PF-08046031 / Pfizer - LARVOL DELTA

Pfizer has scrapped a phase 1 antibody-drug conjugate that was being tested in solid tumors, a company spokesperson confirmed to Fierce Biotech. (FierceBiotech) - "The decision to remove PF-08046031 was made for 'business reasons,' the spokesperson explained, and 'was not related to any safety concerns or requests from regulatory authorities.'...Pfizer’s now-terminated phase 1 trial of PF-08046031 kicked off in May 2025 and was primarily focused on advanced melanoma, but was exploring lung, head-and-neck and esophageal tumors."

Discontinued • Trial termination • Cutaneous Melanoma • Esophageal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

A Study to Learn About the Study Medicine Called PF-08046031 in Advanced Melanoma and Other Solid Tumors (clinicaltrials.gov) - P1 | N=11 | Terminated | Sponsor: Pfizer | Active, not recruiting ➔ Terminated; The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns.

Trial termination • Cutaneous Melanoma • Esophageal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Study to Learn About the Study Medicine Called PF-08046031 in Advanced Melanoma and Other Solid Tumors (clinicaltrials.gov) - P1 | N=11 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=185 ➔ 11 | Trial completion date: Jun 2030 ➔ Feb 2026 | Trial primary completion date: Jun 2029 ➔ Feb 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor

A Study to Learn About the Study Medicine Called PF-08046031 in Advanced Melanoma and Other Solid Tumors (clinicaltrials.gov) - P1 | N=185 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor

PF-08046031: A promising first-in-class antibody-drug conjugate for targeting novel tumor antigen in melanoma (AACR 2025) - "At the highest dose of 6.0 mg/kg, TGI reached 87% for A2058-derived tumors and 90% for COLO853-derived tumors. These findings support the clinical development of PF-08046031 for targeting multiple solid tumors."

Cutaneous Melanoma • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MELTF • MELTF