Print

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy 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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Drug: PF-08032562
    Taken by mouth (PO)
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
  • Drug: PF-08032562
    Taken by mouth (PO)
  • Drug: Fulvestrant
    Selective Estrogen Receptor Degrader (SERD)
    Other names:
    • Faslodex
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
  • Drug: PF-08032562
    Taken by mouth (PO)
  • Drug: Cetuximab
    Monoclonal antibody (EGFR inhibitor)
    Other names:
    • Erbitux
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
  • Drug: PF-08032562
    Taken by mouth (PO)
  • Drug: Fluorouracil
    Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
    Other names:
    • 5-FU
    • 5-Fluorouracil
  • Drug: Oxaliplatin
    Part of FOLFOX chemotherapy regimen platinum based compound (alkylating agent)
    Other names:
    • Eloxatin
  • Drug: Leucovorin
    Part of FOLFOX chemotherapy regimen (folic acid analog)
    Other names:
    • Folinic Acid
    • Wellcovorin
    • Calcium Folinate
  • Drug: Bevacizumab
    Monoclonal antibody (VEG-F inhibitor)
    Other names:
    • Zirabev
    • Avastin
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
  • Drug: PF-08032562
    Taken by mouth (PO)
  • Drug: Fulvestrant
    Selective Estrogen Receptor Degrader (SERD)
    Other names:
    • Faslodex
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
  • Drug: PF-08032562
    Taken by mouth (PO)
  • Drug: Cetuximab
    Monoclonal antibody (EGFR inhibitor)
    Other names:
    • Erbitux
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
  • Drug: PF-08032562
    Taken by mouth (PO)
  • Drug: Fluorouracil
    Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
    Other names:
    • 5-FU
    • 5-Fluorouracil
  • Drug: Oxaliplatin
    Part of FOLFOX chemotherapy regimen platinum based compound (alkylating agent)
    Other names:
    • Eloxatin
  • Drug: Leucovorin
    Part of FOLFOX chemotherapy regimen (folic acid analog)
    Other names:
    • Folinic Acid
    • Wellcovorin
    • Calcium Folinate
  • Drug: Bevacizumab
    Monoclonal antibody (VEG-F inhibitor)
    Other names:
    • Zirabev
    • Avastin

Recruiting Locations

START Midwest, LLC
Grand Rapids, Michigan 49546

The University of Texas MD Anderson Cancer Center - Conroe
Conroe, Texas 77384

The University of Texas - M.D. Anderson Cancer Center
Houston, Texas 77030

The University of Texas, MD Anderson Cancer Center - West Houston
Houston, Texas 77079

The University of Texas, MD Anderson Cancer Center - League City
League City, Texas 77573

START San Antonio
San Antonio, Texas 78229

The University of Texas, MD Anderson Cancer Center - Sugar Land
Sugar Land, Texas 77478

START Mountain Region
West Valley City, Utah 84119

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.