Antineoplastic Agents

All Drugs and Chemicals

Farletuzumab

MORAb-003 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose

MORAb-003

Chifumi Kitamura

MORAb-003 is intravenously administered to Japanese patients with folate receptor-alpha expressing solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose.

A Study of MORAb-003 in Patients With Solid Tumor

A Phase 1 Study of MORAb-003 in Patients With Solid Tumor

Eisai Co., Ltd.

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Fallopian Tube 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

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Micronutrients

Hematinics

Vitamins

Antibodies

Folic Acid

Immunoglobulins

Mirvetuximab soravtansine

Vitamin B Complex

Maytansine

Immunoconjugates

Immunologic Factors

Tubulin Modulators

Antimitotic Agents

Folinic Acid

Folate

Vitamin B9

All patients will receive single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg adjusted ideal body weight (AIBW) administered on Day 1 of every 3-week cycle (Q3W).

Mirvetuximab Soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα mAb M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.

Mirvetuximab Soravtansine

Michael Method, MPH, MBA

Ursula Matulonis, MD

Robert Coleman, MD

This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in patients with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor-Alpha (FRα). Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. All patients will receive single-agent MIRV at 6 mg/kg adjusted ideal body weight administered on Day 1 of every 3-week cycle.

This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in patients with platinum-resistant high-grade serous epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate Receptor Alpha (FRα). Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. FRα positivity will be defined by the Ventana FOLR1 (Folate Receptor 1/Folate Receptor Alpha) Assay.

Approximately 110 eligible patients will be enrolled to achieve a total of 105 efficacy evaluable patients. Efficacy evaluable patients include those who have measurable lesions per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) at baseline and received at least 1 dose of MIRV.

All patients will receive single-agent MIRV at 6 mg/kg adjusted ideal body weight (AIBW) administered on Day 1 of every 3-week cycle (Q3W).

Tumor response will be evaluated by the Investigator using RECIST v1.1. Computerized tomography (CT) or magnetic resonance imaging (MRI) scans will be collected for sensitivity analysis by blinded independent central review (BICR).

Patients will continue to receive MIRV until disease progression, unacceptable toxicity, withdrawal of consent, death, or until the Sponsor terminates the study (whichever comes first).

Tumor assessments, including radiological assessments by CT/MRI scans will be performed at Screening and subsequently every 6 weeks (± 1 week) from Cycle 1 Day 1 (C1D1) for the first 36 weeks then every 12 weeks (± 3 weeks) until disease progression, death, the start of new anticancer therapy, or patient's withdrawal of consent (whichever occurs first).

Patients who discontinue MIRV for reasons other than progressive disease (PD) will continue with tumor assessments until documentation of PD or the start of a new anticancer therapy, whichever comes first. Prior to Week 36 (from Cycle 1, Day 1), assessments should occur every 6 weeks (± 1 week) as allowed by local requirements but must occur at an interval of no more than 12 weeks. After Week 36, assessment will occur every 12 weeks (± 3 weeks) until documentation of PD or the start of new anticancer therapy.

All patients who discontinue MIRV will be followed for survival every 3 months (± 1 month) until death, lost to follow-up, withdrawal of consent for survival follow-up, or end of study (EOS) (whichever comes first). Additional survival follow-up calls may occur periodically, if needed.

All patients will receive single-agent MIRV at 6 mg/kg adjusted ideal body weight (AIBW) administered on Day 1 of every 3-week cycle (Q3W)

A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

SORAYA: A Phase 3, Single Arm Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the Investigator.

The time from initial Investigator-assessed response (CR or PR) until progressive disease (PD) as assessed by the Investigator

Adverse Events (AE's) will be evaluated according to the NCI CTCAE v5.0. AE's will be coded using the latest Medical Dictionary for Regulatory Activities (MedDRA) version and summarized per system organ class (SOC) and preferred term (PT).

The time from first dose of MIRV until Investigator-assessed radiological progressive disease (PD) or death, whichever occurs first.

The time from first dose of MIRV until death.

Serum CA-125 response determined using the Gynecologic Cancer Intergroup (GCIG) criteria.

ImmunoGen, Inc.

Digestive System Diseases

Peritoneal Neoplasms

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Anti-Infective Agents

Gemcitabine

Paclitaxel

Doxorubicin

Liposomal doxorubicin

Albumin-Bound Paclitaxel

Topotecan

Antimetabolites

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Topoisomerase I Inhibitors

5.2 mg/kg q3w with prophylactic pegfilgrastim for 2 cycles followed by 4.3 mg/kg q3w for Cycle 3 onwards

* Gemcitabine 1000 mg/m2 on Days 1, 8, and 15 q4w or 1000mg/m2 on Days 1 and 8 q3w
* Paclitaxel 80 mg/m2 on Days 1, 8, and 15 q4w
* Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 q4w
* Topotecan 4.0 mg/m2on Day 1, 8, and 15 q4w or 1.25 mg/m2 on Days 1 - 5 q3w

Luveltamab tazevibulin is an antibody-drug conjugate targeting FOLR1. It consists of an IgG1 antibody (SP8166) conjugated to cleavable 3-3-aminophenyl hemiasterlin drug-linkers at 4 sites. The active warhead (SC209) inhibits tubulin polymerization leading to mitotic arrest and cell death.

Luveltamab tazevibulin

Pegfilgrastim or pegylated G-CSF is approved and used to decrease the incidence of infection in patients receiving myelosuppressive anti-cancer drugs. It increases the proliferation and differentiation of neutrophils.

