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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT07558733Sponsor: Faeth TherapeuticsLast updated: 2026-04-30

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.

Detailed description

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.

Arms & interventions

  • DrugSerabelisib

    Serabelisib is a selective, small molecule inhibitor of PI3Kα.

  • DrugSapanisertib

    Sapanisertib is a small molecule inhibitor of the mammalian mTOR serine/threonine kinase.

  • DrugFulvestrant

    Fulvestrant is a first-in-class SERD.

Outcome measures

Primary

  • 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).

    Time frame: 2 years

Secondary

  • Objective Response Rate (ORR)

    Time frame: Up to 2 years.

  • Progression Free Survival (PFS)

    Time frame: Up to 5 years.

  • Progression Free Survival (PFS) at 6 months

    Time frame: 6 months

  • Overall Survival (OS)

    Time frame: Up to 5 years.

  • Clinical Benefit Rate (CBR)

    Time frame: Up to 5 years.

  • Duration of Response (DoR)

    Time frame: Up to 5 years.

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (3)

START Los Angeles

Los Angeles, California, 90025

Recruiting

Oncology Associates of Oregon

Springfield, Oregon, 97477

Recruiting

SCRI Oncology Partners

Nashville, Tennessee, 37203

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