NCT07558733 Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
| NCT ID | NCT07558733 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Faeth Therapeutics |
| Condition | HR+ HER2- Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-04 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2026-04 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07558733 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HR+ HER2- Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07558733 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07558733 currently recruiting?
Yes, NCT07558733 is actively recruiting participants. Contact the research team at clinicaltrials@faeththerapeutics.com for enrollment information.
Where is the NCT07558733 trial being conducted?
This trial is being conducted at Los Angeles, United States, Springfield, United States, Nashville, United States.
Who is sponsoring the NCT07558733 clinical trial?
NCT07558733 is sponsored by Faeth Therapeutics. The trial plans to enroll 32 participants.
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