PF-07260437 / Pfizer - LARVOL DELTA

A phase 1 study of PF-07260437, a B7-H4 × CD3 bispecific T-cell engager, in patients with advanced or metastatic breast, ovarian, and endometrial cancer. (PubMed, Invest New Drugs) - P1 | "TRIAL REGISTRATION NUMBER: NCT05067972. REGISTRATION DATE: 5 October, 2021."

First-in-human • Journal • P1 data • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • VTCN1

A Novel B7-H4xCD3 Bispecific T Cell Engager (PF-07260437) Synergizes with Breast Cancer Standard of Care and Immune-Checkpoint Therapies. (PubMed, Mol Cancer Ther) - "Additionally, combining PF-07260437 with standard of care (palbociclib plus fulvestrant) and a checkpoint inhibitor (anti-PD-1) showed combinatorial benefits in an immune competent in vivo model. Finally, the manageable toxicity profile of PF-07260437 was highlighted in an exploratory toxicology study in cynomolgus monkeys. These data support the clinical testing of PF-07260437 for treating B7-H4 expressing solid tumors, including breast cancer."

IO biomarker • Journal • Breast Cancer • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor • CD8 • VTCN1

C4431001: A Study of PF-07260437 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Terminated | Sponsor: Pfizer | Trial completion date: Jan 2024 ➔ Oct 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jan 2024 ➔ Oct 2023; Pfizer has made an internal business decision to not continue further development of PF-07260437. This decision was not due to major safety concerns or requests from any regulatory authorities.

Metastases • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Endometrial Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • HER-2 • VTCN1

C4431001: A Study of PF-07260437 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=25 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=100 ➔ 25 | Trial completion date: Sep 2025 ➔ Jan 2024 | Trial primary completion date: Sep 2025 ➔ Jan 2024

Enrollment change • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • HER-2 • VTCN1

C4431001: A Study of PF-07260437 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Pfizer | Trial completion date: Mar 2025 ➔ Sep 2025 | Trial primary completion date: Mar 2025 ➔ Sep 2025

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • HER-2 • VTCN1

C4431001: A Study of PF-07260437 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: Pfizer; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Breast Cancer • Endometrial Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • HER-2