TerminatedPhase 1

A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors

Stopped: The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns

United States250 participantsStarted 2022-01-12

Plain-language summary

The purpose of the study is to test the safety of the medicine called Felmetatug Vedotin alone and with pembrolizumab in participants with solid tumors. It will also look at the side effects of this medicine. A side effect is anything a medicine does to the body besides treating the disease. This study is seeking for participants who either have cancer: * that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable), * has spread through the body (metastatic), or have some cancer left over after surgery. This study will have five parts. * Parts A and B of the study will find out how much Felmetatug Vedotin should be given to participants. * Part C will use the amount found in Parts A and B to find out how safe Felmetatug Vedotin is and if it works to treat solid tumor cancers. * Part D will find out if and how much Felmetatug Vedotin can be given with pembrolizumab. * Part E will use the amount found in Part D to find out how safe Felmetatug Vedotin with pembrolizumab is and if it works to treat triple negative breast cancer.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: For Parts A, B, and C: * Participants must have one of the following histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor types: * High-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer * HER2-negative, HR positive breast cancer * Triple-negative breast cancer (TNBC) * Endometrial carcinoma * Non-small cell lung cancer (Squamous cell carcinoma \[SqCC\], Adenocarcinoma \[AC\]) * Cholangiocarcinoma or gallbladder carcinoma * Adenoid cystic carcinoma (ACC) For Part D: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC. For Part E: * Cohort E1: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC and must have CPS≥10 by local testing * Cohort E2: Participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic TNBC and must have CPS\<10 by local testing * Cohort E3: Participants must have triple negative breast cancer with residual disease following neoadjuvant therapy and definitive surgery * Parts A and B: Participants must have disease that is relapsed or refractory or be intolerant to SOC therapies, and, in the judgement of the investigator, should have no appropriate SOC therapeutic option * Part C: Participants must have disease that is relapsed or refractory or be intolerant to S…

What they're measuring

Number of participants with adverse events (AEs)

Timeframe: Through 30 days after last study treatment, up to approximately 5 years

Number of participants with laboratory abnormalities

Timeframe: Through 30-37 days after last study treatment, up to approximately 5 years

Number of participants with dose limiting toxicities (DLTs)

Timeframe: Up to 28 days

Number of participants with dose limiting toxicities (DLTs) and overall safety by dose level

Timeframe: Through 30-37 days after last study treatment; up to approximately 5 years

Trial details

NCT IDNCT05194072

SponsorSeagen, a wholly owned subsidiary of Pfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-14

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