Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
This is a non-randomised, open-label trial with two experimental cohorts. Experimental Cohort 1 is made up of participants with relapsed or refractory diffuse large B-cell lymphoma, and Experimental Cohort 2 is made up of relapsed or refractory chronic lymphocytic leukaemia. Both cohorts will receive KRT-232 and Acalabrutinib. KRT-232 will be administered orally, once daily, on days 1-7 in a 28-day cycle. Acalabrutinib will be administered 100mg, twice daily, continuously starting on Day 1 in a 28-day cycle.
Conditions
This trial is treating people with relapsed or refractory diffuse large B-cell lymphoma and chronic lymphocytic leukaemia
Eligibility
Inclusion
- Cohort 1: Confirmed diagnosis of TP53wt DLBCL (WHO); R/R DLBCL after at least 2 prior lines of treatment or 1 prior for patients who are ineligible for stem cell transplant
- Cohort 2: Confirmed diagnosis of TP53wt CLL (iwCLL); R/R CLL after at least 1 prior line of treatment
- ECOG 0 to 2
- Adequate hematologic, hepatic, and renal functions.
Exclusion
- Prior treatment with any MDM2 inhibitor
- Prior treatment with any BTK inhibitor
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
Exclusion
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Kartos Therapeutics, Inc.
Scientific Title
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma or Relapsed/Refractory Chronic Lymphocytic Leukemia
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