New oral medicine PF-08032562 for advanced or metastatic breast and colorectal cancer
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
This trial will try an oral medicine called PF-08032562, given alone or with other cancer drugs, in adults with advanced or metastatic breast or colorectal cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 9 sites (Duarte, California and 8 other locations) |
| Trial ID | NCT07318805 on ClinicalTrials.gov |
What this trial studies
This Phase 1, open-label trial gives PF-08032562 by mouth in 28-day cycles to adults with advanced or metastatic breast or colorectal cancers. Participants are enrolled into different parts to receive PF-08032562 alone or combined with approved anti-cancer drugs such as fulvestrant, cetuximab, fluorouracil, or oxaliplatin, with dosing schedules determined per cohort. The study's main goals are to define safety, side effects, and the best dose, with patients monitored regularly during treatment and for response using clinical and laboratory measures.
Who should consider this trial
Good fit: Adults with advanced or metastatic breast cancer (including HR+/HER2- and triple-negative subtypes) or advanced/metastatic colorectal cancer who meet the study part-specific prior treatment requirements and have no standard therapy options are potential candidates.
Not a fit: Patients with early-stage disease, those whose cancer is controlled by standard treatments, or those with medical conditions that make the study drugs unsafe are unlikely to benefit.
Why it matters
Potential benefit: If effective, PF-08032562 could provide a new oral treatment option that slows tumor growth or improves responses when added to existing therapies.
How similar studies have performed: Combination approaches using endocrine agents or EGFR-directed therapy with novel agents have shown activity in these cancers, but PF-08032562 itself is an early-stage, investigational drug with limited prior human data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older * Advanced or metastatic cancer of the breast or colon Part 1A: metastatic or advanced breast cancer or colorectal cancer for which no standard therapy is available Part 1B: metastatic or advanced breast cancer with disease progression after at least 1 line of treatment with an endocrine therapy and CDK4/6 inhibitor in the advanced or metastatic setting Part 1C: metastatic or advanced colorectal cancer with at least having received chemotherapy and/or targeted therapy if appropriate Part 1D: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease Part 2A: metastatic or advanced breast cancer with disease progression after at least 1 prior line of CDK4/6 inhibitor and at least 1 prior line of endocrine therapy Part 2B: metastatic or advanced colorectal cancer with at least having received chemotherapy and/or targeted therapy if appropriate Part 2C: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease * Measurable disease * ECOG performance status 0 or 1 Exclusion Criteria: * Active malignancy within 3 years prior to enrollment * Known symptomatic brain metastases requiring steroids * Advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term * Prior irradiation to \>25% of the bone marrow * Hypertension that cannot be controlled by optimal medical therapy * Renal impairment * Hepatic dysfunction * Cardiac abnormalities * Active bleeding disorder * Active or history of clinically significant GI disease * Other unacceptable abnormalities as defined by protocol
Where this trial is running
Duarte, California and 8 other locations
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California, United States (Recruiting)
- START Midwest, LLC — Grand Rapids, Michigan, United States (Recruiting)
- The University of Texas MD Anderson Cancer Center - Conroe — Conroe, Texas, United States (Recruiting)
- The University of Texas - M.D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- The University of Texas, MD Anderson Cancer Center - West Houston — Houston, Texas, United States (Recruiting)
- The University of Texas, MD Anderson Cancer Center - League City — League City, Texas, United States (Recruiting)
- START San Antonio — San Antonio, Texas, United States (Recruiting)
- The University of Texas, MD Anderson Cancer Center - Sugar Land — Sugar Land, Texas, United States (Recruiting)
- START Mountain Region — West Valley City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.