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Spots Global Cancer Trial Database for PF-07265028 As Single Agent And In Combination With Sasanlimab in Advanced or Metastatic Solid Tumors

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Trial Identification

Brief Title: PF-07265028 As Single Agent And In Combination With Sasanlimab in Advanced or Metastatic Solid Tumors

Official Title: A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF PF-07265028 AS A SINGLE AGENT AND IN COMBINATION WITH SASANLIMAB EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07265028 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS

Study ID: NCT05233436

Study Description

Brief 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.

Detailed Description: The purpose of this first-in-human study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of increasing doses of PF-07265028 as monotherapy and in combination with sasanlimab; identify the maximum tolerated dose (MTD) of PF-07265028 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

HonorHealth Research Institute, Scottsdale, Arizona, United States

HonorHealth Scottsdale Shea Medical Center, Scottsdale, Arizona, United States

D&H Cancer Research Center LLC, Margate, Florida, United States

Napa Research, Margate, Florida, United States

University of Iowa, Iowa City, Iowa, United States

START Midwest, Grand Rapids, Michigan, United States

Mary Crowley Cancer Research - Medical City Hospital, Dallas, Texas, United States

Mary Crowley Cancer Research, Dallas, Texas, United States

South Texas Accelerated Research Therapeutics (START), San Antonio, Texas, United States

South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States

National Cancer Center Hospital East, Kashiwa, Chiba, Japan

The Cancer Institute Hospital of JFCR, Koto, Tokyo, Japan

Contact Details

Name: Pfizer CT.gov Call Center

Affiliation: Pfizer

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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