Combining sapanisertib and serabelisib (PIKTOR) with hormonal therapy for HR+/HER2- advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1b/2, multi-center, open-label, dose-escalation trial that gives sapanisertib and serabelisib (PIKTOR) alone or together with fulvestrant and other anticancer therapies to participants with HR+/HER2- advanced or metastatic breast cancer. The Phase 1b portion determines safe dose levels and the Phase 2 portion gathers preliminary evidence of anti-tumor activity. Eligible participants must have measurable disease per RECIST v1.1, an ECOG performance status of 0–1, and prior systemic therapy for advanced disease, while uncontrolled CNS metastases and certain active malignancies are excluded.

Why it matters

Who can join: the full rules

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.

Where it's running

• START Los Angeles
  Los Angeles, California, United States Recruiting
• Rocky Mountain Cancer Centers
  Lone Tree, Colorado, United States Recruiting
• Oncology Associates of Oregon
  Springfield, Oregon, United States Recruiting
• SCRI Oncology Partners
  Nashville, Tennessee, United States Recruiting
• Texas Oncology - Central/South
  Austin, Texas, United States Recruiting
• START San Antonio
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Medical Monitor
• Email: clinicaltrials@faeththerapeutics.com
• Phone: (708) 406-9282

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.