Emavusertib for Chronic lymphocytic leukemia | B-cell malignancies

Inclusion criteria

• {"criterion_text":"- 1. Age ≥18 years of age with life expectancy of ≥ 3 months.\n- 10. For Cohort 1 only: Patient must be in a PR or PR-L and MRD+, must have detectable MRD as determined by the ClonoSEQ assay, actively taking zanubrutinib for at least 12 months, acceptable organ function (protocol-defined) at Screening within 28 days prior to Cycle 1 Day 1 (C1D1)\n- 11. For Cohort 2 only: Relapsed disease (protocol-defined) for which patients are ineligible for or exhausted standard of care options; Actively taking zanubrutinib and with direct progression on zanubrutinib and no other anticancer therapy administered since; Acceptable organ function (protocol-defined) at Screening within 28 days prior to C1D1.\n- 2. Eastern Cooperative Oncology Group Performance Status of ≤2;\n- 3. Histopathologically confirmed diagnosis of CLL per the World Health Organization 2016 classification;\n- 4. At least 1 criterion for measurable disease per iwCLL; creatine phosphokinase (CPK) < 2.5 × upper limit of normal (ULN);\n- 5. Ability to tolerate contrast-enhanced computed tomography (CT) scan;\n- 6. Ability to swallow/retain oral medications;\n- 7. Negative serum pregnancy test in women of childbearing potential (WOCP);\n- 8. WOCP and men who partner with WOCP must use highly effective contraceptive methods during study and 180 days after the last dose of study treatment;\n- 9. Ability to understand/sign a written informed consent document."}

Exclusion criteria

• {"criterion_text":"- 1. Active second malignancy unless in remission with life expectancy > 2 years;\n- 10.\tHistory of Stevens-Johnson syndrome or toxic epidermal necrolysis;\n- 11.\tIntolerance to contrast-enhanced CT scan: Major surgery < 28 days prior to C1D1, minor surgery < 7 days prior to C1D1. Viral infections (protocol-defined);\n- 12.\tConcomitant illness that would preclude safe participation in the study.\n- 2. Active malignancy other than CLL requiring systemic therapy;\n- 3. high-risk CLL TP53 mutations and 17P deletion;\n- 4. History of Grade ≥ 3 rhabdomyolysis without complete recovery;\n- 5. Prior chimeric antigen receptor-T cell therapy;\n- 6. Prior investigational drugs within 28 days or 5 half-lives, whichever is shorter, prior to C1D1: allogeneic hematopoietic stem cell transplant (HSCT) within 60 days prior to C1D1, or clinically significant graft-versus-host disease (GVHD) requiring ongoing uptitration of immunosuppressive medications prior to Screening: Prior systemic anticancer treatment received within 21 days or 5 half-lives, whichever is shorter, prior to C1D1 (with the exception of zanubrutinib, which may be continued until the day before C1D1);\n- 7.\tReceiving the following medications within 7 days or 5 half-lives, whichever is shorter, prior to C1D1: Medications that have a high risk of causing prolonged QT interval, corrected (QTc) and/or Torsades de Pointes, Peg-filgrastim or equivalent, St John’s Wort;\n- 8.\tHistory of or ongoing drug-induced pneumonitis, History of stroke or intracranial hemorrhage within 6 months prior to C1D1, Requirement for anticoagulation with warfarin or equivalent vitamin K antagonists, including dual antiplatelet agents, within 5 half-lives of the anticoagulant or 7 days, whichever is longer, prior to C1D1;\n- 9.\tVaccinated with a live-attenuated vaccine within 4 weeks prior to C1D1: History of hypersensitivity or anaphylaxis to ema, approved BTKi, or any of their excipients;"}

Primary endpoints

• {"endpoint_text":"- 1.\tCohort 1: undetectable measurable residual disease (uMRD) rate: percentage of patients achieving uMRD as measured in peripheral blood mononuclear cells (PBMCs) by the ClonoSEQ assay. Bone marrow aspirate is required to confirm a CR and uMRD by peripheral blood.","definition_or_measurement_approach":"uMRD measured in PBMCs by the ClonoSEQ assay; bone marrow aspirate required to confirm a CR and uMRD measured in peripheral blood."}
• {"endpoint_text":"- 2.\tCohort 2: ORR: percentage of patients achieving a complete response (CR), or PR using iwCLL Response Criteria guidelines (Hallek et al, 2018)","definition_or_measurement_approach":"Overall response rate (ORR) assessed using iwCLL Response Criteria (Hallek et al., 2018), counting CR and PR per those guidelines."}

Secondary endpoints

• {"endpoint_text":"- 1.\tCohort 1: Duration of uMRD, Time to measurable residual disease (MRD) conversion, complete response (CR) rate, Duration of CR, Time to CR","definition_or_measurement_approach":"Duration and time-to-events relating to uMRD and CR as measured by ClonoSEQ and iwCLL criteria per protocol-defined schedules."}
• {"endpoint_text":"- 2.\tCohort 2: Duration of response (DOR), Time to response","definition_or_measurement_approach":"DOR and time-to-response assessed per iwCLL Response Criteria and protocol definitions."}
• {"endpoint_text":"- 3.\tCohort 1 and Cohort 2: •\tProgression-free survival (PFS), Overall survival (OS) •\tIncidence of treatment-emergent adverse events (TEAEs) and treatment-related AEs, physical examinations, vital signs, electrocardiograms (ECGs), and laboratory values •\tPK parameters: Cmax, Tmax, AUC0-t, and Cmin for emavusertib and zanubrutinib","definition_or_measurement_approach":"PFS and OS measured from treatment start per protocol definitions; safety assessed by incidence of TEAEs and treatment-related AEs using standard AE reporting; PK parameters (Cmax, Tmax, AUC0-t, Cmin) for emavusertib and zanubrutinib measured from plasma samples per PK schedule."}

Italy

Earliest CTIS Part Ii Submission Date

16-02-2026

Latest Decision Or Authorization Date

16-03-2026

Processing Time Days

28

Number Of Sites

3

Number Of Participants

20

Spain

Earliest CTIS Part Ii Submission Date

11-02-2026

Latest Decision Or Authorization Date

16-03-2026

Processing Time Days

33

Number Of Sites

2

Number Of Participants

20

Primary sponsor

Full Name

Curis Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Suvoda LLC

Responsibilities

sponsorDuties codes: [14, 3]

Name

Icon Clinical Research Limited

Responsibilities

sponsorDuties codes: [4]

Name

Icon Laboratory Services Inc.

Responsibilities

sponsorDuties codes: [4]

Name

Syneos Health Inc.

Responsibilities

sponsorDuties codes: [1, 11, 12, 13, 5]

Name

Fortrea Inc.

Responsibilities

sponsorDuties codes: [8]

Third parties

• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: [14, 3]","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Neogenomics Laboratories Inc. (Houston)","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Q-Square Business Intelligence Corp.","duties_or_roles":"sponsorDuties codes: [6, 7]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Northeast Bioanalytical Laboratories LLC","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties codes: [8]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: [1, 11, 12, 13, 5]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Neogenomics Laboratories Inc. (Aliso Viejo)","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bostongene Corp.","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Pharmaceutical company"}