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PF-07257876 · 1 trial · 3 indications
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
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.
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
Tumor response based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
| Arm | Type | Description |
|---|---|---|
| Dose Escalation (Part 1) | EXPERIMENTAL | Participants will receive PF-07257876 at escalating dose levels. |
| Dose Expansion (Part 2) - Cohort 1 (NSCLC) | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Participants with squamous cell carcinoma of the head and neck (SCCHN) will receive PF-07257876 at the recommended dose from Part 1. |
| Name | Type | Description |
|---|---|---|
| PF-07257876 | BIOLOGICAL | CD47-PDL-1 bispecific antibody |
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...
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PF-07257876 is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors, including non-small cell lung cancer. It is not yet approved for any indication and remains in clinical development. The Phase 1 trial also enrolled participants with squamous cell carcinoma of the head and neck and ovarian cancer.
PF-07257876 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 1 study evaluating the drug in participants with selected advanced tumors. No other developer or partnership has been disclosed for this asset.
PF-07257876 is in Phase 1 clinical development. The single registered trial, NCT04881045, was a Phase 1 study that has been completed. The drug is investigational and has not been approved by the FDA or any other regulatory agency for non-small cell lung cancer or any other indication.
PF-07257876 has been evaluated in one clinical trial, NCT04881045, titled a study to test the safety and tolerability of PF-07257876 in participants with selected advanced tumors. The Phase 1 trial enrolled 29 participants across the United States and Spain and is now completed. It included non-small cell lung cancer, squamous cell carcinoma of the head and neck, and ovarian cancer.
Yes, the PF-07257876 Phase 1 trial NCT04881045 was biomarker selected, meaning participants were enrolled based on specific tumor biomarker criteria. The study evaluated the monoclonal antibody in adults 18 years and older with selected advanced tumors, including non-small cell lung cancer, and enrolled 29 participants.