Study of eFT226 for Advanced Solid Tumors
This study is testing a new investigational drug called eFT226, alone and in combination with other approved cancer therapies like sotorasib, fulvestrant, abemaciclib, and trastuzumab. Researchers want to understand how safe eFT226 is, how it moves through the body, and if it can help treat certain advanced solid tumors. The study has already completed its first part, which helped identify the best dose of eFT226. You might be able to join if you are an adult with advanced breast cancer that has not responded to standard treatments or if you cannot tolerate them. The study will look at side effects and how well the treatment works over about 12 months.
- Study design
- This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It is designed to test different doses and combinations of eFT226 in about 30 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure side effects and the best dose through study completion, which is approximately 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies
At a glance
Conditions
Where it's being run
14 sites across 8 statesStudy leadership
- Douglas Warner, MD · STUDY_DIRECTOR · EFFECTOR Therapeutics, Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Parts 1a and 1b: MTDThrough study completion, approximately 12 months
determined by occurrence of first cycle DLTs within a 3+3 or 3+3+3 clinical trial design
- Parts 1a and 1b; incidence of AEs, serious adverse events (SAEs), and DLTsThrough study completion, approximately 12 months
according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
- Parts 1a and 1b: RP2DThrough study completion, approximately 12 months
determined by Incidence and type of DLTs
- Parts 1a and 1b: RP2DThrough study completion, approximately 12 months
determine by Incidence, type, and severity of AEs and SAEs graded as per NCI CTCAE
- Part 2: Objective Response Rate- EfficacyThrough study completion, approximately 12 months
defined as confirmed Complete Response (CR) or Partial Response (PR)
- Part 2: (Combination Cohorts) Determine MTDThrough study completion, approximately 12 months
determined by occurrence of first cycle Dose Limiting Toxicities (DLTs) within the study design
- Part 2: (Combination Cohorts) Incidence, type, and severity of AEs and SAEsThrough study completion, approximately 12 months
via adverse event monitoring
- Part 2: (Combination Cohorts) Determine RP2DThrough study completion, approximately 12 months
determined by incidence and type of DLTs, and incidence, type, and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Part 2: Percent change in tumor dimensions of target lesions- EfficacyThrough study completion, approximately 12 months
calculated by the percentage change from baseline in the sum of the LD of target lesions
- Part 2: Time to Response (TTR)- EfficacyThrough study completion, approximately 12 months
defined as the interval from the start of study therapy to the first documentation of an objective response
- Part 2: Duration of Response (DOR)- EfficacyThrough study completion, approximately 12 months
defined as the interval from the first documentation of objective response to the earlier of the first documentation of disease progression or death from any cause