Esophageal Cancer Clinical Trial
Study of PF-07265807 in Participants With Metastatic Solid Tumors.
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
Eligibility Criteria
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 immunotherapy-drugs-are-boosting-survival/" >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.
For Part 2, Part 3, and Part 4, Cohorts 2-4:
- Known history of non-infectious pneumonitis that required steroid treatment or current pneumonitis.
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There are 32 Locations for this study
Fayetteville Arkansas, 72703, United States
Fayetteville Arkansas, 72703, United States
Rogers Arkansas, 72758, United States
Springdale Arkansas, 72762, United States
Orange California, 92868, United States
Orange California, 92868, United States
San Francisco California, 94158, United States
San Francisco California, 94158, United States
San Francisco California, 94158, United States
San Francisco California, 94158, United States
Aurora Colorado, 80045, United States
Aurora Colorado, 80045, United States
Aurora Colorado, 80045, United States
Aurora Colorado, 80045, United States
Indianapolis Indiana, 46219, United States
Indianapolis Indiana, 46227, United States
Indianapolis Indiana, 46250, United States
Indianapolis Indiana, 46250, United States
Indianapolis Indiana, 46250, United States
Indianapolis Indiana, 46256, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Hackensack New Jersey, 07601, United States
Hackensack New Jersey, 07601, United States
Durham North Carolina, 27705, United States
Durham North Carolina, 27710, United States
Houston Texas, 77030, United States
Macquarie University New South Wales, 2109, Australia
Waratah New South Wales, 2298, Australia
Edmonton Alberta, T6G 1, Canada
Hamilton Ontario, L8V5C, Canada
Toronto Ontario, M5G 2, Canada
Quebec City Quebec, G1J 1, Canada
Québec Quebec, G1R 2, Canada
Guangzhou Guangdong, 51012, China
Roma Rome, 00168, Italy
Milano , 20141, Italy
Napoli , 80131, Italy
Roma , 00168, Italy
Kashiwa Chiba, 277-8, Japan
Barcelona , 08035, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Valencia , 46010, Spain
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