A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignancies

Part of paid clinical trials in Miami Beach, Florida.

Sponsor
Curis, Inc.
Study ID
NCT07271667
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Emavusertib — DRUG
    Oral tablets
  • Zanubrutinib — DRUG
    Oral capsules

Study Details

The primary objective of the study for Cohort 1 and Cohort 2 is to assess the anticancer activity of emavusertib in combination with zanubrutinib in participants with CLL.

Key Dates

Start date
Apr 23, 2026
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
108 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Emavusertib and Zanubrutinib
    Participants in Cohort 1 include CLL participants who have been on zanubrutinib for at least 12 months and are currently in a partial response (PR) or partial response with lymphocytosis (PR-L) and measurable residual disease positive (MRD+). In Part A, participants will receive one of two doses of emavusertib twice daily (BID) and an approved dose of zanubrutinib per label. In Part B, additional participants will be enrolled in an expansion if pre-defined criteria for Part A are met. Participants will receive one of two doses of emavusertib BID and an approved dose of zanubrutinib per label.
  • Experimental: Cohort 2: Emavusertib and Zanubrutinib
    Participants in Cohort 2 include relapsed CLL participants who have directly progressed on zanubrutinib after a confirmed response (PR or better lasting 6 months or longer). In Part A, participants will receive one of two doses of emavusertib BID and an approved dose of zanubrutinib per label. In Part B, additional participants will be enrolled in an expansion if pre-defined criteria for Part A are met. Participants will receive one of two doses of emavusertib BID and an approved dose of zanubrutinib per label.

Primary Outcome Measure

Cohort 1: Undetectable Measurable Residual Disease (uMRD) Rate [ Time Frame: Up to approximately 23 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Mt Sinai Comprehensive Cancer CenterMiami BeachFlorida33140-
Summit Medical GroupFlorham ParkNew Jersey07932-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Texas Oncology - Sammons Cancer CenterDallasTexas75246-

Find similar trials in Miami Beach, FL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Mt Sinai Comprehensive Cancer Center· Miami Beach, FLSummit Medical Group· Florham Park, NJOhio State University Comprehensive Cancer Center· Columbus, OHTexas Oncology - Sammons Cancer Center· Dallas, TX

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