A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors

NCT07318805 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: C63210012025-524387-38-00
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 9

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-); Metastatic Colorectal Adenocarcinoma; Triple Negative Breast Cancer; Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Part 1 (Dose Escalation): Number of participants with Dose-Limiting Toxicities (DLT)

  Any adverse events that are attributable to one, the other, or both study treatments, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes.

  Baseline up to 28 days

• Part 1 (Dose Escalation): Number of participants with laboratory abnormalities

  Number of participants with laboratory test abnormalities.

  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)

  An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.

  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)

  ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

  Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)

Secondary Outcomes (16)

• Part 1 & Part 2: Maximum Observed Serum Concentration (Cmax)

  Baseline through end of Cycle 1 (each cycle is 28 days)

• Part 1 & Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax)

  Baseline through end of Cycle 1 (each cycle is 28 days)

• Part 1: Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast)

  Baseline through end of Cycle 1 (each cycle is 28 days)

• Part 1: Effect of Food on Cmax

  Baseline through end of Cycle 1 (each cycle is 28 days)

• Part 1: Effect of Food on Tmax

  Baseline through end of Cycle 1 (each cycle is 28 days)

Study Arms (7)

Part 1 Dose Escalation Cohort 1A

EXPERIMENTAL

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

Drug: PF-08032562

Part 1 Dose Escalation Cohort 1B

EXPERIMENTAL

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

Drug: PF-08032562; Drug: Fulvestrant

Part 1 Dose Escalation Cohort 1C

EXPERIMENTAL

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

Drug: PF-08032562; Drug: Cetuximab

Part 1 Dose Escalation Cohort 1D

EXPERIMENTAL

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

Drug: PF-08032562; Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Bevacizumab

Part 2 Dose Expansion Cohort 2A

EXPERIMENTAL

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

Drug: PF-08032562; Drug: Fulvestrant

Part 2 Dose Expansion Cohort 2B

EXPERIMENTAL

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

Drug: PF-08032562; Drug: Cetuximab

Part 2 Dose Expansion Cohort 2C

EXPERIMENTAL

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

Drug: PF-08032562; Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Bevacizumab

Interventions

PF-08032562 DRUG

Taken by mouth (PO)

Part 1 Dose Escalation Cohort 1A; Part 1 Dose Escalation Cohort 1B; Part 1 Dose Escalation Cohort 1C; Part 1 Dose Escalation Cohort 1D; Part 2 Dose Expansion Cohort 2A; Part 2 Dose Expansion Cohort 2B; Part 2 Dose Expansion Cohort 2C

Fulvestrant DRUG

Selective Estrogen Receptor Degrader (SERD)

Also known as: Faslodex

Part 1 Dose Escalation Cohort 1B; Part 2 Dose Expansion Cohort 2A

Cetuximab DRUG

Monoclonal antibody (EGFR inhibitor)

Also known as: Erbitux, Enlituo

Part 1 Dose Escalation Cohort 1C; Part 2 Dose Expansion Cohort 2B

Fluorouracil DRUG

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

Also known as: 5-FU, 5-Fluorouracil

Part 1 Dose Escalation Cohort 1D; Part 2 Dose Expansion Cohort 2C

Oxaliplatin DRUG

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

Also known as: Eloxatin

Part 1 Dose Escalation Cohort 1D; Part 2 Dose Expansion Cohort 2C

Leucovorin DRUG

Part of FOLFOX chemotherapy regimen (folic acid analog)

Also known as: Folinic Acid, Wellcovorin, Calcium Folinate

Part 1 Dose Escalation Cohort 1D; Part 2 Dose Expansion Cohort 2C

Bevacizumab DRUG

Monoclonal antibody (VEG-F inhibitor)

Also known as: Zirabev, Avastin

Part 1 Dose Escalation Cohort 1D; Part 2 Dose Expansion Cohort 2C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

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

Duarte, California, 91010, United States

RECRUITING

START Midwest, LLC

Grand Rapids, Michigan, 49546, United States

RECRUITING

The University of Texas MD Anderson Cancer Center - Conroe

Conroe, Texas, 77384, United States

RECRUITING

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

Houston, Texas, 77030, United States

RECRUITING

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

Houston, Texas, 77079, United States

RECRUITING

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

League City, Texas, 77573, United States

RECRUITING

START San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

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

Sugar Land, Texas, 77478, United States

RECRUITING

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Triple Negative Breast Neoplasms; Colonic Neoplasms

Interventions

Fulvestrant; Cetuximab; Fluorouracil; Oxaliplatin; Leucovorin; Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 6, 2026
• Study Start: December 23, 2025
• Primary Completion (Estimated): April 14, 2029
• Study Completion (Estimated): April 14, 2030
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)