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NCT Number: NCT07318805

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

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.

Recruiting

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Key information

Conditions

Advanced Breast Cancer Breast Diseases Breast Neoplasms Colonic Diseases Colonic Neoplasms Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Metastatic Breast Cancer (HR+/ HER2-) Metastatic Colorectal Adenocarcinoma Neoplasms Neoplasms by Site Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Cancer Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

City of Hope (City of Hope National Medical Center, City of Hope Medical Center), Duarte, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-08032562

Drug

Taken by mouth (PO)

Fulvestrant

Drug

Selective Estrogen Receptor Degrader (SERD)

Other names: Faslodex

Cetuximab

Drug

Monoclonal antibody (EGFR inhibitor)

Other names: Erbitux, Enlituo

Fluorouracil

Drug

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

Other names: 5-FU, 5-Fluorouracil

Oxaliplatin

Drug

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

Other names: Eloxatin

Leucovorin

Drug

Part of FOLFOX chemotherapy regimen (folic acid analog)

Other names: Folinic Acid, Wellcovorin, Calcium Folinate

Bevacizumab

Drug

Monoclonal antibody (VEG-F inhibitor)

Other names: Zirabev, Avastin

Primary outcomes

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

    Time frame: Baseline up to 28 days

    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.

  2. 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

    Number of participants with laboratory test abnormalities.

  3. 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

    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.

  4. 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)

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

Secondary outcomes

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

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

    Evaluate the single and multiple dose PK of PF-08032562 as monotherapy, or in combination with other anti-tumor agents.

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

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

    Evaluate the single and multiple dose PK of PF-08032562 as monotherapy, or in combination with other anti-tumor agents.

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

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

    Evaluate the single and multiple dose PK of PF-08032562 as monotherapy, or in combination with other anti-tumor agents.

  4. Part 1: Effect of Food on Cmax

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

    Evaluate the effect of food on Cmax of PF-08032562 as monotherapy

  5. Part 1: Effect of Food on Tmax

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

    Evaluate the effect of food on Tmax of PF-08032562 as monotherapy

  6. Part 1: Effect of Food on AUClast

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

    Evaluate the effect of food on AUClast of PF-08032562 as monotherapy

  7. Part 1: Percent change of immune cells within tumors based on immunohistochemistry assessment

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

    Evaluate the single and multiple dose pharmacodynamics of PF-08032562 as monotherapy, or in combination with other anti-tumor agents. This measure will assess change in the concentration of immune cell-related cytokines and chemokines as potential pharmacodynamic effects of PF-08032562 using Immunohistochemistry (IHC) assays.

  8. Part 2 (Dose Expansion): 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

    Number of participants with laboratory test abnormalities.

  9. Part 2 (Dose Expansion): 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

    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.

  10. Part 1 & Part 2: Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    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)

    ORR is defined as the percentage of participants in the analysis population having a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1.

  11. Part 1 & Part 2: Disease Control Rate (DCR) as per RECIST v1.1

    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)

    DCR is defined as the proportion of participants with CR or PR with confirmation, or Stable Disease (SD) per RECIST version 1.1.

  12. Part 1 & Part 2: Clinical Benefit Rate (CBR) as per RECIST v1.1

    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)

    CBR is defined as the percentage of participants with a best overall response of CR or PR at any time before Progressive Disease (PD), or non-CR/non-PD or SD for at least 24 weeks from start date of treatment and prior to PD, relative to the appropriate analysis set.

  13. Part 1 & Part 2: Duration of Response (DOR) as per RECIST v1.1

    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)

    DOR is defined as the time from first documentation of CR or PR to date of first documentation of PD or death due to any cause.

  14. Part 1 & Part 2: Progression-Free Survival (PFS) as per RECIST v1.1

    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)

    PFS is defined as time from start date of treatment to the date of first documentation of PD or death due to any cause.

  15. Part 1 & Part 2: Time to Response (TTR) as per RECIST v1.1

    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)

    TTR is defined as the time from start date of treatment to first documentation of CR or PR.

  16. Part 2: Overall Survival (OS)

    Time frame: Up to approximately 2 years

    OS is defined as time from from start date of treatment to the date of death due to any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Jan 6, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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