Description:
First-in-human study to assess safety, tolerability, PK, and preliminary activity of
PF-07265807 in participants with selected advanced or metastatic solid tumors.
Title
- Brief Title: A Study of PF-07265807 In Participants With Advanced or Metastatic Solid Tumors
- Official Title: A PHASE 1, OPEN-LABEL, MULTI-CENTER, DOSE-FINDING, PHARMACOKINETIC, SAFETY AND TOLERABILITY STUDY OF PF-07265807 IN PARTICIPANTS WITH SELECTED ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES
Clinical Trial IDs
- ORG STUDY ID:
C4201002
- SECONDARY ID:
ARRAY-067-102
- NCT ID:
NCT04458259
Conditions
Interventions
Drug | Synonyms | Arms |
---|
PF-07265807 | | Dose Level 1 |
PF-07265807 | | Dose Level 2 |
PF-07265807 | | Dose Level 3 |
PF-07265807 | | Dose Level 4 |
PF-07265807 | | Dose Level 5 |
Purpose
First-in-human study to assess safety, tolerability, PK, and preliminary activity of
PF-07265807 in participants with selected advanced or metastatic solid tumors.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Level 1 | Experimental | Participants will receive PF-07265807 at 25 mg once a day (QD) 2 weeks on/1 week off | |
Dose Level 2 | Experimental | Participants will receive PF-07265807 at 50 mg QD 2 weeks on/1 week off | |
Dose Level 3 | Experimental | Participants will receive PF-07265807 at 100 mg QD 2 weeks on/1 week off | |
Dose Level 4 | Experimental | Participants will receive PF-07265807 at 200 mg QD 2 weeks on/1 week off | |
Dose Level 5 | Experimental | Participants will receive PF-07265807 at 300 mg QD 2 weeks on/1 week off | |
Eligibility Criteria
Inclusion Criteria:
- Participants who are intolerant or resistant to standard treatment for selected solid
tumors
- at least one measurable or non-measurable lesion, not previously irradiated, as
defined by RECIST 1.1
- ECOG Performance Status 0 or 1, 2 with approval
- Adequate Bone Marrow Function
- Adequate Renal Function
- Adequate Liver Function
- Resolved acute effects of any prior therapy
Exclusion Criteria:
- Known active uncontrolled or symptomatic CNS metastases
- Major surgery within 6 weeks, radiation therapy within 4 weeks, systemic anti-cancer
therapy within 2 week or 5 half-lives (4 weeks or 5 half-lives for antibody therapies
or investigational drug(s) taken on another study) prior to study entry
- Active or history of autoimmune disease requiring >10mg/day prednisone or other
concurrent immunosuppressive therapy
- Active, uncontrolled infection (controlled HBV, HCV, HIV/AIDS may be allowed) as
defined in protocol
- Retinal or other serious ophthalmic disorders as defined in protocol
- Clinically significant cardiac disease as defined in protocol
- Inability to consume or absorb study drug
- Known or suspected hypersensitivity to PF-07265807
- Prohibited concomitant medications as defined in protocol
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 (DLTs) |
Time Frame: | Baseline through day 42 |
Safety Issue: | |
Description: | DLTs will be evaluated during the first two cycles (day 42). The number of DLTs will be used to determine the maximum tolerated dose (MTD) |
Secondary Outcome Measures
Measure: | Pharmacokinetic Parameters |
Time Frame: | Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose |
Safety Issue: | |
Description: | Single dose PK will be calculated including Maximum Observed Plasma Concentration (Cmax) |
Measure: | Pharmacokinetic Parameters |
Time Frame: | Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose |
Safety Issue: | |
Description: | Single dose PK will be calculated including time to reach Maximum Observed Plasma Concentration (Tmax) |
Measure: | Pharmacokinetic Parameters |
Time Frame: | Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose |
Safety Issue: | |
Description: | Single dose PK will be calculated including Area Under the Curve from time 0 to the last sampling time point within the dose interval (AUClast) |
Measure: | Pharmacokinetic Parameters |
Time Frame: | Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose |
Safety Issue: | |
Description: | Single dose PK will be calculated including, as data permit, terminal elimination half life (t1/2) |
Measure: | Pharmacokinetic Parameters |
Time Frame: | Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose |
Safety Issue: | |
Description: | Single dose PK will be calculated including, as data permit, Area Under the Curve from time 0 extrapolated to infinity (AUCinf) |
Measure: | Pharmacokinetic Parameters |
Time Frame: | Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose |
Safety Issue: | |
Description: | Single dose PK will be calculated including, as data permit, Area Under the Curve from the time of dose to the time of the subsequent dose (AUCtau) |
Measure: | Pharmacokinetic Parameters |
Time Frame: | Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose |
Safety Issue: | |
Description: | Single dose PK will be calculated including, as data permit, apparent oral plasma clearance (CL/F) |
Measure: | Pharmacokinetic Parameters |
Time Frame: | Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose |
Safety Issue: | |
Description: | Single dose PK will be calculated including, as data permit, apparent volume of distribution (Vz/F) |
Measure: | Pharmacokinetic Parameters |
Time Frame: | Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose |
Safety Issue: | |
Description: | Multiple dose PK will be calculated including Maximum Observed Steady State Plasma Concentration (Css,max) |
Measure: | Pharmacokinetic Parameters |
Time Frame: | Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose |
Safety Issue: | |
Description: | Multiple dose PK will be calculated including Time to reach Maximum Observed Steady State Plasma Concentration (Tss,max) |
Measure: | Pharmacokinetic Parameters |
Time Frame: | Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose |
Safety Issue: | |
Description: | Multiple dose PK will be calculated including Area Under the Curve from the time of dose to the time of the subsequent dose at steady state (AUCss,tau) |
Measure: | Pharmacokinetic Parameters |
Time Frame: | Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose |
Safety Issue: | |
Description: | Multiple dose PK will be calculated including, as data permit, apparent oral plasma clearance (CL/F) |
Measure: | Pharmacokinetic Parameters |
Time Frame: | Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose |
Safety Issue: | |
Description: | Multiple dose PK will be calculated including, as data permit, apparent volume of distribution at steady state (Vss/F) |
Measure: | Pharmacokinetic Parameters |
Time Frame: | Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose |
Safety Issue: | |
Description: | Multiple dose PK will be calculated including, as data permit, accumulation ratio (Rac) |
Measure: | Objective Response Rate |
Time Frame: | Baseline through up to 24 months |
Safety Issue: | |
Description: | Tumor response as assessed using RECIST 1.1 |
Measure: | Duration of Response (DOR) |
Time Frame: | Baseline through up to 24 months |
Safety Issue: | |
Description: | Duration of response as assessed using RECIST 1.1 |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Pfizer |
Trial Keywords
- TAMK (TAM kinase)
- MER (mer proto-oncogene)
- MERTK (mer proto-oncogene tyrosine kinase)
- AXL (AXL receptor tyrosine kinase)
- AXL/MER
- selective kinase inhibitor
- PD-1 (programmed cell death protein 1)
- PD-L1 (programmed cell death ligand 1)
- immune modulator
Last Updated
May 11, 2021