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

Study Identifier:
FTH-PIK-101
CT.gov Identifier:
NCT07558733
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study 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.

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.
Breast
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/II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Cohort A1 - Sapanisertib and serabelisib (PIKTOR) with fulvestrant
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Drug: Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) administered orally and fulvestrant administered intramuscularly.
Drug: Drug: Fulvestrant
Drug: Fulvestrant is a first-in-class SERD.
Drug: Drug: Sapanisertib
Drug: Sapanisertib is a small molecule inhibitor of the mammalian mTOR serine/threonine kinase.
Drug: Drug: Serabelisib
Drug: Serabelisib is a selective, small molecule inhibitor of PI3Kα.
Drug: EXPERIMENTAL: Cohort A2 - Sapanisertib and serabelisib (PIKTOR) with fulvestrant
Drug: Subjects will receive doses of sapanisertib and serabelisib (PIKTOR) at a higher dose than Cohort A1 administered orally and fulvestrant administered intramuscularly.
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • * 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.
Exclusion criteria
  • Participants with triple-negative breast cancer.
  • * Participants with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study.
  • * Active malignancy (except for breast cancer, definitively treated in-situ carcinomas [e.g., breast, cervix, bladder], or basal or squamous cell carcinoma of the skin) within the past 24 months prior to treatment. Fully resected localized malignancies are eligible.
  • * Gastric feeding tube (gastrostomy tube), gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment.
  • * Significant cardiovascular impairment.
  • * Active, uncontrolled infection.
  • * Concurrent participation in another therapeutic clinical trial.
  • * Prior radiation therapy within 21 days prior to start of study treatment.
  • * Participants who have received a prior PI3K, AKT, mTORC1/2, or dual PI3K/mTOR inhibitor.
  • * Strong CYP3A4 inhibitors, strong CYP1A2 inhibitors or CYP1A2 inducers, or clinically significant CYP3A4 inducers within 7 days before the first dose of study intervention, or participants who require treatment with strong CYP3A4 inhibitors or inducers during the study.
  • * Prolongation of QTc interval to >480 ms.
  • * Type 1 or Type 2 diabetes mellitus on insulin.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Los Angeles
Los Angeles, CA, United States, 90025
Investigator
Navid Hafez
Status
Recruiting
Condition(s) Treated at Site
Breast
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Amita Patnaik
Status
Recruiting
Condition(s) Treated at Site
Breast