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?

This trial tests a new medication, PF-08032562, to evaluate its safety and effectiveness for individuals with advanced or metastatic breast or colorectal cancer. Participants will take this medication in pill form, and some will also receive additional cancer treatments through injections or infusions. The trial aims to determine the optimal dose and treatment schedule. Individuals with advanced breast or colorectal cancer who have not responded to other treatments might be suitable candidates for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is investigating the safety of PF-08032562, both alone and in combination with other cancer treatments. These studies are in the early stages and primarily focus on the drug's safety. Clear information on side effects when PF-08032562 is used alone is not yet available.

When combined with other drugs, the following is known: Fulvestrant, when used with other medications, is usually well-tolerated. Common side effects might include tiredness and nausea, but serious reactions are rare.

Cetuximab is another drug tested with PF-08032562. It is already approved for some uses, and its side effects can include skin issues and low magnesium levels. It is considered safe when used properly.

The combination of FOLFOX (a type of chemotherapy) and bevacizumab is effective but can increase side effects like high blood pressure and bleeding risk. Careful monitoring can manage these side effects.

Overall, the safety of PF-08032562, especially in combination with these treatments, is still under study. Participants will be closely monitored to manage any possible side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-08032562 because it introduces a novel approach to treating advanced or metastatic breast and colorectal cancers. Unlike conventional treatments such as chemotherapy or targeted therapies, PF-08032562 is being explored both as a monotherapy and in combination with other drugs like fulvestrant, cetuximab, FOLFOX, and bevacizumab. This combination strategy aims to enhance effectiveness by targeting multiple pathways involved in cancer progression. Additionally, the dose escalation and expansion trials allow researchers to fine-tune the optimal dosage and schedule, potentially leading to improved outcomes for patients.

What evidence suggests that this trial's treatments could be effective for advanced or metastatic breast and colorectal cancer?

Research shows that PF-08032562 is being explored as a new treatment for advanced breast and colorectal cancers. In this trial, participants may receive PF-08032562 in different combinations. For breast cancer, one arm combines PF-08032562 with fulvestrant, a drug proven effective for breast cancer, potentially increasing positive outcomes. For colorectal cancer, other arms combine PF-08032562 with cetuximab or the FOLFOX-bevacizumab treatment plan, which past studies have found promising. These combinations have been associated with longer survival in previous research. However, PF-08032562 remains under investigation, and its exact effectiveness is not yet fully known. The trial aims to find the best dose and combination to effectively fight these cancers. ^{2 3 4 6 7}

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

Citations

1.

pfizerclinicaltrials.com

pfizerclinicaltrials.com/find-a-trial/nct07318805-advanced-breast-cancer-trial

Clinical Trial for Advanced Breast Cancer, Metastatic ...

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- ...

2.

withpower.com

withpower.com/trial/phase-1-breast-neoplasms-11-2025-ab1b2

PF-08032562 for Breast and Colorectal Cancer

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.

3.

ctv.veeva.com

ctv.veeva.com/study/a-study-to-learn-about-the-study-medicine-called-pf-08032562-in-people-with-advanced-or-metastatic-s

A Study to Learn About the Study Medicine Called PF ...

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 ...

4.

htsyndication.com

htsyndication.com/health-daily-digest/article/clinical-trial%3A-a-study-to-learn-about-the-study-medicine-called-pf-08032562-in-people-with-advanced-or-metastatic-solid-tumors/96408891

Clinical Trial: A Study to Learn About the Study Medicine ...

This study is seeking participants that have advanced or metastatic breast cancer (BC), or advanced or metastatic colorectal cancer (CRC). All ...

5.

facingourrisk.org

facingourrisk.org/research-clinical-trials/results/printable?amp%3Bstage=stage%204&amp%3Bstudy_type=treatment&cancer_type=breast&page=2

Force Research Search Results | Printable

This study is for people with advanced or metastatic breast cancer, have a BRCA1 or BRCA2 genetic mutation and were previously treated with a PARP inhibitor.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07318805

A Study to Learn About the Study Medicine Called PF ...

The study medication (PF-08032562) will be taken by mouth (PO) in combination with other anti-cancer medications given in the study clinic by ...

7.

smartpatients.com

smartpatients.com/trials/NCT07318805

A Study to Learn About the Study Medicine Called PF ...

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 ...