PF-07257876 / Pfizer - LARVOL DELTA

Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors. (clinicaltrials.gov) - P1 | N=29 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

'CD47 fails again' Pfizer also 'suspends development of phase 1 ‘CD47xPD-L1' [Google translation] (Biospectator) - “Pfizer disclosed the pipeline update status at this year's third quarter earnings announcement on the 31st of last month....and announced the news of the discontinuation of development of the CD47 asset. In this pipeline update, Pfizer announced that it will discontinue the development of the CD47xPD-L1 bispecific antibody 'PF-07257876', which was in phase 1 clinical trials for non-small cell lung cancer (NSCLC). Pfizer did not specifically mention the reason for discontinuing development, but the asset was confirmed to have poor efficacy results in phase 1 clinical trials last June."

Discontinued • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Addressing Domain Specificity in the Development of a Cell-Based Binding Assay for the Detection of Neutralizing Antibodies Against a CD47xPD-L1 Bispecific Antibody. (PubMed, AAPS J) - "PF-07257876 is a bispecific antibody being developed for the treatment of certain advanced or metastatic solid tumors...Specifically, mock samples containing a mixture of NAb positive controls against both binding domains of the bispecific antibody produced false-negative results in the cell-based binding assay. An adaptation made to the standard BEAD approach restored domain-specific NAb detection, while also contributing to an assay sensitivity of 1 µg/mL in the presence of a clinically relevant drug tolerance level of up to 400 µg/mL."

Journal • Oncology • Solid Tumor

Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors. (clinicaltrials.gov) - P1 | N=28 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=90 ➔ 28 | Trial completion date: Mar 2026 ➔ Oct 2023 | Trial primary completion date: Nov 2024 ➔ Oct 2023

Enrollment change • Enrollment closed • IO biomarker • Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Phase 1 first-in-human study of PF-07257876, a novel CD47/PD-L1 bispecific checkpoint inhibitor, in patients with PD-1/PD-L1-refractory and -naïve advanced solid tumors. (ASCO 2023) - P1 | "PF-07257876 was well tolerated with manageable toxicity. Incidence and grade of anemia or thrombocytopenia were manageable. Target engagement of CD47 and PD-L1 in peripheral blood was high."

Checkpoint inhibition • Clinical • IO biomarker • Metastases • P1 data • Anemia • Dermatology • Head and Neck Cancer • Hematological Disorders • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thrombocytopenia • CCL3 • CD47 • CXCL9 • IFNG • IL6 • TNFA

Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors. (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Pfizer | Trial primary completion date: Dec 2025 ➔ Nov 2024

IO biomarker • Metastases • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors. (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Pfizer | Trial completion date: Jul 2025 ➔ Dec 2025 | Trial primary completion date: Jul 2025 ➔ Dec 2025

IO biomarker • Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors. (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: Pfizer | Trial completion date: Jul 2024 ➔ Jul 2025 | Trial primary completion date: Jul 2024 ➔ Jul 2025

IO biomarker • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors. (clinicaltrials.gov) - P1; N=90; Recruiting; Sponsor: Pfizer; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • IO biomarker • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors. (clinicaltrials.gov) - P1; N=90; Not yet recruiting; Sponsor: Pfizer

Clinical • IO biomarker • New P1 trial • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1