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

ConditionsChronic Lymphocytic LeukemiaB-cell Malignancies
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCuris, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and females ≥ 18 years of age.

Life expectancy of ≥ 3 months.

Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2.

Histopathologically confirmed diagnosis of CLL (medical record is acceptable), as per the World Health Organization 2016 classification.

Disqualifiers

Active second malignancy unless in remission with a life expectancy of > 2 years and with documented Sponsor approval.

Active malignancy other than CLL requiring systemic therapy (exceptions may be granted following a discussion with the Sponsor Medical Monitor).

Have high-risk CLL TP53 mutations and 17P deletion.

History of Grade ≥ 3 rhabdomyolysis without complete recovery.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Emavusertib

    Drug

    Oral tablets

  • Zanubrutinib

    Drug

    Oral capsules

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Cohort 1: Emavusertib and ZanubrutinibExperimental treatment 2 interventions
Group B: Cohort 2: Emavusertib and ZanubrutinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Cohort 1: Undetectable Measurable Residual Disease (uMRD) Rate

Time frame
Up to approximately 23 months
2

Cohort 2: Overall Response Rate (ORR)

Time frame
Up to approximately 23 months

Secondary outcomes

1

Cohort 1: Duration of uMRD

Time frame
Up to approximately 23 months
2

Cohort 1: Time to Measurable Residual Disease (MRD) Conversion

Time frame
Up to approximately 23 months
3

Cohort 1: Complete Response (CR) Rate

Time frame
Up to approximately 23 months
4

Cohort 1: Duration of CR

Time frame
Up to approximately 23 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Curis, Inc.

Lead sponsor

Source ClinicalTrials.gov
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