK drug concentration data will be graphically visualized together with normalized PK drug concentration data from the previous KAN0001 study (i.e., no formal PK analysis will be performed).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Evaluate the Safety of KAND567, in Combination With Carboplatin Therapy, in Women With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer	NCT06087289	Epithelial Ovar... Fallopian Tube ... Peritoneal Canc...	KAND567 Carboplatin	18 Years -	Kancera AB
A Study to Evaluate the Safety of KAND567, in Combination With Carboplatin Therapy, in Women With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer	NCT06087289	Epithelial Ovar... Fallopian Tube ... Peritoneal Canc...	KAND567 Carboplatin	18 Years -	Kancera AB

Spots Global Cancer Trial Database for fractalkine

Every month we try and update this database with for fractalkine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fractalkine

Every month we try and update this database with for fractalkine cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fractalkine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.