Study of PF-07265807 in Participants With Metastatic Solid Tumors.

June 3, 2026 updated by: Pfizer

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

A First-in-Human Pharmacokinetic, Safety, and Tolerability Study of PF-07265807 as Monotherapy and in Combination in Participants with Advanced or Metastatic Solid Tumors

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network
  • Italy
      • Naples, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
    • ROME
      • Roma, ROME, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore
  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro
  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group
      • Fayetteville, Arkansas, United States, 72703
        • Henry Eye Clinic
      • Rogers, Arkansas, United States, 72758
        • Highlands Oncology Group
      • Springdale, Arkansas, United States, 72762
        • Highlands Oncology Group
    • California
      • Orange, California, United States, 92868
        • UCI Chao Family Comprehensive Cancer Center
      • San Francisco, California, United States, 94158
        • UCSF Helen Diller Family Comprehensive Cancer Center
      • San Francisco, California, United States, 94158
        • Clinical & Translational Science Institute
      • San Francisco, California, United States, 94158
        • UCSF Helen Diller Family Comprehensive Cancer Center - Mission Hall
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Rocky Mountain Lions Eye Institute (RMLEI)
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Community Health Network, Inc.
      • Indianapolis, Indiana, United States, 46250
        • Community Health Network Cancer Center North
      • Indianapolis, Indiana, United States, 46219
        • Community Health Network, Inc.
      • Indianapolis, Indiana, United States, 46227
        • Community Health Network, Inc.
      • Indianapolis, Indiana, United States, 46256
        • Community Health Network, Inc.
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
      • Newton, Massachusetts, United States, 02459
        • Dana-Farber Cancer Institute - Chestnut Hill
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Hackensack, New Jersey, United States, 07601
        • John Theurer Cancer Center at Hackensack University Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Eye Center
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center, lnvestigational Chemotherapy Service
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas M. D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least one measurable (Parts 1-4) or non-measurable lesion (Parts 1-3), 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
  • Able to provide adequate archival tumor tissue or freshly obtained tumor tissue (some participants will require mandatory pre- and on-treatment biopsy is part of the biomarker cohort).
  • Life expectancy of at least 3 months.
  • Part 1 and Part 2: Participants who are intolerant or resistant to standard treatment for selected solid tumors.
  • Part 3: Participants with advanced/metastatic RCC with a clear cell component and progressed with no standard therapy available.
  • Part 4, Cohort 1: Participants with NSCLC with METex14-skipping alteration(s) and progressed on at least 1 prior therapy.
  • Part 4, Cohort 2: Participants with MSS CRC with intermediate TMB and progressed with no satisfactory alternative treatment available, but has not received prior treatment with an anti-PD-(L)1 therapy.
  • Part 4, Cohort 3: Participants with metastatic gastric or GEJ adenocarcinoma that is PD-L1 positive that has progressed on at least 2 but no more than 3 prior chemotherapy regiments, but has not received prior treatment with an anti-PD-(L)1 therapy.
  • Part 4, Cohort 4: Participants with metastatic RCC with a clear cell component with IMDC intermediate or poor risk that have not received any prior systemic therapy for metastatic disease.

Exclusion Criteria:

  • Known active uncontrolled or symptomatic CNS metastases.
  • Any other active malignancy within 2 years prior to enrollment.
  • 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.
  • Uncontrolled HTN that cannot be controlled by medications.
  • Inability to consume or absorb study drug.
  • Known or suspected hypersensitivity to PF-07265807.
  • Prohibited concomitant medications as defined in protocol.
  • Active inflammatory GI disease, uncontrollable chronic diarrhea, or previous gastric resection or lap band surgery affecting absorption.
  • Active bleeding disorder.
  • Discontinuation of prior checkpoint inhibitor for treatment-related toxicity.
  • Experienced >= G3 treatment-related irAE with prior PD-(L)1 agent.
  • Prior treatment with selective AXL/MERTK inhibitors

For participants receiving sasanlimab:

