Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors
NCT04628780 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37
Last updated 2024-07-29
Summary
This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic, and potential clinical benefit of PF-07209960, an anti-PD-1 targeting IL-15 fusion protein, in participants with selected locally advanced or metastatic solid tumors for whom no standard therapy is available, or would not be an appropriate option in the opinion of the participant and their treating physician, or participants who have refused standard therapy.
The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07209960, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.
Conditions
- Non-small-cell Lung Cancer
- Squamous Cell Carcinoma of the Head and Neck
- Renal Cell Carcinoma
- Urothelial Carcinoma
- Colorectal Carcinoma
- Ovarian Carcinoma
Interventions
- BIOLOGICAL
-
PF-07209960
PD-1 targeted IL-15 mutein
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-16
- Primary Completion
- 2023-05-03
- Completion
- 2023-05-26
- FDA Drug
- Yes
Countries
- United States
Study Locations
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