Hope, grounded
in evidence.

Cancer is not an abstract challenge to us — it is the reason we exist. If you or someone you care for is living with advanced cancer, this page is your guide to Faeth's active clinical trials and expanded access policy.

CLINICAL TRIALS

Active studiesopen to patients.

Both of our active trials are currently enrolling patients. Speak with your oncologist about whether you may be eligible, and click on a trial below to view full details including eligibility criteria, study sites, and contact information on ClinicalTrials.gov.

Phase 2Enrolling

PIK-201

Advanced or Recurrent Endometrial Cancer

NCT06463028

An open-label, single-arm Phase 2 study of PIKTOR (serabelisib + sapanisertib) in combination with paclitaxel in patients with advanced or recurrent endometrial cancer who carry a confirmed PI3K/AKT/mTOR pathway mutation and have received prior checkpoint inhibitor and platinum-based therapy.

Key eligibility

Confirmed PI3K/AKT/mTOR pathway mutation
Prior treatment with checkpoint inhibitor and carboplatin
Advanced or recurrent endometrial cancer

View on ClinicalTrials.gov

Phase 1b/2Enrolling

PIK-101

HR+/HER2– Advanced Breast Cancer

NCT07558733

A Phase 1b/2 trial of PIKTOR (serabelisib + sapanisertib) in combination with fulvestrant and/or other anticancer therapies in patients with hormone receptor-positive, HER2-negative advanced breast cancer. The trial targets patients where PI3K pathway activation is a key driver of resistance to prior CDK4/6 inhibitor and endocrine therapy.

Key eligibility

HR+/HER2– advanced breast cancer
Prior systemic therapy

View on ClinicalTrials.gov

Investigational drug products. Not approved by the FDA or any other regulatory authority.

Reach ourclinical team.

Have questions about our clinical trials or whether you or a patient may be eligible? Fill out the form and a member of our clinical team will be in touch.

Physicians seeking information about expanded access should include that in their message. We aim to respond within five business days.

EXPANDED ACCESS

ExpandedAccess.

Expanded access (also known as compassionate use) allows some patients who cannot enroll in a clinical trial to potentially access investigational products. Our full policy is provided below.

FAETH