PF-08046037 / Pfizer - LARVOL DELTA

A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=399 ➔ 9 | Trial completion date: Sep 2029 ➔ Apr 2026 | Trial primary completion date: Sep 2028 ➔ Mar 2026

Enrollment change • Enrollment closed • Monotherapy • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies (clinicaltrials.gov) - P1 | N=399 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting | Trial completion date: Feb 2029 ➔ Jul 2029 | Trial primary completion date: Feb 2028 ➔ Jul 2028

Enrollment open • Monotherapy • Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies (clinicaltrials.gov) - P1 | N=399 | Not yet recruiting | Sponsor: Pfizer

Monotherapy • New P1 trial • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

PF-08046037, a PD-L1 targeted TLR7 agonist ISAC, drives innate immune activation and anti-tumor efficacy in preclinical in vitro and in vivo models (AACR 2025) - "The in vivo pharmacodynamic effects of PF-08046037 align with its intended mechanism of action, including acute tumor inflammation, loss of CD206+ suppressive macrophages, upregulation of activation and costimulatory molecules on APCs in tumors and tumor-draining lymph nodes (tdLN), and increased activity of cytotoxic cells. Collectively, these data highlight the therapeutic potential of targeted TLR7 agonist delivery to PD-L1-expressing APCs in cancer and support the clinical investigation of PF-08046037 in advanced malignancies."

IO biomarker • Preclinical • Oncology • MRC1 • PD-L1