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Recruiting NCT04502394

Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL

Phase I / Phase II Interventional Diffuse Large B Cell Lymphoma Chronic Lymphocytic Leukemia Non Hodgkin Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KRT-232, acalabrutinib.
Who it may be relevant to
Registry conditions: Diffuse Large B Cell Lymphoma, Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Belgium, Czechia, France +6
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, combined with acalabrutinib for the treatment of adults with Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia. Participants must be relapsed/refractory (having failed prior therapy)

Interventions

  • Drug KRT-232
    KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth
  • Drug acalabrutinib
    acalabrutinib is a BTK inhibitor anticancer drug taken by mouth

Primary outcome measures

  • Primary Objective Phase 1b:To determine the KRT-232 maximum tolerated dose/ maximum administered dose (MTD/MAD) and recommended Phase 2 Dose (RP2D) in combination with acalabrutinib in subjects with R/R DLBCL or R/R CLL [Time frame: 56 Days]
  • Primary Objective Phase 2: Cohort 1: To determine the complete response (CR) [Time frame: 1 Year]
  • Primary Objective Phase 2: Cohort 2: To determine the rate of CR/complete remission with incomplete hematologic recovery (CRi) rate in R/R CLL [Time frame: 1 Year]
Secondary outcome measures (7)
  • Phase 1b Secondary Objective: Pharmacokinetic (PK) profile [Time frame: Baseline, 1, 2, 4, 6 and 24 hours post dose on days 1 and 2 of cycle 1 (each cycle is 28 days); Baseline and 2 hours post dose on day 1 and 24 hours post dose on day 8 of cycle 2]
  • Phase 1b Secondary Objective: Pharmacokinetic (PK) profile [Time frame: Baseline, 1, 2, 4, 6 and 24 hours post dose on days 1 and 2 of cycle 1 (each cycle is 28 days); Baseline and 2 hours post dose on day 1 and 24 hours post dose on day 8 of cycle 2]
  • Phase 1b Secondary Objective: Pharmacokinetic (PK) profile [Time frame: Baseline, 1, 2, 4, 6 and 24 hours post dose on days 1 and 2 of cycle 1 (each cycle is 28 days); Baseline and 2 hours post dose on day 1 and 24 hours post dose on day 8 of cycle 2]
  • Phase 1b Secondary Objective: Pharmacokinetic (PK) profile [Time frame: Baseline, 1, 2, 4, 6 and 24 hours post dose on days 1 and 2 of cycle 1 (each cycle is 28 days); Baseline and 2 hours post dose on day 1 and 24 hours post dose on day 8 of cycle 2]
  • Phase 1b Secondary Objective: Pharmacokinetic (PK) profile [Time frame: Baseline, 1, 2, 4, 6 and 24 hours post dose on days 1 and 2 of cycle 1 (each cycle is 28 days); Baseline and 2 hours post dose on day 1 and 24 hours post dose on day 8 of cycle 2]
  • Phase 2 Secondary Objective: Cohort 1 (R/R DLBCL): To determine the overall response rate (ORR) for R/R DLBCL subjects. [Time frame: 2 Years]
  • Phase 2 Secondary Objective: Cohort 2 (R/R CLL): To determine the ORR for R/R CLL subjects [Time frame: 2 Years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • Prior treatment with any MDM2 inhibitor
  • Prior treatment with any BTK inhibitor

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 6 centers
  • Centro Riferimento Oncologico - Aviano — Aviano
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori — Meldola
  • ASST Grande Ospedale Metropolitano Niguarda — Milan
  • IRCCS Ospedale San Raffaele — Milan
  • Fondazione IRCCS Policlinico San Matteo — Pavia
  • Centro Ricerche Cliniche di Verona s.r.l. — Verona
Poland · 6 centers
  • Copernicus PL Sp. z o.o., Wojewodzkie Centrum Onkologii — Gdansk
  • Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii — Gdansk
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Od — Gliwice
  • Pratia MCM Krakow — Krakow
  • Szpital Uniwersytecki Krakow - Oddzial Kliniczny Hematologii — Krakow
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu — Wroclaw
South Korea · 6 centers
  • National Cancer Center — Goyang
  • Gachon University Gil Medical Center — Incheon
  • Samsung Medical Center — Seoul
  • Seoul National University Hospital — Seoul
  • Seoul St. Mary's Hospital — Seoul
  • Severance Hospital, Yonsei University Health System — Seoul
Portugal · 5 centers
  • Hospital de Braga — Braga
  • Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria — Lisbon
  • Champalimaud Cancer Center — Lisbon
  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE — Porto
  • Centro Hospitalar de Vila Nova de Gaia/Espinho EPE — Vila Nova de Gaia
United States · 4 centers
  • Goshen Center for Cancer Care — Goshen
  • University of Cincinnati — Cincinnati
  • The Ohio State University Comprehensive Cancer Center — Columbus
  • UT Southwestern Medical Center — Dallas
Australia · 4 centers
  • Royal Adelaide Hospital — Adelaide
  • Eastern Health - Box Hill Hospital — Box Hill
  • Barwon Health — Geelong
  • Royal Perth Hospital — Perth
United Kingdom · 4 centers
  • St James's University Hospital — Leeds
  • King's College Hospital — London
  • Royal Marsden Foundation Trust — London
  • University Hospital Southampton NHS Foundation Trust — Southampton
Belgium · 3 centers
  • Antwerp University Hospital (UZA) — Edegem
  • Jessa Ziekenhuis — Hasselt
  • University Hospital (UZ) Leuven — Leuven
Czechia · 3 centers
  • Fakultni Nemocnice Hradec Kralove — Nový Hradec Králové
  • Fakultni nemocnice Ostrava — Ostrava
  • Vseobecna fakultni nemocnice v Praze — Prague
France · 3 centers
  • CHU de Nantes - Hôtel-Dieu — Nantes
  • Centre Henri Becquerel — Rouen
  • CHRU de Tours - Hôpital Bretonneau — Tours
Switzerland · 1 center
  • Kantonsspital St. Gallen — Sankt Gallen

Identifiers

NCT: NCT04502394 · KRT-232-111

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