PF-07265028 As Single Agent And In Combination With Sasanlimab in Advanced or Metastatic Solid Tumors
NCT05233436 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2026-02-19
Summary
The purpose of this study is to assess the safety and effects of PF-07265028 as monotherapy and in combination with sasanlimab.
The study aims to identify the maximum tolerated dose (MTD) of PF-07265028 as monotherapy; evaluate the clinical activity of monotherapy and combination; and select the recommended dose of PF-07265028 monotherapy and in combination for potential further studies and development.
The study contains 2 parts, Dose Escalation (Part 1) to determine the recommended dose of PF-07265028 as single agent and in combination, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.
It is expected that most participants will take part in this study for up to 1 year with six on-site visits in the first month and then at least twice every subsequent month while they are on treatment.
Conditions
- Advanced Solid Tumors
- Gastric Cancer
- Gastroesophageal Junction Cancer
- Urothelial Cancer
- Non Small Cell Lung Cancer
- Head and Neck Squamous Cell Carcinomas
Interventions
- DRUG
-
PF-07265028
PF-07265028 will be administered orally
- BIOLOGICAL
-
Administered subcutaneously
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-24
- Primary Completion
- 2023-10-16
- Completion
- 2023-10-16
- FDA Drug
- Yes
Countries
- United States
- Japan
Study Locations
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