Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Faeth Therapeutics
Study ID
NCT07558733
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • HR+ HER2- Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Serabelisib — DRUG
    Serabelisib is a selective, small molecule inhibitor of PI3Kα.
  • Sapanisertib — DRUG
    Sapanisertib is a small molecule inhibitor of the mammalian mTOR serine/threonine kinase.
  • Fulvestrant — DRUG
    Fulvestrant is a first-in-class SERD.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
May 31, 2029
Completion
May 31, 2033

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A1 - Sapanisertib and serabelisib (PIKTOR) with fulvestrant
    Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) administered orally and fulvestrant administered intramuscularly.
  • Experimental: Cohort A2 - Sapanisertib and serabelisib (PIKTOR) with fulvestrant
    Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) at a higher dose than Cohort A1 administered orally and fulvestrant administered intramuscularly.

Primary Outcome Measure

Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs) [ Time Frame: 2 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
START Los AngelesLos AngelesCalifornia90025-
Oncology Associates of OregonSpringfieldOregon97477-
SCRI Oncology PartnersNashvilleTennessee37203-

Find similar trials in Los Angeles, CA

By research site
START Los Angeles· Los Angeles, CAOncology Associates of Oregon· Springfield, ORSCRI Oncology Partners· Nashville, TN

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