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

Study Identifier:
C6321001
CT.gov Identifier:
NCT07318805
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruiting

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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Breast Cancers
  • Breast
  • Bowel (Colorectal)
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: Part 1 Dose Escalation Cohort 1A
    • Read More
  • Drug: 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: Drug: PF-08032562
  • Drug: Taken by mouth (PO)
  • Drug: EXPERIMENTAL: Part 1 Dose Escalation Cohort 1B
  • Drug: Combination (PF-08032562 + fulvestrant) dose escalation for participants with advanced or metastatic BC, at different doses and/or schedules of the study drug
  • Drug: Drug: Fulvestrant
  • Drug: Selective Estrogen Receptor Degrader (SERD)
  • Drug: Other Names: Faslodex
  • Drug: EXPERIMENTAL: Part 1 Dose Escalation Cohort 1C
  • Drug: Combination (PF-08032562 + cetuximab) dose escalation for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug
  • Drug: Drug: Cetuximab
  • Drug: Monoclonal antibody (EGFR inhibitor)
  • Drug: Other Names: Erbitux
  • Drug: EXPERIMENTAL: Part 1 Dose Escalation Cohort 1D
  • Drug: 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: Drug: Bevacizumab
  • Drug: Monoclonal antibody (VEG-F inhibitor)
  • Drug: Other Names: Zirabev, Avastin
  • Drug: Drug: Fluorouracil
  • Drug: Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
  • Drug: Other Names: 5-FU, 5-Fluorouracil
  • Drug: Drug: Leucovorin
  • Drug: Part of FOLFOX chemotherapy regimen (folic acid analog)
  • Drug: Other Names: Folinic Acid, Wellcovorin, Calcium Folinate
  • Drug: Drug: Oxaliplatin
  • Drug: Part of FOLFOX chemotherapy regimen platinum based compound (alkylating agent)
  • Drug: Other Names: Eloxatin
  • Drug: EXPERIMENTAL: Part 2 Dose Expansion Cohort 2A
  • Drug: Combination (PF-08032562 + fulvestrant) dose expansion for participants with advanced or metastatic BC, at different doses and/or schedules of the study drug
  • Drug: EXPERIMENTAL: Part 2 Dose Expansion Cohort 2B
  • Drug: 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: EXPERIMENTAL: Part 2 Dose Expansion Cohort 2C
  • Drug: Combination (PF-08032562 + \[FOLFOX + bevacizumab\]) dose expansion for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers
    Breast
    Bowel (Colorectal)
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers
    Breast
    Bowel (Colorectal)
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Breast Cancers
    Breast
    Bowel (Colorectal)