NCT07318805

A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors

A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-08032562 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Breast Cancer
• Metastatic Breast Cancer (HR+/ HER2-)
• Colorectal Cancer
• Metastatic Colorectal Adenocarcinoma
• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	PF-08032562	Taken by mouth (PO)
DRUG	Fulvestrant	Selective Estrogen Receptor Degrader (SERD)
DRUG	Cetuximab	Monoclonal antibody (EGFR inhibitor)
DRUG	Fluorouracil	Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
DRUG	Oxaliplatin	Part of FOLFOX chemotherapy regimen platinum based compound (alkylating agent)
DRUG	Leucovorin	Part of FOLFOX chemotherapy regimen (folic acid analog)
DRUG	Bevacizumab	Monoclonal antibody (VEG-F inhibitor)

Timeline

• Start date: 2025-12-16
• Primary completion: 2029-04-14
• Completion: 2030-04-14
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study