Description:
A phase 1, open-label, dose escalation and expansion study of PF-07062119 in patients with
selected advanced or metastatic gastrointestinal tumors
Title
- Brief Title: Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
C3861001
- SECONDARY ID:
GUCY2C
- NCT ID:
NCT04171141
Conditions
- Gastrointestinal Tumors
- Colorectal Adenocarcinomas
- Gastric Adenocarcinomas
- Esophageal Adenocarcinomas
Interventions
Drug | Synonyms | Arms |
---|
PF-07062119 | | Dose Escalation |
Anti-PD1 | | Dose Expansion Arm C |
Anti-VEGF | | Dose Expansion Arm C |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Escalation | Experimental | Single Agent Dose Escalation | |
Dose Finding Anti-PD-1 Combination | Experimental | Part 1B PF-07062119 plus anti-PD-1 | |
Dose Finding anti-VEGF Combination | Experimental | Part 1B PF-07062119 plus anti-VEGF | |
Dose Expansion Arm A | Experimental | PF-07062119 as a Single Agent in CRC | |
Dose Expansion Arm B | Experimental | PF-07062119 in Combination with anti-PD-1 in CRC | |
Dose Expansion Arm C | Experimental | PF-07062119 in Combination with anti-VEGF in CRC | - PF-07062119
- Anti-PD1
- Anti-VEGF
|
Dose Expansion Arm D | Experimental | PF-07062119 in Combination with either anti-PD-1 or anti-VEGF in various Tumor Types | - PF-07062119
- Anti-PD1
- Anti-VEGF
|
Eligibility Criteria
Inclusion Criteria:
- For Part 1 and Part 2, diagnosis of advanced/metastatic colorectal, gastric or
esophageal adenocarcinoma that is resistant to standard therapy or for which no local
regulatory approved standard therapy is available that would confer significant
benefit.
- For Part 2, diagnosis of colorectal adenocarcinoma that is resistant to standard
therapy or for which no standard therapy is available
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Measurable disease or non-measurable disease and refractory to or intolerant of
existing therapies (Part 1)
- Measurable disease as defined by RECIST 1.1 is required (Part 2)
Exclusion Criteria:
- Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases
- Other active malignancy within 3 years prior to randomization, except for adequately
treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Major surgery or radiation within 3 weeks prior to study entry
- Last anti-cancer treatment within 4 weeks prior to study entry
- Active or history of clinically significant autoimmune disease that required systemic
immunosuppressive medication
- Active or history of clinically significant gastrointestinal disease
- Participation in other studies involving investigational drug(s) within 2 weeks prior
to study entry
- Pregnant or breastfeeding female patients
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of participants with Dose-limiting toxicities (DLT) in Cycle 1 |
Time Frame: | Baseline up to 28 days (or 42 days as applicable) |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
Time Frame: | Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies (Nab) for PF-07062119 |
Time Frame: | Up to approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies anti-PD1 |
Time Frame: | Up to approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies (Nab) for anti-VEGF |
Time Frame: | Up to approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Apparent Clearance (CL/F) |
Time Frame: | Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] |
Time Frame: | Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Maximum Observed Plasma Concentration (Cmax) |
Time Frame: | Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Time to Reach Maximum Observed Plasma Concentration (Tmax) |
Time Frame: | Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Terminal Half-Life (t1/2) |
Time Frame: | Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Objective Response - Number of Participants With Objective Response for Dose Escalation |
Time Frame: | Baseline up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Objective Response - Number of Participants With Objective Response for Dose Finding portion |
Time Frame: | Baseline up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Minimum Observed Plasma Trough Concentration (Cmin) |
Time Frame: | Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Progression-Free Survival (PFS) for Dose Expansion |
Time Frame: | Baseline to measured progressive disease (up to 24 months) |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DR) for Dose Expansion |
Time Frame: | Baseline up to approximately 24 months |
Safety Issue: | |
Description: | |
Measure: | Change from baseline of immune cells from tumor biopsies |
Time Frame: | Baseline and Cycle 2, Day 1 (each cycle is 28 days) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Pfizer |
Trial Keywords
- Gastric cancer
- Esophageal cancer
- Colorectal cancer
- Advanced esophageal cancer
- Metastatic esophageal cancer
- Advanced colorectal cancer
- Metastatic gastric cancer
- Advanced gastric cancer
- Metastatic colorectal cancer
- GUCY2c
- Anti-PD1
- Anti-VEGF
- Measurable disease
- PF-07062119
- PF-06801591
- Bevacizumab
Last Updated
June 16, 2021