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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment29
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04881045Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors.PHASE1 COMPLETED 29 — — Aug 18, 2021Oct 24, 2023Jun 2, 202643 United States, Spain
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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 — 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 406 trials
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