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

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

  • Neoplasm Metastasis

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