- Known history of non-infectious pneumonitis that required steroid treatment or current pneumonitis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Monotherapy Dose Escalation: Part 1
Monotherapy dose escalation of PF-07265807 in participants with select tumor types.
Drug: PF-07265807
Given 2 weeks on/1 week off
Other Names:
  • ARRY-067
Experimental: Doublet Dose Escalation: Part 2
Doublet combination dose escalation of PF-07265807 with sasanlimab in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant.
Drug: PF-07265807
Given 2 weeks on/1 week off
Other Names:
  • ARRY-067
Drug: Sasanlimab
Given SC Q3W
Other Names:
  • PF-06801591; RN-888
Experimental: Expansion Phase: Part 4, Cohort 1
PF-07265807 monotherapy in participants with METex14 mutant NSCLC.
Drug: PF-07265807
Given 2 weeks on/1 week off
Other Names:
  • ARRY-067
Experimental: Expansion Phase: Part 4, Cohort 2
PF-07265807 with sasanlimab in participants with MSS CRC
Drug: PF-07265807
Given 2 weeks on/1 week off
Other Names:
  • ARRY-067
Drug: Sasanlimab
Given SC Q3W
Other Names:
  • PF-06801591; RN-888
Experimental: Expansion Phase: Part 4, Cohort 3
PF-07265807 with sasanlimab in participants with PD-L1+ gastric cancer/GEJ
Drug: PF-07265807
Given 2 weeks on/1 week off
Other Names:
  • ARRY-067
Drug: Sasanlimab
Given SC Q3W
Other Names:
  • PF-06801591; RN-888
Experimental: Expansion Phase: Part 4, Cohort 4
PF-07265807 with sasanlimab plus axitinib in participants with RCC
Drug: Axitinib
Dosed per package label starting with 5 mg PO BID
Other Names:
  • AG-013736; Inlyta
Drug: PF-07265807
Given 2 weeks on/1 week off
Other Names:
  • ARRY-067
Drug: Sasanlimab
Given SC Q3W
Other Names:
  • PF-06801591; RN-888
Experimental: Triplet Dose Escalation: Part 3
Triplet combination dose escalation of PF-07265807 with sasanlimab plus axitinib in participants with select tumor types. PF-07265807 will dose escalate. Sasanlimab dose will stay constant. Axitinib dose will follow label.
Drug: Axitinib
Dosed per package label starting with 5 mg PO BID
Other Names:
  • AG-013736; Inlyta
Drug: PF-07265807
Given 2 weeks on/1 week off
Other Names:
  • ARRY-067
Drug: Sasanlimab
Given SC Q3W
Other Names:
  • PF-06801591; RN-888

