A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-08165784 MONOTHERAPY AND COMBINATIONS IN PARTICIPANTS WITH PIK3CA-MUTATED ADVANCED OR METASTATIC SOLID TUMORS

Study Identifier:
C6631001
CT.gov Identifier:
NCT07897721
EudraCT Identifier:
202652717036
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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Study Summary

The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08165784) when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment given to stop the growth of cancer. This study also aims to find the best amount of study medication that can be given to patients.

This study is seeking participants with a specific type of breast cancer (BC) called hormone receptor-positive (HR+), HER2- negative (HER2-) breast cancer, or colorectal cancer (CRC) (cancer of the colon or rectum), that has a change (mutation) in a gene called PIK3CA. The cancer must be advanced or metastatic, meaning it has spread to other parts of the body or cannot be completely removed with surgery.

All participants in this study will take the study medication (PF-08165784) as a tablet by mouth. The participant may take the medicine at the study clinic during study visits or at home. Treatment will be given in 28-day cycles and will continue for as long as the participant remains in the study. Depending on which part of the study participants are enrolled into, they will receive the study medication (PF-08165784) alone or in combination with other anti-cancer medications.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
N/A
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Part 1 Dose Escalation Cohort 1A
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Drug: PF-08165784 monotherapy dose escalation for participants with advanced or metastatic BC at different doses of the study drug
Drug: Drug: PF-08165784
Drug: Taken by mouth (PO)
Drug: EXPERIMENTAL: Part 1 Dose Escalation Cohort 1B
Drug: Combination (PF-08165784 + fulvestrant) dose escalation for participants with advanced or metastatic BC, at different doses of the study drug
Drug: Drug: Fulvestrant
Drug: Selective Estrogen Receptor Degrader (SERD)
Drug: Other Names: Faslodex
Drug: EXPERIMENTAL: Part 1 Dose Escalation Cohort 1C
Drug: Combination (PF-08165784 + fulvestrant + atirmociclib) dose escalation for participants with advanced or metastatic BC, at different doses of the study drug
Drug: Drug: Atirmociclib
Drug: Selective cyclin-dependent kinase 4 (CDK4) inhibitor
Drug: Other Names: PF-07220060
Drug: EXPERIMENTAL: Part 1 Dose Escalation Cohort 1D
Drug: Combination (PF-08165784 + cetuximab) dose escalation for participants with advanced or metastatic CRC at different doses of the study drug
Drug: Drug: Cetuximab
Drug: Monoclonal antibody (EGFR inhibitor)
Drug: Other Names: Erbitux
Drug: EXPERIMENTAL: Part 2 Dose Optimization/Expansion Cohort 2A
Drug: Combination (PF-08165784 + letrozole + atirmociclib) dose optimization/expansion for participants with advanced or metastatic BC, at different doses of the study drug
Drug: Drug: Letrozole
Drug: Nonsteroidal aromatase inhibitor
Drug: Other Names: Femara
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
Inclusion criteria
  • * 18 years of age or older
  • * Advanced or metastatic cancer of the breast or colon Part 1A, 1B, and 1C: HR+/HER2- advanced or metastatic breast cancer with disease progression after at least 1 line of treatment with an endocrine therapy and cyclin-dependent kinase (CDK)4/6 inhibitor in the advanced or metastatic setting and received no more than 1 line of prior cytotoxic and/or 1 line of prior antibody-drug conjugate (ADC) therapy in the metastatic setting Part 1D: Metastatic or advanced colorectal cancer with at least having received chemotherapy and/or targeted therapy if appropriate Part 2A: HR+/HER2- advanced or metastatic breast cancer with no prior systemic therapy or chemotherapy for advanced or metastatic disease
  • * Phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) mutation
  • * Archived tumor specimen or fresh tumor biopsy
  • * Measurable disease
  • * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion criteria
  • Active or clinically significant dermatologic conditions
  • * Active malignancy within 3 years prior to enrollment
  • * Advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term
  • * Major surgery or radiation therapy within 3 weeks prior to study entry
  • * Prior irradiation to >25% of the bone marrow
  • * Active or history of pneumonitis/interstitial lung disease requiring corticosteroids
  • * Unmanageable ascites
  • * Prior treatment with phosphatidylinositol 3-kinase (PI3K)/protein kinase B (AKT)/mechanistic target of rapamycin (mTOR) pathway inhibitors may be permitted in certain study cohorts and excluded in others, as specified by the study protocol.
  • * Renal impairment
  • * Hepatic dysfunction
  • * Hematologic abnormalities
  • * Uncontrolled diabetes
  • * Cardiac abnormalities
  • * Active or history of clinically significant gastrointestinal (GI) or inflammatory GI disease
  • * Other unacceptable abnormalities or prohibited therapies as defined by protocol

Clinical Study Information for Healthcare Providers

By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START New York (Long Island)
Lake Success, NY, United States, 11042
Investigator
Geraldine O'Sullivan Coyne
Status
Will Be Recruiting
Condition(s) Treated at Site
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
Status
Will Be Recruiting
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Manish Sharma
Status
Will Be Recruiting
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Status
Will Be Recruiting
Condition(s) Treated at Site