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

Part of paid clinical trials in Duarte, California.

Sponsor
Pfizer
Study ID
NCT07318805
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PF-08032562 — DRUG
    Taken by mouth (PO)
  • Fulvestrant — DRUG
    Selective Estrogen Receptor Degrader (SERD)
  • Cetuximab — DRUG
    Monoclonal antibody (EGFR inhibitor)
  • Fluorouracil — DRUG
    Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
  • Oxaliplatin — DRUG
    Part of FOLFOX chemotherapy regimen platinum based compound (alkylating agent)
  • Leucovorin — DRUG
    Part of FOLFOX chemotherapy regimen (folic acid analog)
  • Bevacizumab — DRUG
    Monoclonal antibody (VEG-F inhibitor)

Study Details

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.

Key Dates

Start date
Dec 23, 2025
Status verified
May 2026
Primary completion
Apr 14, 2029
Completion
Apr 14, 2030

Study Design

Enrollment
260 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Part 1 (Dose Escalation): Number of participants with Dose-Limiting Toxicities (DLT) [ Time Frame: Baseline up to 28 days ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)DuarteCalifornia91010-
START Midwest, LLCGrand RapidsMichigan49546-
The University of Texas MD Anderson Cancer Center - ConroeConroeTexas77384-
The University of Texas - M.D. Anderson Cancer CenterHoustonTexas77030-
The University of Texas, MD Anderson Cancer Center - West HoustonHoustonTexas77079-
The University of Texas, MD Anderson Cancer Center - League CityLeague CityTexas77573-
START San AntonioSan AntonioTexas78229-
The University of Texas, MD Anderson Cancer Center - Sugar LandSugar LandTexas77478-
START Mountain RegionWest Valley CityUtah84119-

Find similar trials in Duarte, CA

By condition
Colorectal cancerBreast cancer
By specialty
OncologyGI oncologyBreast oncologyWomen's health
By research site
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)· Duarte, CASTART Midwest, LLC· Grand Rapids, MIThe University of Texas MD Anderson Cancer Center - Conroe· Conroe, TXThe University of Texas - M.D. Anderson Cancer Center· Houston, TXThe University of Texas, MD Anderson Cancer Center - West Houston· Houston, TXThe University of Texas, MD Anderson Cancer Center - League City· League City, TX

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