PF-08032562 for advanced breast cancer and colorectal cancer
Tests PF-08032562 alone or with other treatments in adults with advanced breast or colorectal cancer.
Key facts
- Who runs it
- Pfizer
- Where
- Poitiers and Villejuif Cedex, FranceSee the 2 sitesAlso in 2 other countries, 17 sites
- Trial code
- Registry title
- A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 260 people, planned
- Started
- 23 Dec 2025
- Expected to end
- 14 Apr 2030
- Type of study
- Interventional, 7 groups
- Treatments tested
- PF-08032562
- Fulvestrant
- Cetuximab
- Fluorouracil
- Oxaliplatin
- Leucovorin
- Bevacizumab
- Record updated
- 5 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic breast cancer or colorectal cancer. It tests the study medicine PF-08032562 alone or with other cancer medicines.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Advanced or metastatic breast cancer or colorectal cancer, with measurable disease. Some study parts need breast cancer that got worse after earlier treatment. Others need colorectal cancer, with or without earlier chemotherapy.
- Earlier treatment
- Depends on the study part. Breast cancer: at least 1 line of endocrine therapy and a CDK4/6 inhibitor. Colorectal cancer: chemotherapy and/or targeted therapy if appropriate, or none for advanced disease. Part 1A: no standard therapy available.
Main reasons for not taking part
- Another active cancer within 3 years before joining
- Known brain metastases with symptoms that need steroids
- Prior radiation to more than 25% of the bone marrow
- High blood pressure that medicine cannot control
- Kidney, liver or heart problems, active bleeding disorder, or significant gut disease
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Active malignancy within 3 years prior to enrollment
- Known symptomatic brain metastases requiring steroids
- Prior irradiation to >25% of the bone marrow
- Hypertension that cannot be controlled by optimal medical therapy
- Renal impairment
- Cardiac abnormalities
- Active bleeding disorder
- Active or history of clinically significant GI disease
- Advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term
- Hepatic dysfunction
- Other unacceptable abnormalities as defined by protocol
Where in France
Also in 2 other countries, 17 sites
- Centre Hospitalier Universitaire de PoitiersPoitiers, FranceNot yet recruiting
- Institut Gustave RoussyVillejuif Cedex, FranceNot yet recruiting
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 7 groups in the trial
- Part 1 Dose Escalation Cohort 1ATreatment being tested
PF-08032562 monotherapy dose escalation for participants with advanced or metastatic BC or CRC, at different doses and/or schedules of the study drug
Treatment: PF-08032562
- Part 1 Dose Escalation Cohort 1BTreatment being tested
Combination (PF-08032562 + fulvestrant) dose escalation for participants with advanced or metastatic BC, at different doses and/or schedules of the study drug
Treatment: PF-08032562 and Fulvestrant
- Part 1 Dose Escalation Cohort 1CTreatment being tested
Combination (PF-08032562 + cetuximab) dose escalation for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug
Treatment: PF-08032562 and Cetuximab
- Part 1 Dose Escalation Cohort 1DTreatment being tested
Combination (PF-08032562 + \[FOLFOX + bevacizumab\]) dose escalation for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug
Treatment: PF-08032562, Fluorouracil, Oxaliplatin, Leucovorin, and Bevacizumab
- Part 2 Dose Expansion Cohort 2ATreatment being tested
Combination (PF-08032562 + fulvestrant) dose expansion for participants with advanced or metastatic BC, at different doses and/or schedules of the study drug
Treatment: PF-08032562 and Fulvestrant
- Part 2 Dose Expansion Cohort 2BTreatment being tested
PF-08032562 monotherapy or combination (PF-08032562 + cetuximab) dose expansion for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug
Treatment: PF-08032562 and Cetuximab
- Part 2 Dose Expansion Cohort 2CTreatment being tested
Combination (PF-08032562 + \[FOLFOX + bevacizumab\]) dose expansion for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug
Treatment: PF-08032562, Fluorouracil, Oxaliplatin, Leucovorin, and Bevacizumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- PF-08032562 for advanced breast cancer and colorectal cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 November 2026