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New antibody drug takes aim at Hard-to-Treat cancers

NCT ID NCT04881045

Disease control Sponsor: 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested a new drug called PF-07257876 in 29 people with advanced lung, head/neck, or ovarian cancers that had stopped responding to other treatments. The drug is a bispecific antibody designed to help the immune system attack cancer cells. The main goals were to check safety and find the right dose, not yet to prove it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PF-07257876 (a bispecific antibody targeting CD47 and PD-L1)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced cancers that have stopped responding to standard therapies.
What could go wrong
This is a very early (Phase 1) trial with only 29 participants, so it is primarily testing safety and dosing. It is too soon to know if the drug will shrink tumors or improve survival, and side effects are unknown.

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

29 people

The number who actually took part.

Started

Aug 2021

Finished

Oct 2023

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: * Histological/cytological diagnosis of selected advanced or metastatic tumor * Prior treatment with PD-1 (Programmed cell death 1) or PD-L1 (programmed death-ligand 1) in NSCLC and SCCHN or platinum-based therapy in Ovarian cancer * Confirmed radiographic progression of disease * PD-L1 IHC positivity ≥1% * Have ≥1 measurable lesion as defined by RECIST 1.1 that has not been previously irradiated * Eastern Cooperative Oncology Group performance status 0-1 * Adequate hematologic, renal and liver functions * Resolved acute effects of any prior therapy * Participants in Part 1 must be able to provide archival tumor tissue collected within the prior 6 months or consent to undergo a fresh biopsy during screening. Participants enrolled to the MTD (Maximum Tolerated Dose) cohort in Part 1 must consent to mandatory paired pre-treatment and on-treatment biopsies. Participants in Part 2 must consent to a pre-treatment biopsy and a subset of patients must consent to a paired on-study biopsy as well until the Sponsor deems an adequate number have been received. Exclusion Criteria: * Participants with known brain metastasis larger than 4 cm or that is symptomatic. New brain metastases detected at screening. Participants with previously diagnosed brain metastases are eligible if they have completed treatment and recovered from acute effects prior to study entry. * Abnormal neurological assessment by investigator * Other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ * Major surgery or radiation therapy within 4 weeks prior to planned first dose * Last systemic anti-cancer therapy within 28 days or 5 half-lives (whichever is shorter) prior to planned first dose (6 weeks for mitomycin C or nitrosoureas) * Active bleeding disorder in the past 6 months prior to first dose * History of clinically significant severe immune mediated adverse event that was considered related to prior immune modulatory therapy and required immunosuppressive therapy (other than hormone replacement therapy) * History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (ie, bronchiolitis obliterans, cryptogenic organizing pneumonia), evidence of active pneumonitis on screening chest CT(computer tomography) scan * Anticoagulation with vitamin K antagonists or factor Xa inhibitors is not allowed * Treatment with chronic systemic corticosteroids or other immunosuppressive medications * Participation in other studies involving investigational drug(s) within 4 weeks prior to planned first dose * Active, uncontrolled bacterial, fungal, or viral infection, Hepatitis B, Hepatitis C, or Human immunodeficiency virus (HIV) infection * Active COVID-19/SARS-CoV2 * Pregnant or breastfeeding female participant * Organ transplant requiring immunosuppressive treatment or prior allogeneic bone marrow or hematopoietic stem cell transplant * Significant cardiac or pulmonary conditions or events within previous 6 months

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Conditions

The condition(s) this trial relates to.

Head and Neck Neoplasms head and neck squamous cell carcinoma lung neoplasm Neoplasm Metastasis non-small cell lung carcinoma ovarian cancer Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

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

Non-small cell lung cancer Ovarian cancer Squamous cell carcinoma of the head and neck

Contacts and locations

Locations

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Duke Cancer Institute

    Durham, North Carolina, 27710, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703, United States

  • Highlands Oncology Group

    Rogers, Arkansas, 72758, United States

  • Highlands Oncology Group

    Springdale, Arkansas, 72762, United States

  • Hoag Hospital Irvine

    Irvine, California, 92618, United States

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663, United States

  • Hospital Clinico de Valencia

    Valencia, Valenciana, Comunitat, 46010, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, Madrid, Comunidad de, 28009, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona], 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041, Spain

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Keck Hospital of USC

    Los Angeles, California, 90033, United States

  • Keck Hospital of USC Pasadena

    Pasadena, California, 91105, United States

  • Keck School of Medicine of USC

    Los Angeles, California, 90033, United States

  • LAC+USC Medical Center

    Los Angeles, California, 90033, United States

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129, United States

  • Siteman Cancer Center - St Peters

    City of Saint Peters, Missouri, 63376, United States

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141, United States

  • Siteman Cancer Center-North County

    Florissant, Missouri, 63031, United States

  • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate

    Los Angeles, California, 90025, United States

  • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate (Emergency Back-Up Only)

    Santa Monica, California, 90404, United States

  • The Miriam Hospital

    Providence, Rhode Island, 02906, United States

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • UPMC Hillman Cancer Center - Camp Hill

    Camp Hill, Pennsylvania, 17011, United States

  • UPMC Hillman Cancer Center - Carlisle

    Carlisle, Pennsylvania, 17015, United States

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505, United States

  • UPMC Memorial

    York, Pennsylvania, 17408, United States

  • UPMC Pinnacle - Community Osteopathic / Medical Sciences Pavilion (MSP)

    Harrisburg, Pennsylvania, 17109, United States

  • UPMC Pinnacle - Ortenzio Cancer Center (OCC)

    Mechanicsburg, Pennsylvania, 17050, United States

  • UPMC Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232, United States

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

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