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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Weekly maintenance dosing via subcutaneous injection
Yale New Haven Hospital
New Haven, Connecticut, United States
RECRUITINGEmory University Hospital
Atlanta, Georgia, United States
RECRUITINGSTART, Midwest
Grand Rapids, Michigan, United States
DLTs and treatment emergent adverse events (TEAEs), including serious adverse advents (SAEs)
Incidence of DLTs and treatment emergent adverse events (TEAEs), including serious adverse advents (SAEs)
Time frame: DLTs from baseline to DLT window (35 days) and SAEs from baseline through end of safety follow up (approximately 28 weeks for those participants not continuing to optional extension phase)
Objective response rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants who achieve a documented complete response (CR) or partial response (PR)
Time frame: To be assessed at 8 weeks, 16 weeks and 24 weeks after enrollment
Duration of response (DOR)
Duration of response (DOR) defined as the time from the first documentation of CR or PR to the first documentation of disease progression or death due to any cause on study, whichever occurs first
Time frame: Up to two years
Disease control rate (DCR)
Disease control rate (DCR) defined as the proportion of participants with CR, PR, or stable disease (SD)
Time frame: Up to two years
Clinical Trials Electra Clinical Trials Information
CONTACT
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Memorial Sloan Kettering
New York, New York, United States
RECRUITINGUniversity Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITINGMD Anderson
Houston, Texas, United States
RECRUITING