Pegfilgrastim

Gemcitabine is a chemotherapy regimen used for treating platinum-resistant ovarian cancer. It inhibits ribonucleotide reductase and DNA polymerase, hindering tumor cell growth and promoting cell death.

Paclitaxel is a chemotherapy regimen approved for treatment of previously treated ovarian cancer. It stabilizes microtubules, inhibiting tumor cell replication.

Pegylated liposomal doxorubicin is a chemotherapy regimen approved for treating platinum-resistant ovarian cancer. It inhibits DNA and RNA synthesis by intercalating between base pairs, obstructing tumor cell division.

Pegylated liposomal doxorubicin

Topotecan is a chemotherapy regimen approved for treatment of metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy. It binds to topoisomerase I inducing DNA breaks and subsequent tumor cell apoptosis.

Craig Berman, MD

Stacey Kimbell

Joseph Buscema, MD

Julia Rivera Penafiel

John Chan, MD

Hiwot Guebre-Xabiher

Ebony Hoskins, MD

Hany Fleitas

John Diaz, MD

Kathleen Murillo

Matthew Anderson, MD

Melissa Loomis

Pallavi Kumar, MD

Lindsey Allen

Susan Zweizig, MD

Nykole Starks

Lauren Bollinger, MD

Khaliq Nasrati

Brent Tierney, MD

Katy Chalamidas

Karen Finkelstein, MD

Keith Kallas

Bhavana Pothuri, MD

Stephanie Solito

Yi-Chun Lee, MD

Cara King

Amanda Jackson, MD

Jordyn Burks

Floor Backes, MD

Daniel Geyer

Thomas Reid, MD

Daniel Marangoni, PhD

Michael Gold, MD

Tawna Kiely

Charles Anderson, MD

Christopher Darus

Christopher Darus, MD

Krista Budzik

Bethany Bustamante, MD

Ashley Douglas

Russell Schilder, MD

Morgan Heim

Kristi McIntyre, MD

Dominique Marquez

Brandon Sawyer, MD

Alice Bock

Antonio Santillan-Gomez, MD

Melissa Howell

Christine Lee, MD

Kristi Ben-Barka

Chao Yin, MD

Shuo Zhang

Michelle Harrison

Emma Cet

Yeh Chen Lee

Kate Campbell

Bo Gao

Laura Pietrantonio

Lucy Gilbert, MD

Riya Agrawal

Amit Oza, MD

Anna Rapoport

Ronnie Shapira, MD

Seungyeon Kwon

Kidong Kim, MD

MyoungHee Kim

Chi-Heum Cho, MD

Seonhwa Lee

Myong Cheol Lim, MD

So Hee Choi

Young Saing Kim, MD

Saebom Kim

Vera Chia

John Chia, MD

Kathyleen Garcia David

Elaine Lim, MD

A Phase 2/3 study to investigate the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in women with ovarian cancer (including fallopian tube or primary peritoneal cancers) expressing FOLR1.

This is a randomized, multicenter, international, open-label, 2-part, Phase 2/3 study designed to assess the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in subjects with relapsed platinum-resistant epithelial ovarian cancer expressing FOLR1.

Part 1 will consist of 2 luveltamab tazevibulin dosing cohorts (Cohort A and Cohort B), with subjects randomized 1:1. Part 1 will be used to select the optimized dosing regimen.

Part 2 will further evaluate the efficacy and safety of the selected dosing regimen versus IC chemotherapy.

Luveltamab tazevibulin will be administered intravenously (IV) over a 1-hour infusion time every 3 weeks.

REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1

REFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) Versus Investigator's Choice (IC) Chemotherapy in Women With Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)

time between the date of first dose and the first date of documented progression or death

Best response of complete response (CR) or partial response (PR) per RECIST 1.1.

Time between date of first dose and date of death due to an cause or end of study.

Confirmed CR or PR from the first documented response to the date of documented disease progression or death.

Incidence and severity of adverse events (AEs) and clinical laboratory abnormalities.

GOG Foundation

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Asia-Pacific Gynecologic Oncology Trials Group (APGOT)

Sutro Biopharma, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of MORAb-003 in Patients With Solid Tumor	NCT01049061	Neoplasms Solid Tumor	MORAb-003	20 Years - 79 Years	Eisai Inc.
A Study of MORAb-003 in Patients With Solid Tumor	NCT01049061	Neoplasms Solid Tumor	MORAb-003	20 Years - 79 Years	Eisai Inc.
A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression	NCT04296890	Epithelial Ovar... Peritoneal Canc... Fallopian Tube ...	Mirvetuximab So...	18 Years -	ImmunoGen, Inc.
REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1	NCT05870748	Ovarian Cancer Epithelial Ovar... Fallopian Tube ... Primary Periton... Platinum-resist...	Luveltamab taze... Pegfilgrastim Gemcitabine Paclitaxel Pegylated lipos... Topotecan	18 Years -	Sutro Biopharma, Inc.
A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression	NCT04296890	Epithelial Ovar... Peritoneal Canc... Fallopian Tube ...	Mirvetuximab So...	18 Years -	ImmunoGen, Inc.
REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1	NCT05870748	Ovarian Cancer Epithelial Ovar... Fallopian Tube ... Primary Periton... Platinum-resist...	Luveltamab taze... Pegfilgrastim Gemcitabine Paclitaxel Pegylated lipos... Topotecan	18 Years -	Sutro Biopharma, Inc.

Spots Global Cancer Trial Database for frα

Every month we try and update this database with for frα 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 frα

Every month we try and update this database with for frα 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 frα 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.