Recruiting
Phase 1

PF-08032562

Sponsor:

Pfizer

Code:

NCT07318805

Conditions

Advanced Breast Cancer

Metastatic Breast Cancer (HR+/ HER2-)

Colorectal Cancer

Metastatic Colorectal Adenocarcinoma

Triple Negative Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PF-08032562

Fulvestrant

Cetuximab

Fluorouracil

Oxaliplatin

Study Details

Brief 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

Study ID

NCT07318805

Start date

Dec 23, 2025

Status verified date

Jul, 2026

Completion date

Apr 14, 2030

Anticipated

Primary completion date

Apr 14, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

260 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 Dose Escalation Cohort 1A

PF-08032562 monotherapy dose escalation for participants with advanced or metastatic BC or CRC, at different doses and/or schedules of the study drug

experimental: Part 1 Dose Escalation Cohort 1B

Combination (PF-08032562 + fulvestrant) dose escalation for participants with advanced or metastatic BC, at different doses and/or schedules of the study drug

experimental: Part 1 Dose Escalation Cohort 1C

Combination (PF-08032562 + cetuximab) dose escalation for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug

experimental: Part 1 Dose Escalation Cohort 1D

Combination (PF-08032562 + \[FOLFOX + bevacizumab\]) dose escalation for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug

experimental: Part 2 Dose Expansion Cohort 2A

Combination (PF-08032562 + fulvestrant) dose expansion for participants with advanced or metastatic BC, at different doses and/or schedules of the study drug

experimental: Part 2 Dose Expansion Cohort 2B

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

experimental: Part 2 Dose Expansion Cohort 2C

Combination (PF-08032562 + \[FOLFOX + bevacizumab\]) dose expansion for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug

Interventions

PF-08032562

Taken by mouth (PO)

Fulvestrant

Selective Estrogen Receptor Degrader (SERD)

Cetuximab

Monoclonal antibody (EGFR inhibitor)

Fluorouracil

Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)

Oxaliplatin

Part of FOLFOX chemotherapy regimen platinum based compound (alkylating agent)

Leucovorin

Part of FOLFOX chemotherapy regimen (folic acid analog)

Bevacizumab

Monoclonal antibody (VEG-F inhibitor)

Primary outcome measure

  • Part 1 (Dose Escalation): Number of participants with Dose-Limiting Toxicities (DLT) [ Time Frame: Baseline up to 28 days ]
  • Part 1 (Dose Escalation): Number of participants with laboratory abnormalities [ Time Frame: From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first ]
  • Part 1 (Dose Escalation): Incidence of Adverse Events (AEs) [ Time Frame: 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) [ Time Frame: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Recruiting

Duarte, California, United States, 91010

START Midwest, LLC

Recruiting

Grand Rapids, Michigan, United States, 49546

Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

Recruiting

Long Island City, New York, United States, 11101

Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

Recruiting

New York, New York, United States, 10021

Memorial Sloan Kettering Cancer Center 53rd street.

Recruiting

New York, New York, United States, 10022

Memorial Sloan Kettering Cancer Center - Main Campus

Recruiting

New York, New York, United States, 10065

The University of Texas MD Anderson Cancer Center - Conroe

Recruiting

Conroe, Texas, United States, 77384

The University of Texas - M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

The University of Texas, MD Anderson Cancer Center - West Houston

Recruiting

Houston, Texas, United States, 77079

The University of Texas, MD Anderson Cancer Center - League City

Recruiting

League City, Texas, United States, 77573

START San Antonio

Recruiting

San Antonio, Texas, United States, 78229

The University of Texas, MD Anderson Cancer Center - Sugar Land

Recruiting

Sugar Land, Texas, United States, 77478

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

More Information

Sponsor

Pfizer

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Carcinoma, Breast
  • Estrogen Receptor Positive Breast Cancer
  • HER2- Breast Cancer
  • Triple Negative Breast Cancer
  • Colon Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pfizer on 2026-07-22.