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

Last updated: December 23, 2024
Sponsor: Kumquat Biosciences Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

KQB198

osimertinib

Clinical Study ID

NCT06507306
KQB198-101
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to learn if KQB198 works to treat advanced solid tumor cancer 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • PART 1: Histologically confirmed diagnosis of a solid tumor malignancy with any ofthe following oncogenic mutations: EGFR, RAS, PTPN11, or SOS1 mutations, orinactivating mutations of NF1.

  • PART 1 (Osimertinib arm) and Part 2 Cohort A: Histologically confirmed diagnosis ofNSCLC with activating EGFR mutation and progression on osimertinib

  • Part 3 Cohort A: Histologically confirmed diagnosis of NSCLC with exon 20 insertionEGFR mutation

  • Unresectable or metastatic disease

  • No available treatment with curative intent

  • Adequate organ function

  • Measurable disease per RECIST 1.1.

Exclusion

Exclusion Criteria:

  • Prior therapy with a similar mechanism of action to KQB198

  • History of intestinal disease, inflammatory bowel disease, major gastric surgery, orother gastrointestinal conditions likely to alter absorption of study treatment orresult in inability to swallow

  • History of interstitial lung disease

  • Cardiac abnormalities

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: KQB198
Phase: 1
Study Start date:
June 03, 2024
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Istituto Nazionale Tumori

    Napoli, 80131
    Italy

    Active - Recruiting

  • Next Oncology Barcelona

    Barcelona, 08023
    Spain

    Active - Recruiting

  • START Barcelona- HM Nou Delfos

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Active - Recruiting

  • NEXT Oncology Madrid- Hospital Quironsalud Madrid

    Madrid, 28223
    Spain

    Active - Recruiting

  • START Madrid - CIOCC

    Madrid, 28050
    Spain

    Active - Recruiting

  • START Madrid - Hospital Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Quirónsalud Málaga

    Malaga, 29004
    Spain

    Active - Recruiting

  • Clínica Universidad de Navarra - Hospital

    Navarra, 31008
    Spain

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    Orlando, Florida 32827
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    Long Island City, New York 11101
    United States

    Active - Recruiting

  • The Lindner Center for Research and Education at The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • NEXT Oncology

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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