Clinical Trials /

A Study of PF-07265807 In Participants With Advanced or Metastatic Solid Tumors

NCT04458259

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

  • Neoplasm Metastasis

Interventions

DrugSynonymsArms
PF-07265807Dose Level 1
PF-07265807Dose Level 2
PF-07265807Dose Level 3
PF-07265807Dose Level 4
PF-07265807Dose 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

NameTypeDescriptionInterventions
Dose Level 1ExperimentalParticipants will receive PF-07265807 at 25 mg once a day (QD) 2 weeks on/1 week off
  • PF-07265807
Dose Level 2ExperimentalParticipants will receive PF-07265807 at 50 mg QD 2 weeks on/1 week off
  • PF-07265807
Dose Level 3ExperimentalParticipants will receive PF-07265807 at 100 mg QD 2 weeks on/1 week off
  • PF-07265807
Dose Level 4ExperimentalParticipants will receive PF-07265807 at 200 mg QD 2 weeks on/1 week off
  • PF-07265807
Dose Level 5ExperimentalParticipants will receive PF-07265807 at 300 mg QD 2 weeks on/1 week off
  • PF-07265807

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

March 3, 2021