Actively Recruiting
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
Led by Pfizer · Updated on 2026-05-08
260
Participants Needed
9
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of a study medicine called PF-08032562 in people with advanced or metastatic breast cancer or colorectal cancer. This study aims to determine the best dose of this medication, which is given alone or together with other anti-cancer therapies. The study is a Phase 1 trial focused on dose escalation and expansion to assess safety, tolerability, and anti-tumor activity. Participants will take PF-08032562 as a pill by mouth in 28-day cycles. Depending on the study group, participants may receive PF-08032562 alone or combined with other anti-cancer drugs such as fulvestrant, cetuximab, or a chemotherapy regimen called FOLFOX with bevacizumab. These additional medications are given by injection into the muscle or vein at various times during each cycle. Different doses and schedules of PF-08032562 will be tested in separate parts of the study. During the study, researchers will monitor participants for side effects and measure tumor response through regular assessments every 8 to 12 weeks for up to about two years. Blood tests will be done to study the drug's levels and effects on immune cells. Safety will be closely followed from treatment start until 30 days after the last dose or new therapy. The trial involves multiple phases including dose escalation and dose expansion cohorts, with ongoing evaluation of treatment effects and tolerability.
CONDITIONS
Brief Title
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Advanced or metastatic breast or colorectal cancer as defined by study parts
- Measurable disease
- ECOG performance status of 0 or 1
- Specific prior treatments depending on the study part, including previous endocrine therapy, CDK4/6 inhibitors, chemotherapy, or targeted therapy as applicable
You will not qualify if you...
- Active malignancy within 3 years prior to enrollment
- Known symptomatic brain metastases requiring steroid treatment
- Advanced or metastatic symptomatic visceral spread at risk of life-threatening complications
- Prior radiation to more than 25% of bone marrow
- Uncontrolled hypertension
- Renal impairment
- Liver dysfunction
- Cardiac abnormalities
- Active bleeding disorders
- Active or history of significant gastrointestinal disease
- Other unacceptable abnormalities as defined by the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression, unacceptable toxicity, or discontinuation
Participants receive PF-08032562 alone or in combination with other cancer therapies. Treatment is given in repeated 28-day cycles at different doses and schedules depending on the study part and cohort.
Visits every 8 to 12 weeks for assessments, with additional treatment visits as per dosing schedule
Duration - Up to approximately 2 years
Participants are monitored for safety and long-term outcomes after the end of treatment, including survival and disease progression assessments.
Assessments approximately every 8 to 12 weeks through study completion
Trial Site Locations
Total: 9 locations
1
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States, 91010
Actively Recruiting
2
START Midwest, LLC
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
The University of Texas MD Anderson Cancer Center - Conroe
Conroe, Texas, United States, 77384
Actively Recruiting
4
The University of Texas - M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
The University of Texas, MD Anderson Cancer Center - West Houston
Houston, Texas, United States, 77079
Actively Recruiting
6
The University of Texas, MD Anderson Cancer Center - League City
League City, Texas, United States, 77573
Actively Recruiting
7
START San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
8
The University of Texas, MD Anderson Cancer Center - Sugar Land
Sugar Land, Texas, United States, 77478
Actively Recruiting
9
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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