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RecruitingInterventionalPhase 1

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

NCT ID: NCT07318805Sponsor: PfizerLast updated: 2026-05-08

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.

Arms & interventions

  • DrugPF-08032562

    Taken by mouth (PO)

  • DrugFulvestrant

    Selective Estrogen Receptor Degrader (SERD)

  • DrugCetuximab

    Monoclonal antibody (EGFR inhibitor)

  • DrugFluorouracil

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

  • DrugOxaliplatin

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

  • DrugLeucovorin

    Part of FOLFOX chemotherapy regimen (folic acid analog)

  • DrugBevacizumab

    Monoclonal antibody (VEG-F inhibitor)

Outcome measures

Primary

  • 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.

    Time frame: Baseline up to 28 days

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

    Number of participants with laboratory test 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)

    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.

    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)

    ORR defined 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)

Secondary

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

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

  • 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)

  • 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)

  • Part 1: Effect of Food on Cmax

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

  • Part 1: Effect of Food on Tmax

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

  • Part 1: Effect of Food on AUClast

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

  • 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)

  • 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

  • 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

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • Part 2: Overall Survival (OS)

    Time frame: Up to approximately 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (9)

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

Duarte, California, 91010

Recruiting

START Midwest, LLC

Grand Rapids, Michigan, 49546

Recruiting

The University of Texas MD Anderson Cancer Center - Conroe

Conroe, Texas, 77384

Recruiting

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

Houston, Texas, 77030

Recruiting

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

Houston, Texas, 77079

Recruiting

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

League City, Texas, 77573

Recruiting

START San Antonio

San Antonio, Texas, 78229

Recruiting

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

Sugar Land, Texas, 77478

Recruiting

START Mountain Region

West Valley City, Utah, 84119

Recruiting