Study of PF-07263689 in Participants With Selected Advanced Solid Tumors
NCT05061537 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2024-04-12
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
- BIOLOGICAL
-
PF-07263689
Genetically engineered oncolytic vaccinia virus
- BIOLOGICAL
-
A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/ PD-L2
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-20
- Primary Completion
- 2022-10-14
- Completion
- 2022-10-14
- FDA Drug
- Yes
Countries
- United States
Study Locations
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