PF-07260437 for Solid Tumors

(C4431001 Trial)

Recruiting at 17 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: Immunosuppressive therapy

Disqualifiers: Active malignancy, Symptomatic visceral spread, others

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

Compensation: Varies

Number of Visits: 5

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a special protein treatment to help the immune system target and destroy cancer cells in adults with advanced breast, ovarian, or endometrial cancer. The treatment works by connecting immune cells to cancer cells, making it easier for the immune system to attack the cancer.

Will I have to stop taking my current medications?

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

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Inclusion Criteria

Part 2B: In second line or more participants with histological or cytological diagnosis of locally advance or metastatic HR+ Her2- breast cancer or triple negative breast cancer (TNBC) with no biomarker pre-selection

Part 2A:In second line or more, participants with histological/cytological diagnosis of locally advanced or metastatic HR+ HER2- breast cancer showing high B7-H4 expression

Thyroid function within normal laboratory range; in participants with abnormal thyroid function if Free T4 is normal and participant is clinically euthyroid, participants is eligible

Exclusion Criteria

Participants with any active malignancy within 3 years prior to enrollment

Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including participants with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement).

History of Grade ≥3 immune mediated adverse events (including liver function tests that where considered drug related and cytokine release syndrome) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co stimulatory agents, etc.) and required immunosuppressive therapy within 1 year of treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive PF-07260437 to evaluate safety, tolerability, and pharmacokinetics

4-6 weeks

Weekly visits for dose escalation monitoring

Dose Expansion

Participants receive PF-07260437 in tumor-specific arms to further evaluate antitumor activity

Up to 35.1 weeks

Visits every 3 weeks for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• PF-07260437

Participant Groups

Group I: Monotherapy dose escalation (Part 1) Experimental Treatment 1 Intervention

Participants will receive PF-07260437

Group II: Dose Expansion (Part 2C) - Tumor specific Arm C Experimental Treatment 2 Interventions

Participants will receive PF07260437

Group III: Dose Expansion (Part 2B) - Tumor specific Arm B Experimental Treatment 2 Interventions

Participants will receive PF-07260437

Group IV: Dose Expansion (Part 2A) - Tumor specific Arm A Experimental Treatment 2 Interventions

Participants will receive PF-07260437

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