NCT05061537

Study of PF-07263689 in Participants With Selected Advanced Solid Tumors

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY AND PHARMACODYNAMICS OF PF-07263689, EITHER ALONE OR IN COMBINATION WITH AN ANTI-PD-1 ANTIBODY, IN PREVIOUSLY TREATED PARTICIPANTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC SOLID TUMORS

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and expansion study intended to evaluate the safety, viral load kinetics and shedding, pharmacodynamic, and anti-tumor activity of PF-07263689, either alone or in combination with sasanlimab (an investigational anti-programmed cell death protein 1 \[PD-1\] antibody), in patients with selected locally advanced or metastatic solid tumors who have exhausted all available standard of care therapies available to them. The study consists of 2 parts: Part 1 dose escalation for PF-07263689 monotherapy (Part 1A) and in combination with sasanlimab (Part 1B), followed by Part 2 dose expansion for the combination therapy.

Conditions

• Renal Cell Cancer
• Melanoma
• Non-Small-Cell Lung Cancer
• Hepatocellular Cancer
• Bladder Cancer
• Sarcoma
• Head and Neck Cancer
• Colorectal Cancer
• Ovarian Cancer
• Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	PF-07263689	Genetically engineered oncolytic vaccinia virus
BIOLOGICAL	Sasanlimab	A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/ PD-L2

Timeline

• Start date: 2021-10-20
• Primary completion: 2022-10-14
• Completion: 2022-10-14
• First posted: 2021-09-29
• Last updated: 2024-04-12
• Results posted: 2024-04-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study