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Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 27, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07897721). This is a study registration, not published results. Lead sponsor: Pfizer. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 268 participants (ESTIMATED). Conditions: Advanced Breast Cancer, Advanced or Metastatic Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Metastatic Colorectal Adenocarcinoma. Interventions: DRUG: PF-08165784; DRUG: Fulvestrant; DRUG: Atirmociclib; DRUG: Cetuximab; DRUG: Letrozole. Primary outcome measures: Part 1 (Dose Escalation): Number of participants with Dose-Limiting Toxicities (DLT) , Baseline up to 28 days; 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 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 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 (called PF-08165784) when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment given to stop the growth of cancer. This study also aims to find the best amount of study medication that can be given to patients. This study is seeking participants with a specific type of breast cancer (BC) called hormone receptor-positive (HR+), HER2- negative (HER2-) breast cancer, or colorectal cancer (CRC) (cancer of the colon or rectum), that has a change (mutation) in a gene called PIK3CA. The cancer must be advanced or metastatic, meaning it has spread to other parts of the body or cannot be completely removed with surgery. All participants in this study will take the study medication (PF-08165784) as a tablet by mouth. The participant may take the medicine at the study clinic during study visits or at home. Treatment will be given in 28-day cycles and will continue for as long as the participant remains in the study. Depending on which part of the study participants are enrolled into, they will receive the study medication (PF-08165784) alone or in combination with other anti-cancer medications.