PF-08032562 for Breast and Colorectal Cancer

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: Steroids

Disqualifiers: Brain metastases, Hypertension, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28-day cycles

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic breast or colorectal cancer. Participants must have tried standard therapies without success, or in some cases, not received any prior chemotherapy for their advanced disease. They should be relatively active and able to care for themselves (ECOG status 0-1) and have measurable signs of cancer.

Inclusion Criteria

I am 18 years old or older.

My cancer is advanced or has spread from the breast or colon.

My cancer can be measured by tests or scans.

Exclusion Criteria

Other unacceptable abnormalities as defined by protocol

I have kidney problems.

I have not had any cancer in the last 3 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study medication PF-08032562 alone or in combination with other anti-cancer medications in 28-day cycles

28-day cycles

Visits as per cycle schedule

Dose Escalation

Participants undergo dose escalation to determine the maximum tolerated dose of PF-08032562

Varies per cohort

Dose Expansion

Participants receive the determined dose to further evaluate safety and efficacy

Approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PF-08032562

Trial Overview

The study tests PF-08032562 alone or with other anti-cancer drugs like Fluorouracil, Fulvestrant, Bevacizumab, Leucovorin, Oxaliplatin, Cetuximab. It's taken orally over 28-day cycles; other drugs are given by injection or IV at the clinic on varying schedules to find the best dose and combination.

How Is the Trial Designed?

Group I: Part 2 Dose Expansion Cohort 2C Experimental Treatment 5 Interventions

Combination (PF-08032562 + \[FOLFOX + bevacizumab\]) dose expansion for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug

Group II: Part 2 Dose Expansion Cohort 2B Experimental Treatment 2 Interventions

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

Group III: Part 2 Dose Expansion Cohort 2A Experimental Treatment 2 Interventions

Combination (PF-08032562 + fulvestrant) dose expansion for participants with advanced or metastatic BC, at different doses and/or schedules of the study drug

Group IV: Part 1 Dose Escalation Cohort 1D Experimental Treatment 5 Interventions

Combination (PF-08032562 + \[FOLFOX + bevacizumab\]) dose escalation for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug

Group V: Part 1 Dose Escalation Cohort 1C Experimental Treatment 2 Interventions

Combination (PF-08032562 + cetuximab) dose escalation for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug

Group VI: Part 1 Dose Escalation Cohort 1B Experimental Treatment 2 Interventions

Combination (PF-08032562 + fulvestrant) dose escalation for participants with advanced or metastatic BC, at different doses and/or schedules of the study drug

Group VII: Part 1 Dose Escalation Cohort 1A Experimental Treatment 1 Intervention

PF-08032562 monotherapy dose escalation for participants with advanced or metastatic BC or CRC, at different doses and/or schedules of the study drug

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University