Life sciences · Phase 1 Trial
ClinicalTrials.gov · November 5, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT07318805). This is a study registration, not published results. Lead sponsor: Pfizer. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 260 participants (ESTIMATED). Conditions: Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Colorectal Cancer, Metastatic Colorectal Adenocarcinoma, Triple Negative Breast Cancer. Interventions: DRUG: PF-08032562; DRUG: Fulvestrant; DRUG: Cetuximab; DRUG: Fluorouracil; DRUG: Oxaliplatin; DRUG: Leucovorin; DRUG: Bevacizumab. Primary outcome measures: Part 1 (Dose Escalation): Number of participants with Dose-Limiting Toxicities (DLT) , Baseline up to 28 days; Part 1 (Dose Escalation): Number of participants with laboratory abnormalities , From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first; Part 1 (Dose Escalation): Incidence of Adverse Events (AEs) , From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first; Part 2 (Dose Expansion): Objective Response Rate (ORR) , Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years). Brief summary: The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer. This study also aims to find the best amount of study medication. This study is seeking participants that have advanced or metastatic breast cancer (BC), or advanced or metastatic colorectal cancer (CRC). All participants in this study will take the study medication (PF-08032562) as pill by mouth. This will be repeated for 28-day cycles. Depending on which part of the study participants are enrolled into, they will receive the study medication PF-08032562 alone or in combination with other anti-cancer medications. The study medication (PF-08032562) will be taken by mouth (PO) in combination with other anti-cancer medications given in the study clinic by intramuscular (IM) injection into the muscle or intravenous (IV) infusion that is directly injected into the veins at different times (depending on the treatment) during the 28-day cycle. The study may also test different schedules.