This is a Phase 1, two-part, multicenter study to evaluate ELA026 in participants ≥18
years old with relapsed/refractory TCM following any line of prior therapy who are
eligible for investigational treatments.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07465835.
This is the first clinical study of ELA026 as a therapy for R/R TCMs. The study will
begin with an initial dose finding component (Part 1, Phase 1a), enrolling approximately
6 to 18 participants (up to maximum of 24 participants) to identify up to 2 dosing
regimens with an acceptable safety profile. Upon completion of Part 1, the study will
proceed to the cohort expansion phase (Part 2, Phase 1b) to further evaluate these
regimens.
Parts 1 and 2 will include the following study periods:
- Screening period: up to 28 days
- Treatment period: up to 6 cycles or 24 weeks (1 cycle = 28 days)
- Optional extension period: On a case-by-case basis, participants experiencing
ongoing clinical benefits may continue treatment beyond 6 cycles, up to an
additional 6 cycles, with approval by the Sponsor
- Safety follow-up: 28 days after the last dose of study treatment
- Survival follow-up: up to 2 years from the end of treatment
Lead OrganizationElectra Therapeutics
