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New hope for Hard-to-Treat cancers: experimental drug enters human trials

NCT ID NCT05208762

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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Updated 2 times

Summary

This early-stage study tests a new drug called PF-08046054/SGN-PDL1V, alone or with another drug (pembrolizumab), in people with advanced solid tumors like lung, head and neck, esophageal, breast, stomach, endometrial, pancreatic, or liver cancer. The main goals are to find safe doses and understand side effects. About 714 participants will take part across five parts of the study.

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

About 714 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Jan 2029

An estimate. End dates often move.

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: * Parts A and B: * Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types * Non-small cell lung cancer (NSCLC) * Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal cancer) * Esophageal squamous cell carcinoma (SCC) * Triple negative breast cancer (TNBC) * Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option * Participants must have PD-L1 expression based on historical testing * Part C: * Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types * HNSCC * Participants with HNSCC must have histologically or cytologically-confirmed HNSCC * NSCLC * Participants must have histologically or cytologically-confirmed NSCLC. Participants with SCC and non--SCC histology are eligible. Note: Participants with a neuroendocrine component or histology are not eligible. * Esophageal SCC * Pancreatic cancer * Hepatocellular carcinoma * TNBC * Gastric cancer * Endometrial cancer * Participants must have been previously tested for PD-L1 expression and should have PD-L1 expression ≥1 or \<1 by CPS or TPS based on historical testing * Part D and Part E: * Participants must have histologically or cytologically-confirmed disease of the HNSCC or NSCLC * Participants must have PD-L1 expression based on historical testing * Participants with NSCLC; PD-L1 expression ≥ 1% by TPS * Participants with HNSCC; PD--L1 expression ≥1 by CPS * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Measurable disease per RECIST v1.1 at baseline Exclusion Criteria: * History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy. * 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 of corticosteroids prescribed for symptoms associate with brain metastases for at least 7 days prior to first dose of study treatment * Lepto-meningeal disease * Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. This duration of time will vary according to the half-life of the specific agent. * Previous receipt of an monomethylauristatin E (MMAE)-containing agent. * Pre-existing neuropathy ≥Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. There are additional inclusion criteria. The study center will determine if criteria for participations are met.

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrium neoplasm esophageal squamous cell carcinoma gastric cancer gastric neoplasm head and neck squamous cell carcinoma hepatocellular carcinoma malignant pancreatic neoplasm melanoma non-small cell lung carcinoma ovarian neoplasm pancreatic adenocarcinoma Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma

As listed by the trial registrant

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

Carcinoma, non-small-cell lung Endometrial cancer Esophageal squamous cell carcinoma Gastric cancer Hepatocellular carcinoma Melanoma Ovarian neoplasms Pancreatic adenocarcinoma Squamous cell carcinoma of the head and neck Triple negative breast neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    62 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Apotheke-Zytostatika Studien Charite- Universitatsmedizin Berlin Campus Virchow Klinkum

    RECRUITING

    Berlin, 13353, Germany

  • Azienda Ospedaliera Universitaria Integrata Verona - Policlinico G.B Rossi

    RECRUITING

    Verona, Veneto, 37134, Italy

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Beijing Friendship Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100050, China

  • Beijing Friendship hospital, Capital Medical University

    RECRUITING

    Beijing, China

  • CETIR Viladomat

    RECRUITING

    Barcelona, Other, 08029, Spain

  • Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B Rossi

    RECRUITING

    Verona, Other, 37134, Italy

  • Chao Family Comprehensive Cancer Center and Ambulatory Care

    RECRUITING

    Irvine, California, 92612, United States

  • Charite Comprehensive Cancer Center

    RECRUITING

    Berlin, 10117, Germany

  • Charite Universitatsmedizin Berlin

    RECRUITING

    Berlin, 12200, Germany

  • Clinique Ambroise Pare

    RECRUITING

    Neuilly-sur-Seine, 92200, France

  • Diagnostic Centre

    RECRUITING

    London, Others, W1G 7AF, United Kingdom

  • Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative lstituto Europeo di Oncologia

    RECRUITING

    Milan, Milan, 20141, Italy

  • Gustave Roussy Institute

    RECRUITING

    Villejuif, 94805, France

  • Gustave Roussy Institute - Service pharmacie

    RECRUITING

    Villejuif, 94805, France

  • Hospital Duran I Reynals-Institut Català d'Oncologia L'Hospitalet (ICO L'Hospitalet)

    RECRUITING

    Barcelona, Other, 08908, Spain

  • Hospital Quiron Salud Barcelona

    RECRUITING

    Barcelona, 08023, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hôpital Saint André - CHU Bordeaux

    RECRUITING

    Bordeaux, 33075, France

  • Institut Curie

    RECRUITING

    Paris, 75005, France

  • Institut Jules Bordet

    RECRUITING

    Anderlecht, 1070, Belgium

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Karmanos Cancer Institute

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • NEXT Oncology Barcelona - IOB - Hospital Quironsalud Barcelona

    RECRUITING

    Barcelona, 08023, Spain

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • NEXT Virginia, LLC

    RECRUITING

    San Antonio, Texas, 78229, United States

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

  • Pharmacy: Royal Marsden Hospital

    RECRUITING

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Radiology

    RECRUITING

    London, W1G 8PP, United Kingdom

  • Royal Marsden Hospital

    RECRUITING

    Sutton, Surrey, SM2 5PT, United Kingdom

  • START Madrid - CIOCC - Hospital Universitario HM Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

  • START Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

  • Sarah Cannon Research Institute

    RECRUITING

    London, W1G 6AD, United Kingdom

  • Shanghai East Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200123, China

  • Shizuoka Cancer Center

    RECRUITING

    Nagaizumi-cho, Shizuoka, 411-8777, Japan

  • South Texas Accelerated Research Therapeutics, LLC

    RECRUITING

    San Antonio, Texas, 78229, United States

  • The Harley Street Clinic (THSC)

    RECRUITING

    London, Other, W1G 8BJ, United Kingdom

  • The Netherlands Cancer Institute

    RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • The Royal Marsden NHS Foundation Trust

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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

    RECRUITING

    Houston, Texas, 77030, United States

  • UC Irvine Health - Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 92868, United States

  • UOC Oncologia - IRCCS Azienda Ospedaliero Universitaria Bologna

    RECRUITING

    Bologna, 40138, Italy

  • UT Southwestern - Simmons Cancer Center - Fort Worth

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • UT Southwestern - Simmons Cancer Center - Richardson/Plano

    RECRUITING

    Richardson, Texas, 75080, United States

  • UT Southwestern Medical Center - Redbird

    RECRUITING

    Dallas, Texas, 75237, United States

  • Univ. of TX Southwestern Medical Center - Zale Lipshy University Hospital

    RECRUITING

    Dallas, Texas, 75390, United States

  • University Health Network

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • University Health Network, Princess Margaret Hospital

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University Of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35249, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Alabama at Birmingham, IDS Pharmacy

    RECRUITING

    Birmingham, Alabama, 35249, United States

  • University of California Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of California, Davis Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Texas Southwestern Medical Center - Simmons Cancer Center

    RECRUITING

    Dallas, Texas, 75235, United States

  • University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital

    RECRUITING

    Dallas, Texas, 75390, United States

  • lnstitut Curie Pharmacy

    RECRUITING

    Paris, 75005, France

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