New oral medicine PF-08032562 for advanced or metastatic breast and colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
  Long Island City, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
  New York, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center 53rd street.
  New York, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center - Main Campus
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.