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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-24

Study Completion Date

2024-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of PF-07263689 in Participants With Selected Advanced Solid Tumors

NCT05061537

Renal Cell Cancer Melanoma Non-Small-Cell Lung Cancer +7 more

TERMINATED PHASE1

A Study in Advanced/Metastatic Solid Tumors With the Study Medicine (PF-07329640) When Given Alone or In Combination

NCT06448364

Advanced or Metastatic Solid Tumors Non-Small Cell Lung Cancer Colorectal Cancer +2 more

TERMINATED PHASE1

A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors

NCT06285097

Neoplasms Non-small-cell Lung Cancer Melanoma +5 more

TERMINATED PHASE1

A Study Of PF-06647263 In Patients With Advanced Solid Tumors

NCT02078752

Neoplasms Triple-Negative Breast Cancer

TERMINATED PHASE1

A Study to Learn About How Different Amounts of the Study Medicine PF-07826390 Act in the Body of People With Cancer When Taken Alone or With Other Anti-cancer Medicines.

NCT06546553

Neoplasms Non-small-cell Lung Cancer Squamous Cell Carcinoma of the Head and Neck +3 more

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasm Metastasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Dose escalation and expansion

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Monotherapy Dose Escalation: Part 1

Monotherapy dose escalation of PF-07265807 in participants with select tumor types.

Group Type EXPERIMENTAL

PF-07265807

Intervention Type DRUG

Given 2 weeks on/1 week off

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.

Group Type EXPERIMENTAL

PF-07265807

Intervention Type DRUG

Given 2 weeks on/1 week off

Sasanlimab

Intervention Type DRUG

Given SC Q3W

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.

Group Type EXPERIMENTAL

PF-07265807

Intervention Type DRUG

Given 2 weeks on/1 week off

Sasanlimab

Intervention Type DRUG

Given SC Q3W

Axitinib

Intervention Type DRUG

Dosed per package label starting with 5 mg PO BID

Expansion Phase: Part 4, Cohort 1

PF-07265807 monotherapy in participants with METex14 mutant NSCLC.

Group Type EXPERIMENTAL

PF-07265807

Intervention Type DRUG

Given 2 weeks on/1 week off

Expansion Phase: Part 4, Cohort 2

PF-07265807 with sasanlimab in participants with MSS CRC

Group Type EXPERIMENTAL

PF-07265807

Intervention Type DRUG

Given 2 weeks on/1 week off

Sasanlimab

Intervention Type DRUG

Given SC Q3W

Expansion Phase: Part 4, Cohort 3

PF-07265807 with sasanlimab in participants with PD-L1+ gastric cancer/GEJ

Group Type EXPERIMENTAL

PF-07265807

Intervention Type DRUG

Given 2 weeks on/1 week off

Sasanlimab

Intervention Type DRUG

Given SC Q3W

Expansion Phase: Part 4, Cohort 4

PF-07265807 with sasanlimab plus axitinib in participants with RCC

Group Type EXPERIMENTAL

PF-07265807

Intervention Type DRUG

Given 2 weeks on/1 week off

Sasanlimab

Intervention Type DRUG

Given SC Q3W

Axitinib

Intervention Type DRUG

Dosed per package label starting with 5 mg PO BID

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-07265807

Given 2 weeks on/1 week off

Intervention Type DRUG

Sasanlimab

Given SC Q3W

Intervention Type DRUG

Axitinib

Dosed per package label starting with 5 mg PO BID

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ARRY-067 PF-06801591; RN-888 AG-013736; Inlyta

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Henry Eye Clinic

Fayetteville, Arkansas, United States

Site Status

Highlands Oncology Group

Fayetteville, Arkansas, United States

Site Status

Highlands Oncology Group

Rogers, Arkansas, United States

Site Status

Highlands Oncology Group

Springdale, Arkansas, United States

Site Status

UCI Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status

Clinical & Translational Science Institute

San Francisco, California, United States

Site Status

UCSF Helen Diller Family Comprehensive Cancer Center - Mission Hall

San Francisco, California, United States

Site Status

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Site Status

Rocky Mountain Lions Eye Institute (RMLEI)

Aurora, Colorado, United States

Site Status

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, United States

Site Status

University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

Aurora, Colorado, United States

Site Status