Actively Recruiting
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
Led by Faeth Therapeutics · Updated on 2026-04-30
32
Participants Needed
3
Research Sites
369 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.
CONDITIONS
Official Title
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of HR+/HER2- breast cancer.
- Documented advanced or recurrent disease not suitable for curative surgery or radiation.
- Received at least one prior systemic therapy.
- At least one measurable or evaluable target lesion per RECIST v1.1.
- ECOG performance status of 0 or 1 at screening.
- Female participants must be non-pregnant, non-lactating, postmenopausal, surgically sterile, or agree to use effective contraception.
You will not qualify if you...
- Diagnosis of triple-negative breast cancer.
- Presence of central nervous system metastases unless local therapy completed and corticosteroids stopped at least 4 weeks before treatment.
- Active malignancy (other than breast cancer or certain treated carcinomas) within 24 months before treatment.
- Conditions affecting absorption of study treatment such as gastric feeding tube or bowel obstruction.
- Significant cardiovascular impairment.
- Active, uncontrolled infection.
- Concurrent participation in another therapeutic clinical trial.
- Radiation therapy within 21 days before study treatment starts.
- Prior treatment with PI3K, AKT, mTORC1/2, or dual PI3K/mTOR inhibitors.
- Use of strong CYP3A4 or CYP1A2 inhibitors or inducers within 7 days before first dose or need for these during study.
- QTc interval prolongation over 480 ms.
- Type 1 or Type 2 diabetes mellitus treated with insulin.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
START Los Angeles
Los Angeles, California, United States, 90025
Actively Recruiting
2
Oncology Associates of Oregon
Springfield, Oregon, United States, 97477
Actively Recruiting
3
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
M
Medical Monitor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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