Open-Label Umbrella Study to Evaluate Safety and Efficacy of Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced or Metastatic Breast Cancer
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically confirmed diagnosis of HR+/HER2- breast cancer.
• Documented evidence of advanced or recurrent disease that is not amenable to surgery/radiation for curative intent.
• Participant has received at least one prior systemic therapy.
• At least 1 measurable or evaluable target lesion according to RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at Screening.
• Non-pregnant, non-lactating females who are postmenopausal, surgically sterile or who agree to use effective contraceptive methods.
Locations
United States
California
START Los Angeles
RECRUITING
Los Angeles
Colorado
Rocky Mountain Cancer Centers
RECRUITING
Lone Tree
Oregon
Oncology Associates of Oregon
RECRUITING
Springfield
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
Texas Oncology - Central/South
RECRUITING
Austin
START San Antonio
RECRUITING
San Antonio
Texas Oncology - San Aantonio
RECRUITING
San Antonio
Contact Information
Primary
Medical Monitor
clinicaltrials@faeththerapeutics.com
(708) 406-9282
Time Frame
Start Date:2026-04-22
Estimated Completion Date:2033-05
Participants
Target number of participants:32
Treatments
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.