Trials / Terminated
TerminatedNCT04171141
Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.
A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07062119 IN PATIENTS WITH ADVANCED GASTROINTESTINAL TUMORS
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 79 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A phase 1, open-label, dose escalation and expansion study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumors
Detailed description
This is a Phase 1, open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of PF-07062119 administered as a single agent in sequential dose levels and then in combination with anti-programmed cell death -1 protein (anti-PD-1) and in combination with an anti-vascular endothelial growth factor (anti-VEGF). In Part 1A, successive cohorts of patients will receive escalating doses of PF-007062119 and then in dose finding (Part 1B) with PF-07062119 in combination with anti-PD-1 and in combination with anti-VEGF. This study contains 2 parts, dose escalation with single agent (Part 1A) and then dose finding with PF-007062119 in combination with ant-PD-1 and in combination with anti-VEGF (Part 1B) followed by dose expansion arms as a single agent and PF-07062119 in combination with anti-PD 1 and in combination with anti-VEGF (Part 2).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-07062119 | PF-07062119 |
| DRUG | Anti-PD1 | Anti-PD1 PF-06801591 |
| DRUG | Anti-VEGF | Anti-VEGF IV (bevacizumab) |
Timeline
- Start date
- 2019-11-19
- Primary completion
- 2023-11-28
- Completion
- 2023-11-28
- First posted
- 2019-11-20
- Last updated
- 2025-01-16
- Results posted
- 2025-01-16
Locations
19 sites across 3 countries: United States, Australia, Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04171141. Inclusion in this directory is not an endorsement.