NCT07897721Not yet recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors
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
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 268 (estimated)
- First submitted
- 20 Oct 2026
- Start date
- 9 Nov 2026
- Primary completion date
- 22 Mar 2030
- Lead sponsor
- Pfizer
- NCT number
- NCT07897721
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 268
- From 9 Nov 2026 to the primary completion date, 22 Mar 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active malignancy within 3 years prior to enrollment
- Major surgery or radiation therapy within 3 weeks prior to study entry
- Prior irradiation to \>25% of the bone marrow
- 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.
- Other unacceptable abnormalities or prohibited therapies as defined by protocol
Other illness
- Active or clinically significant dermatologic conditions
- Active or history of pneumonitis/interstitial lung disease requiring corticosteroids
- Renal impairment
- Uncontrolled diabetes
- Cardiac abnormalities
- Active or history of clinically significant gastrointestinal (GI) or inflammatory GI disease
Other
- Advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term
- Unmanageable ascites
- Hepatic dysfunction
- Hematologic abnormalities
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.