RecruitingRecruiting
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
NCT07558733 · Faeth Therapeutics
In plain English
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Official title
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
About this study
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 criteria
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.
Study design
Enrollment target: 32 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04-22
Estimated completion: 2033-05
Last updated: 2026-07-02
Interventions
Drug: SerabelisibDrug: SapanisertibDrug: Fulvestrant
Primary outcomes
- • Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs) (2 years)
Sponsor
Faeth Therapeutics · industry
Contacts & investigators
ContactMedical Monitor · contact · clinicaltrials@faeththerapeutics.com · (708) 406-9282
All locations (7)
START Los AngelesRecruiting
Los Angeles, California, United States
Rocky Mountain Cancer CentersRecruiting
Lone Tree, Colorado, United States
Oncology Associates of OregonRecruiting
Springfield, Oregon, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Texas Oncology - Central/SouthRecruiting
Austin, Texas, United States
START San AntonioRecruiting
San Antonio, Texas, United States
Texas Oncology - San AantonioRecruiting
San Antonio, Texas, United States