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.
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
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.
Parallel
Serabelisib
DrugSerabelisib is a selective, small molecule inhibitor of PI3Kα.
Sapanisertib
DrugSapanisertib is a small molecule inhibitor of the mammalian mTOR serine/threonine kinase.
Fulvestrant
DrugFulvestrant is a first-in-class SERD.
Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs)
Graded according to the National Cancer Institute (NCI CTCAE v5.0).
Objective Response Rate (ORR)
Defined as the proportion of participants from the Response-Evaluable population who have confirmed best overall response of either CR or PR according to RECIST v1.1 as confirmed by the Investigator.
Progression Free Survival (PFS)
Defined as the time from first dose to the date of the first evidence of disease progression or death.
Progression Free Survival (PFS) at 6 months
Defined as the progression free survival (PFS) rate at 6 months.
Overall Survival (OS)
Defined as the time from first dose to the date of death due to any cause.
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