Clinical Trial 23307

• Overview

  Study Title:

  A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of KQB198 as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Hematologic Malignancies

  Summary:

  The purpose of this clinical trial is to determine if KQB198 works to treat advanced hematologic malignancies in adults.

  Objective:

  Primary Objectives: Part 1: To determine the safety, tolerability, and RP2D of KQB198 as monotherapy and in combination with dasatinib. Part 2, Cohort A: To evaluate the efficacy of KQB198 in combination with dasatinib and determine the OBD.' Part 2, Cohort B: To evaluate the efficacy of KQB198 monotherapy and determine the OBD. Secondary Objectives: Part 1: To evaluate the efficacy of KQB198 as monotherapy and in combination with dasatinib. Part 2, Cohorts A and B: To evaluate the efficacy of KQB198 monotherapy and in combination with dasatinib. All Parts: To evaluate the safety and tolerability of KQB198 as monotherapy and in combination with dasatinib. All Parts: To evaluate the plasma pharmacokinetics (PK) of KQB198 alone or KQB198 and dasatinib when administered in combination.

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  Dasatinib (BMS-354825); KQB198 ()

• Inclusion Criteria

  Inclusion Criteria:
  • Adequate Organ Function Part 1 and Part 2, Cohort B Participants Only:
  • Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) in chronic phase who have been previously treated with at least 2 different tyrosine kinase inhibitors (TKIs) and are relapsed from or intolerant to those TKIs and ineligible for alternative therapeutic options likely to produce clinical benefit as determined by the investigator. Part 2, Cohort A Participants Only:
  • Participants with Ph+ CML in chronic phase who are on dasatinib prior to study entry and have a warning or failure to dasatinib as determined by the investigator per ELN 2020 guidelines

• Exclusion Criteria

  Exclusion Criteria:
  • Chronic myelogenous leukemia (CML) in accelerated or blast phase
  • Prior therapy with a similar mechanism of action to KQB198
  • History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
  • History of interstitial lung disease
  • Cardiac abnormalities

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