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

NOT ENROLLING
Protocol # :
20-465
Conditions
Neoplasm Metastasis
Phase
I
Disease Sites
Healthy volunteer
Transplanted organ and tissue status, unspecified
Disease not specified
Neuroendocrine/Carcinoid
Gastroesophageal Junction
Gallbladder/Biliary
Other specified personal risk factors, not elsewhere classified
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Donors
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Awad, Mark
Site Research Nurses
Aspinwall, Sheridan
Becker, Simone
Hurley, Meaghan
Janell, Samantha
Kelley, Elaine
Lam, Ethan
Souza, Joseph
Sullivan, Molly, O'Brien

Trial Description

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

Eligibility Requirements

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.

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