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

NCT05194072 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-01-09

No results posted yet for this study

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.

Conditions

  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Triple Negative Breast Neoplasms
  • HER2 Negative Breast Neoplasms
  • Hormone Receptor Positive Breast Neoplasms
  • Endometrial Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Cholangiocarcinoma
  • Gallbladder Carcinoma
  • Adenoid Cystic Carcinoma

Interventions

DRUG

Felmetatug Vedotin

Given into the vein (IV; intravenously)

DRUG

Pembrolizumab

400 mg every 6 weeks, given by IV

Sponsors & Collaborators

  • Seagen, a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-12
Primary Completion
2025-05-14
Completion
2025-05-14
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05194072 on ClinicalTrials.gov