Trials / Terminated
TerminatedNCT04628780
Study to Test the Safety and Tolerability of PF-07209960 in Advanced or Metastatic Solid Tumors
A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTI-TUMOR ACTIVITY OF PF-07209960 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 37 (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 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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PF-07209960 | PD-1 targeted IL-15 mutein |
Timeline
- Start date
- 2020-12-16
- Primary completion
- 2023-05-03
- Completion
- 2023-05-26
- First posted
- 2020-11-16
- Last updated
- 2024-07-29
- Results posted
- 2024-07-29
Locations
13 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04628780. Inclusion in this directory is not an endorsement.