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New cancer drug trial halted early – what we know

NCT ID NCT05194072

Disease control Sponsor: Seagen, a wholly owned subsidiary of Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug, felmetatug vedotin, alone or with pembrolizumab, in people with advanced solid tumors like ovarian, breast, and lung cancer. The goal was to check safety and find the right dose. The trial was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

250 people

The number who actually took part.

Started

Jan 2022

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

adenoid cystic carcinoma cholangiocarcinoma endometrial carcinoma endometrium neoplasm fallopian tube cancer fallopian tube neoplasm gallbladder carcinoma gallbladder neoplasm Her2-receptor negative breast cancer hormone receptor-positive breast cancer non-small cell lung carcinoma ovarian cancer ovarian neoplasm ovarian serous adenocarcinoma peritoneal neoplasm primary peritoneal carcinoma triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adenoid cystic carcinoma Carcinoma, non-small-cell lung Cholangiocarcinoma Endometrial neoplasms Fallopian tube neoplasms Gallbladder carcinoma HER2 negative breast neoplasms Hormone receptor positive breast neoplasms Ovarian neoplasms Peritoneal neoplasms Triple negative breast neoplasms

Contacts and locations

Locations

  • AdventHealth Celebration Infusion Center

    Celebration, Florida, 34747, United States

  • AdventHealth Medical Group Oncology Research at Celebration

    Celebration, Florida, 34747, United States

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46227, United States

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46250, United States

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46256, United States

  • Florida Cancer Specialists

    Orlando, Florida, 32827, United States

  • Hamato-Onkologische Phase 1 Unit der Charite/Charite Research Organisation

    Berlin, 12200, Germany

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • Northwestern Medical Group

    Chicago, Illinois, 60611, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Presbyterian/St Lukes Medical Center

    Denver, Colorado, 80218, United States

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • START Madrid-Hospital Universitario HM Sanchinarro

    Madrid, 28050, Spain

  • START Midwest

    Grand Rapids, Michigan, 49546, United States

  • START Mountain Region

    West Valley City, Utah, 84119, United States

  • Sarah Cannon Research Institute

    London, W1G 6AD, United Kingdom

  • Sarah Cannon Research Institute - Pharmacy

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    Orlando, Florida, 32827, United States

  • South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas, 78229, United States

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6, Canada

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030, United States

  • The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services

    Houston, Texas, 77030, United States

  • UCHealth Sue Anschutz-Rodgers Eye Center

    Aurora, Colorado, 80045, United States

  • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

    Aurora, Colorado, 80045, United States

  • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

    Aurora, Colorado, 80045, United States

  • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

    Aurora, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.