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

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

Treatments tested in this trial

  • Emavusertib
  • Zanubrutinib

Treatment groups

108 Participants
are divided into 2 treatment groups

Locations

11
Italy
IRCCS Ospedale San Raffaele20132, Milan Italy
Azienda Ospedaliero Universitaria Maggiore Della Carità28100, Novara Italy
Azienda Ospedale Università Padova35128, Padova Italy
Spain
Hospital Universitario Fundación Jiménez Díaz - START MADRID28040, Madrid Spain

Sponsors and collaborators

Curis, Inc.

Lead sponsor