PF-07104091 for Breast Cancer

Recruiting at 54 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Pfizer

Must not be taking: Steroids, Anticoagulants, CYP3A4/5 inhibitors

Disqualifiers: Brain metastases, Active infection, Heart disease, others

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

Compensation: Varies

Number of Visits: 1

154 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called PF-07104091 to see if it is safe and well-tolerated in adults with various advanced cancers. The goal is to find the highest dose that can be taken without severe side effects and determine the best dose for future studies.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for adults with certain advanced cancers: small cell lung cancer (SCLC), ovarian, or breast cancer. Participants must have a performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but can do light work. They should have received prior treatments specific to their cancer type and must not have any serious heart conditions, uncontrolled infections, recent major surgeries, other active malignancies within the last three years, or be pregnant.

Inclusion Criteria

My cancer is small cell lung cancer and has spread.

I have TNBC and received up to 2 chemotherapy treatments for advanced cancer.

My lung cancer has spread to other parts of my body.

Exclusion Criteria

I cannot take certain injections due to bleeding disorders or being on blood thinners.

A pregnancy test shows that you are pregnant at the time of screening.

Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive increasing doses of PF-07104091 to assess safety and determine the Maximum Tolerated Dose (MTD)

28 days

Day 1 and Day 15 of Cycle 1

Dose Expansion

Participants receive the Recommended Phase 2 Dose (RP2D) to further evaluate safety and antitumor activity

Approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 2 years

Treatment Details

Interventions

• PF-07104091

Trial Overview The trial tests different doses and combinations of PF-07104091 to find the safest and most effective dose for treating advanced cancers. It includes monotherapy (PF-07104091 alone) and combination therapies with drugs like fulvestrant and palbociclib. The goal is to determine the maximum tolerated dose (MTD) and/or recommend a Phase 2 dose (RP2D).

Participant Groups

Group I: PF-07104091 monotherapy dose expansion (ovarian) Experimental Treatment 1 Intervention

PF-07104091 monotherapy dose expansion (ovarian)

Group II: PF-07104091 monotherapy dose expansion (SCLC) Experimental Treatment 1 Intervention

PF-07104091 monotherapy dose expansion (SCLC)

Group III: PF-07104091 + palbociclib + letrozole Experimental Treatment 1 Intervention

CDK2 + palbociclib + letrozole

Group IV: PF-07104091 + palbociclib + fulvestrant Experimental Treatment 1 Intervention

CDK2 + palbociclib + fulvestrant

Group V: PF-07104091 + fulvestrant (post CDK4/6) dose expansion Experimental Treatment 1 Intervention

PF-07104091 + fulvestrant (post CDK4/6) dose expansion

Group VI: PF-07104091 + fulvestrant (post CDK 4/6) dose escalation Experimental Treatment 1 Intervention

CDK2+ fulvestrant (post CDK 4/6) dose escalation

Group VII: PF-07104091 Experimental Treatment 1 Intervention

CDK2 monotherapy dose escalation

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