Status:
TERMINATED
A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors
Lead Sponsor:
Seagen, a wholly owned subsidiary of Pfizer
Conditions:
Ovarian Neoplasms
Peritoneal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 m...
Eligibility Criteria
Inclusion
- 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 SOC therapies.
- Part D and E1/E2: Participants must have had no prior treatment for locally advanced unresectable or metastatic TNBC
- Part E3: Participants must have completed at least 6 cycles of neoadjuvant therapy for locally advanced unresectable or metastatic TNBC
- Tumor tissue is required for enrollment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Measurable disease per RECIST version 1.1 at baseline (not applicable for E3 participants).
Exclusion
- History of another malignancy within 3 years before the first dose of study drug. Any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
- Known active central nervous system metastases. Participants with previously treated brain metastases may participate provided they:
- are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment
- have no new or enlarging brain metastases
- and are off corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study treatment.
- Carcinomatous meningitis
- Previous receipt of an MMAE-containing agent or an agent targeting B7-H4
- Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
- Corneal disease or injury requiring treatment or active monitoring
Key Trial Info
Start Date :
January 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05194072
Start Date
January 12 2022
End Date
May 14 2025
Last Update
January 9 2026
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
UCHealth Sue Anschutz-Rodgers Eye Center
Aurora, Colorado, United States, 80045
2
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, United States, 80045
3
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, United States, 80045
4
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora, Colorado, United States, 80045