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PF-07257876

Phase 1

Non-Small Cell Lung Cancer | Monoclonal antibody | Oncology |Pfizer, Inc.|Last Updated: Jun 2, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment29

FDA Designations

No designations recorded

Clinical trial landscape

PF-07257876 · 1 trial · 3 indications

Phase 1 1
NCT04881045Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors.Non-Small Cell Lung Cancer
COMPLETED29 Analytics
PHASE1COMPLETED
Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors.
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with dose limiting toxicities (DLTs) in Dose Escalation (Part 1)
Baseline through end of Cycle 1 (each cycle is 28 days)

DLTs will be evaluated during Cycle 1 (a cycle is 28 days) in Part 1. The number of DLTs will be used to determine the optimal dose

Number of participants with adverse events (AEs)
Baseline through up to 2 years

AEs characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0), timing, seriousness, and relationship to study therapy.

Number of participants with clinically significant laboratory abnormalities
Baseline through up to 2 years

Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.

Objective response rate (ORR) in the Expansion cohorts (Part 2)
Baseline through up to 2 years or until disease progression

Tumor response based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary Endpoints

Single dose Pharmacokinetics (PK) parameter: Maximal concentration (Cmax) in Part 1
Cycle 1, Cycle 2, Cycle 3, Cycle 4, and pre-dose on Day 1 at Cycle 5 and every third cycle thereafter (all cycles are 28 days) and at End of Treatment, up to 2 years
Single dose PK parameter: Time to maximal plasma concentration (Tmax) in Part 1
Cycle 1, Cycle 2, Cycle 3, Cycle 4, and pre-dose on Day 1 at Cycle 5 and every third cycle thereafter (all cycles are 28 days) and at End of Treatment, up to 2 years
Single dose PK parameter: Area under the Curve (AUClast) in Part 1
Cycle 1, Cycle 2, Cycle 3, Cycle 4, and pre-dose on Day 1 at Cycle 5 and every third cycle thereafter (all cycles are 28 days) and at End of Treatment, up to 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation (Part 1)EXPERIMENTALParticipants will receive PF-07257876 at escalating dose levels.
Dose Expansion (Part 2) - Cohort 1 (NSCLC)EXPERIMENTALParticipants with non-small cell lung cancer (NSCLC) will receive PF-07257876 at the recommended dose from Part 1.
Dose Expansion (Part 2) - Cohort 2 (SCCHN)EXPERIMENTALParticipants with squamous cell carcinoma of the head and neck (SCCHN) will receive PF-07257876 at the recommended dose from Part 1.

Interventions

NameTypeDescription
PF-07257876BIOLOGICALCD47-PDL-1 bispecific antibody
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites43

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...

Countries:United StatesSpain
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Recent Changes (Last 90 Days)

MEDIUMJul 3, 2026NCT04881045TRIAL_REMOVED: changed
MEDIUMJul 3, 2026NCT04881045TRIAL_REMOVED: changed
MEDIUMJul 3, 2026NCT04881045TRIAL_REMOVED: changed

Frequently asked questions about PF-07257876

What is PF-07257876 used for?

PF-07257876 is an investigational monoclonal antibody being studied for the treatment of non-small cell lung cancer. It is also being evaluated in squamous cell carcinoma of the head and neck and ovarian cancer. The drug is in Phase 1 clinical development and is not yet approved.

What does PF-07257876 target?

PF-07257876 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. It is being studied for its potential to treat certain advanced tumors, including non-small cell lung cancer.

Who makes PF-07257876?

PF-07257876 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical trials.

What phase is PF-07257876 in?

PF-07257876 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 1 trial has been completed to evaluate its safety and tolerability.

What clinical trials is PF-07257876 in?

PF-07257876 has been studied in a Phase 1 clinical trial with the identifier NCT04881045. This trial, titled 'Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors,' enrolled 29 participants and has been completed.

Is PF-07257876 the same as any other drug?

PF-07257876 is not known to have alternative names. It is a distinct investigational monoclonal antibody developed by Pfizer for the treatment of certain advanced tumors, including non-small cell lung cancer.