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parts 1, 2, and 3: Number of participants with dose limiting toxicities (DLTs)
Time Frame: Baseline through day 21 or 42
DLTs will be evaluated during the first cycle (day 21) or two cycles (day 42). The number of DLTs will be used to determine the maximum tolerated dose (MTD)
Baseline through day 21 or 42
Parts 1, 2 and 3: Number of participants with treatment emergent adverse events (AEs)
Time Frame: Baseline through approximately 2 years
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Baseline through approximately 2 years
Parts 1, 2, and 3: Number of participants with laboratory abnormalities
Time Frame: Baseline through approximately 2 years
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Baseline through approximately 2 years
Part 4: Overall Response Rate (ORR)
Time Frame: Baseline through approximately 2 years
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Baseline through approximately 2 years
Part 4, Cohort 4: Complete Response (CR)
Time Frame: Baseline through approximately 2 years
Response will be evaluated via radiographical tumor assessment by RECIST v1.1
Baseline through approximately 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parts 1, 2, and 3: Maximum plasma concentration (Cmax) of PF-07265807 and its metabolite
Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Single dose (Cmax) and multiple dose (assuming steady state is achieved; Cmax,ss) pharmacokinetic (PK) parameters of PF-07265807 and its metabolite
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Maximum plasma concentration (Cmax) of sasanlimab
Time Frame: Through study completion, an average of 1 year
Single dose (Cmax) pharmacokinetic (PK) parameters of sasanlimab
Through study completion, an average of 1 year
Part 3: Maximum plasma concentration at steady state (Cmax,ss) of axitinib
Time Frame: Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Multiple dose (assuming steady state is achieved; Cmax,ss) pharmacokinetic (PK) parameters of axitinib
Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Parts 1, 2, and 3: Time to reach maximum plasma concentration (Tmax) of PF-07265807 and its metabolite
Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Single dose (Tmax) and multiple dose (assuming steady state is achieved; Tmax,ss) pharmacokinetic parameters of PF-07265807 and its metabolite
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Time to reach maximum plasma concentration (Tmax) of sasanlimab
Time Frame: Through study completion, an average of 1 year
Single dose (Tmax) pharmacokinetic parameters of sasanlimab
Through study completion, an average of 1 year
Part 3: Time to reach maximum plasma concentration at steady state (Tmax,ss) of axitinib
Time Frame: Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Multiple dose (assuming steady state is achieved; Tmax,ss) pharmacokinetic parameters of axitinib
Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Parts 1, 2, and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of PF-07265807 and its metabolite
Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Single dose (AUClast) pharmacokinetic parameters of PF-07265807 and its metabolite
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Area under the curve from the time of dose to the last measurable concentration (AUClast) of sasanlimab
Time Frame: Through study completion, an average of 1 year
Single dose (AUClast) pharmacokinetic parameters of sasanlimab
Through study completion, an average of 1 year
Parts 1, 2, and 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of PF-07265807 and its metabolite
Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Multiple dose assuming steady state is achieved (AUCtau,ss) pharmacokinetic parameters of PF-07265807 and its metabolite
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Part 3: Area under the curve from the time of dose to the time of the subsequent dose (AUCtau) at steady state of axitinib
Time Frame: Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Multiple dose assuming steady state is achieved (AUCtau,ss) pharmacokinetic parameters of axitinib
Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 0.5,1,2,4, and 8 hours post dose
Parts 1, 2, and 3: Terminal elimination half-life (t1/2) of PF-07265807 and its metabolite
Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
As data permits, single dose (t1/2) pharmacokinetic parameters of PF-07265807 and its metabolite
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Terminal elimination half-life (t1/2) of sasanlimab
Time Frame: Through study completion, an average of 1 year
As data permits, single dose (t1/2) pharmacokinetic parameters of sasanlimab
Through study completion, an average of 1 year
Parts 1, 2, and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of PF-07265807 and its metabolite
Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
As data permits, single dose (AUCinf) pharmacokinetic parameters of PF-07265807 and its metabolite
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Area under the curve from the time of dose extrapolated to infinity (AUCinf) of sasanlimab
Time Frame: Through study completion, an average of 1 year
As data permits, single dose (AUCinf) pharmacokinetic parameters of sasanlimab
Through study completion, an average of 1 year
Parts 1, 2, and 3: Apparent oral clearance (CL/F) of PF-07265807
Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
As data permits, single dose (CL/F) and multiple dose pharmacokinetic parameters of PF-07265807
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Apparent clearance (CL/F) of sasanlimab
Time Frame: Through study completion, an average of 1 year
As data permits, single dose (CL/F) pharmacokinetic parameters of sasanlimab
Through study completion, an average of 1 year
Parts 1, 2, and 3: Apparent terminal volume of distribution (Vz/F) of PF-07265807
Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
As data permits, single dose (Vz/F) and multiple dose (Vss/F) pharmacokinetic parameters of PF-07265807
Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 (if daily dosing) hours post dose; Cycle 1 Day 7, Cycle 2 Days 1 and 14 predose and 2 hours post dose; Cycle 3 Days 1 and 14 predose
Parts 2 and 3: Apparent terminal volume of distribution (Vz/F) of sasanlimab
Time Frame: Through study completion, an average of 1 year
As data permits, single dose (Vz/F) pharmacokinetic parameters of sasanlimab
Through study completion, an average of 1 year
Parts 1, 2, and 3: ORR
Time Frame: Baseline through approximately 2 years
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Baseline through approximately 2 years
Part 4: Number of participants with treatment emergent AEs
Time Frame: Baseline through approximately 2 years
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Baseline through approximately 2 years
Part 4: Number of participants with laboratory abnormalities
Time Frame: Baseline through approximately 2 years
Laboratory abnormalities as characterized by type, frequency, severity, and timing
Baseline through approximately 2 years
Part 4: Trough concentration (Ctrough) of PF-07265807 and its metabolite
Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14 predose, 2, 4 hours post dose; Cycle 1 Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14 predose
Predose (Ctrough) pharmacokinetic (PK) parameter of PF-07265807 and its metabolite
Each cycle is 21 days. Cycle 1 Days 1 and 14 predose, 2, 4 hours post dose; Cycle 1 Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14 predose
Part 4: Post dose concentration (Cmax) of PF-07265807 and its metabolite
Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14 predose, 2, 4 hours post dose; Cycle 1 Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14 predose
Post dose (Cmax) pharmacokinetic (PK) parameter of PF-07265807 and its metabolite
Each cycle is 21 days. Cycle 1 Days 1 and 14 predose, 2, 4 hours post dose; Cycle 1 Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14 predose
Part 4, Cohorts 2, 3 and 4: Trough concentration (Ctrough) of sasanlimab
Time Frame: Each cycle is 21 days. Cycle 1 Days 1, 7, and 14, Cycle 2 Day 1, Cycle 7 Day 1, and every 6 cycles thereafter predose
Predose (Ctrough) pharmacokinetic (PK) parameter of sasanlimab
Each cycle is 21 days. Cycle 1 Days 1, 7, and 14, Cycle 2 Day 1, Cycle 7 Day 1, and every 6 cycles thereafter predose
Part 4, Cohort 4: Trough concentration (Ctrough) of axitinib
Time Frame: Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 2, and 4 hours post dose
Predose (Ctrough) pharmacokinetic (PK) parameter of axitinib
Each cycle is 21 days. Cycle 1 Day 1 predose; Cycle 1 Day 14 predose, 2, and 4 hours post dose
Parts 2, 3, and 4 Cohorts 2-4: Immunogenicity of sasanlimab when given in combination
Time Frame: Through study completion, an average of 1 year
Incidence and titer of anti-sasanlimab ADA response
Through study completion, an average of 1 year
Duration of Response
Time Frame: Baseline through approximately 2 years
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Baseline through approximately 2 years
Disease Control Rate
Time Frame: Baseline through approximately 2 years
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Baseline through approximately 2 years
Progression Free Survival
Time Frame: Baseline through approximately 2 years
Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Baseline through approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 24, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C4201002
  • ARRAY-067-102 (Other Identifier: Alias Study Number)
  • 2021-004270-59 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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