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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Dose escalation and expansion
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
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: PF-07265807
    Given 2 weeks on/1 week off
    Other names:
    • ARRY-067
  • Drug: Sasanlimab
    Given SC Q3W
    Other names:
    • PF-06801591; RN-888
  • Drug: Axitinib
    Dosed per package label starting with 5 mg PO BID
    Other names:
    • AG-013736; Inlyta
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: PF-07265807
    Given 2 weeks on/1 week off
    Other names:
    • ARRY-067
  • Drug: Sasanlimab
    Given SC Q3W
    Other names:
    • PF-06801591; RN-888
  • Drug: Axitinib
    Dosed per package label starting with 5 mg PO BID
    Other names:
    • AG-013736; Inlyta

More Details

Status
Active, not recruiting
Sponsor
Pfizer

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.