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NCT Number: NCT06645886

A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies

The goal of this clinical trial is to learn if KQB198 works to treat advanced hematologic malignancies in adults. It will also learn about the safety of KQB198. The main questions it aims to answer are:

* What is the safe dose of KQB198 by itself or in combination with other anti-cancer drugs? * Does KQB198 alone or in combination with other anti-cancer drugs decrease the size of the tumor? * What happens to KQB198 in the body?

Participants will:

* Take KQB198 daily, alone or in combination with another anti-cancer drug * Visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hematologic Malignancies Adult Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHRU de Tours - Hopital Bretonneau, Tours, Centre-Val de Loire, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adequate organ function

Part 1 and Part 2, Cohort B Participants Only:

  • 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

  • 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

Treatment and study plan

KQB198

Drug

Oral KQB198

dasatinib

Drug

Oral dasatinib

Primary outcomes

  1. Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)

    Time frame: 28 Days

    Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs, and DLTs, from first dose of study treatment to 28 days after last dose of study treatment.

  2. Recommended Phase 2 Dose (RP2D) (Part 1)

    Time frame: Up to 30 months

    Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.

  3. Efficacy of study treatment and optimal biologic dose, as measured by molecular response (MR) per European Leukemia Network (ELN) 2020 Guidelines (Part 2).

    Time frame: Up to 6 Months

    Molecular response is the percentage of BCR-ABL fusion protein found in blood. Calculation of molecular response in Part 2 Cohort A will be the proportion of subjects that experience molecular response 4 (MR4) during the time period from 1st dose of study treatment until 6 months of study treatment. Calculation of molecular response in part 2 cohort B will be the proportion of subjects that experience molecular response 3 (MR3) during the time period from 1st dose of study treatment until 6 months of study treatment.

Secondary outcomes

  1. Efficacy of Study Treatment

    Time frame: Up to 30 months

    Efficacy of study treatment as measured by molecular response (MR) at 3, 6, 9, and 12 months, and anytime.

  2. Efficacy of Study Treatment

    Time frame: Up to 30 Months

    Efficacy of study treatment as measured by duration of response (DOR). DOR is defined as the time from the date when the response is first observed till the date the response is lost or death, whichever is earlier.

  3. Efficacy of Study Treatment

    Time frame: Up to 30 months

    Efficacy of study treatment as measured by time to response (TTR). Response assessments will be summarized by all reported response categories at each visit.

  4. Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 2)

    Time frame: 28 Days After Last Dose

    Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs from first dose of study treatment to 28 days after last dose of study treatment.

  5. Concentration-Time Curve (AUC)

    Time frame: Up to 30 months

  6. Maximum Plasma Concentration (Cmax)

    Time frame: Up to 30 months

  7. Time to Maximum Plasma Concentration (tmax)

    Time frame: Up to 30 months

Sponsors and collaborators

Lead sponsor

Kumquat Biosciences Inc.

Industry

Registry information

Official 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 17, 2024
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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