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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04458259
Recruitment Status : Active, not recruiting
First Posted : July 7, 2020
Last Update Posted : April 3, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 24, 2020
First Posted Date  ICMJE July 7, 2020
Last Update Posted Date April 3, 2024
Actual Study Start Date  ICMJE September 24, 2020
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2022)
  • 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)
  • 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
  • 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.
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2020)
  • Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Baseline through day 42 ]
    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)
  • 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
  • Number of participants with laboratory abnormalities [ Time Frame: Baseline through approximately 2 years ]
    Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2022)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Duration of Response [ Time Frame: Baseline through approximately 2 years ]
    Response will be evaluable via radiographical tumor assessment by RECIST v1.1
  • Disease Control Rate [ Time Frame: Baseline through approximately 2 years ]
    Response will be evaluable via radiographical tumor assessment by RECIST v1.1
  • Progression Free Survival [ Time Frame: Baseline through approximately 2 years ]
    Response will be evaluable via radiographical tumor assessment by RECIST v1.1
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2020)
  • 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 ]
    Single dose PK will be calculated including Maximum Observed Plasma Concentration (Cmax)
  • 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 ]
    Single dose PK will be calculated including time to reach Maximum Observed Plasma Concentration (Tmax)
  • 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 ]
    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)
  • 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 ]
    Single dose PK will be calculated including, as data permit, terminal elimination half life (t1/2)
  • 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 ]
    Single dose PK will be calculated including, as data permit, Area Under the Curve from time 0 extrapolated to infinity (AUCinf)
  • 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 ]
    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)
  • 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 ]
    Single dose PK will be calculated including, as data permit, apparent oral plasma clearance (CL/F)
  • 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 ]
    Single dose PK will be calculated including, as data permit, apparent volume of distribution (Vz/F)
  • 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 ]
    Multiple dose PK will be calculated including Maximum Observed Steady State Plasma Concentration (Css,max)
  • 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 ]
    Multiple dose PK will be calculated including Time to reach Maximum Observed Steady State Plasma Concentration (Tss,max)
  • 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 ]
    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)
  • 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 ]
    Multiple dose PK will be calculated including, as data permit, apparent oral plasma clearance (CL/F)
  • 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 ]
    Multiple dose PK will be calculated including, as data permit, apparent volume of distribution at steady state (Vss/F)
  • 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 ]
    Multiple dose PK will be calculated including, as data permit, accumulation ratio (Rac)
  • Objective Response Rate [ Time Frame: Baseline through up to 24 months ]
    Tumor response as assessed using RECIST 1.1
  • Duration of Response (DOR) [ Time Frame: Baseline through up to 24 months ]
    Duration of response as assessed using RECIST 1.1
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of PF-07265807 in Participants With Metastatic Solid Tumors.
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Dose escalation and expansion
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasm Metastasis
Intervention  ICMJE
  • Drug: PF-07265807
    Given 2 weeks on/1 week off
    Other Name: ARRY-067
  • Drug: Sasanlimab
    Given SC Q3W
    Other Name: PF-06801591; RN-888
  • Drug: Axitinib
    Dosed per package label starting with 5 mg PO BID
    Other Name: AG-013736; Inlyta
Study Arms  ICMJE
  • Experimental: Monotherapy Dose Escalation: Part 1
    Monotherapy dose escalation of PF-07265807 in participants with select tumor types.
    Intervention: Drug: PF-07265807
  • 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.
    Interventions:
    • Drug: PF-07265807
    • Drug: Sasanlimab
  • 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.
    Interventions:
    • Drug: PF-07265807
    • Drug: Sasanlimab
    • Drug: Axitinib
  • Experimental: Expansion Phase: Part 4, Cohort 1
    PF-07265807 monotherapy in participants with METex14 mutant NSCLC.
    Intervention: Drug: PF-07265807
  • Experimental: Expansion Phase: Part 4, Cohort 2
    PF-07265807 with sasanlimab in participants with MSS CRC
    Interventions:
    • Drug: PF-07265807
    • Drug: Sasanlimab
  • Experimental: Expansion Phase: Part 4, Cohort 3
    PF-07265807 with sasanlimab in participants with PD-L1+ gastric cancer/GEJ
    Interventions:
    • Drug: PF-07265807
    • Drug: Sasanlimab
  • Experimental: Expansion Phase: Part 4, Cohort 4
    PF-07265807 with sasanlimab plus axitinib in participants with RCC
    Interventions:
    • Drug: PF-07265807
    • Drug: Sasanlimab
    • Drug: Axitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 20, 2023)		 67
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2020)		 37
Estimated Study Completion Date  ICMJE June 30, 2024
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   China,   Italy,   Japan,   Korea, Republic of,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04458259
Other Study ID Numbers  ICMJE C4201002
ARRAY-067-102 ( Other Identifier: Alias Study Number )
2021-004270-59 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.
Current Responsible Party Pfizer
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP