A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

Last updated: July 8, 2025
Sponsor: Kumquat Biosciences Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

KQB365

Cetuximab

Clinical Study ID

NCT06720987
KQB365-101
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are:

  • What is the safe dose of KQB365 by itself or in combination with cetuximab?

  • Does KQB365 alone or in combination with cetuximab decrease the size of the tumor?

  • What happens to KQB365 in the body?

Participants will:

  • Receive KQB365 infusion weekly alone or in combination with cetuximab

  • Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • PART 1 (monotherapy): Histologically confirmed diagnosis of a solid tumor malignancywith either a KRAS G12C or KRAS G12S mutation.

  • PART 1 (combo therapy) & PART 2: Histologically confirmed diagnosis ofadenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation.

  • Unresectable or metastatic disease

  • No available treatment with curative intent

  • Adequate organ function

  • Measurable disease per RECIST v1.1

Exclusion

Exclusion Criteria:

  • Active primary central nervous system tumors

  • Cardiac abnormalities

  • Active interstitial lung disease

Study Design

Total Participants: 128
Treatment Group(s): 2
Primary Treatment: KQB365
Phase: 1
Study Start date:
February 04, 2025
Estimated Completion Date:
June 30, 2030

Connect with a study center

  • Mayo Clinic, Phoenix

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Sarah Cannon Cancer Institute at HealthONE

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Mayo Clinic, Jacksonville

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • START Midwest

    Grand Rapids, Michigan 49546
    United States

    Active - Recruiting

  • Mayo Clinic, Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Cleveland Clinic, Taussig Cancer Institute

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • NEXT Virginia, LLC

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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