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

Last updated: October 31, 2025
Sponsor: Kumquat Biosciences Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

osimertinib

KQB198

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: osimertinib
Phase: 1
Study Start date:
June 03, 2024
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Institut Paoli-Calmettes

    Marseille, Bouches-du-Rhône 13009
    France

    Site Not Available

  • Institut Paoli-Calmettes

    Marseille 2995469, Bouches-du-Rhône 13009
    France

    Active - Recruiting

  • Institut de Cancerologie de l'Ouest - site St-Herblain

    Saint-Herblain, Loire-Atlantique 44800
    France

    Site Not Available

  • Institut de Cancerologie de l'Ouest - site St-Herblain

    Saint-Herblain 2979590, Loire-Atlantique 44800
    France

    Active - Recruiting

  • CHU Bordeaux - Hopital Saint-Andre

    Bordeaux, Nouvelle-Aquitane 33000
    France

    Site Not Available

  • CHU Bordeaux - Hopital Saint-Andre

    Bordeaux 3031582, Nouvelle-Aquitane 33000
    France

    Active - Recruiting

  • IUCT-Oncopole

    Toulouse, Occitaine 31059
    France

    Site Not Available

  • IUCT-Oncopole

    Toulouse 2972315, Occitaine 31059
    France

    Active - Recruiting

  • CHU de Nantes - Hopital Nord Laennec

    Nantes, Pays De La Loire 44000
    France

    Site Not Available

  • CHU de Nantes - Hopital Nord Laennec

    Nantes 2990969, Pays de la Loire Region 2988289 44000
    France

    Active - Recruiting

  • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

    Roma, Lazio 00168
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

    Rome 3169070, Lazio 3174976 00168
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori

    Napoli, 80131
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

    Napoli, 80131
    Italy

    Site Not Available

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

    Napoli 9031661, 80131
    Italy

    Active - Recruiting

  • National Cancer Center

    Goyang-si, Gyeonggi-do 10408
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do 58128
    Korea, Republic of

    Site Not Available

  • Seoul St. Mary's Hospital, The Catholic University of Korea

    Seoul, 06591
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Goyang-si 1842485, Gyeonggi-do 1841610 10408
    South Korea

    Active - Recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun 1843841, Jeollanam-do 1845788 58128
    South Korea

    Active - Recruiting

  • Seoul St. Mary's Hospital, The Catholic University of Korea

    Seoul 1835848, Seoul 1835847 06591
    South Korea

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, Seoul 1835847 03722
    South Korea

    Active - Recruiting

  • Hospital Universitari Quiron Dexeus Barcelona

    Barcelona, Catalonia 08028
    Spain

    Active - Recruiting

  • Hospital Universitari Quiron Dexeus Barcelona

    Barcelona 3128760, Catalonia 3336901 08028
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona 3128760, Catalonia 3336901 08035
    Spain

    Active - Recruiting

  • New Experimental Therapeutics (NEXT) Oncology Barcelona

    Barcelona, 08023
    Spain

    Site Not Available

  • Next Oncology Barcelona

    Barcelona, 08023
    Spain

    Active - Recruiting

  • START Barcelona- HM Nou Delfos

    Barcelona, 08023
    Spain

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos

    Barcelona, 08023
    Spain

    Active - Recruiting

  • New Experimental Therapeutics (NEXT) Oncology Barcelona

    Barcelona 3128760, 08023
    Spain

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos

    Barcelona 3128760, 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

  • New Experimental Therapeutics (NEXT) Oncology Madrid - Hospital Quironsalud Madrid

    Madrid, 28223
    Spain

    Site Not Available

  • START Madrid - CIOCC

    Madrid, 28050
    Spain

    Active - Recruiting

  • START Madrid - Hospital Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC

    Madrid, 28040
    Spain

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid 3117735, 28034
    Spain

    Active - Recruiting

  • New Experimental Therapeutics (NEXT) Oncology Madrid - Hospital Quironsalud Madrid

    Madrid 3117735, 28223
    Spain

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz

    Madrid 3117735,
    Spain

    Active - Recruiting

  • Hospital Quirónsalud Málaga

    Malaga, 29004
    Spain

    Site Not Available

  • Hospital Quirónsalud Málaga

    Málaga 2514256, 29004
    Spain

    Active - Recruiting

  • Clínica Universidad de Navarra - Hospital

    Navarra, 31008
    Spain

    Site Not Available

  • Clinica Universidad de Navarra - Pamplona

    Pamplona, 31008
    Spain

    Site Not Available

  • Clinica Universidad de Navarra - Pamplona

    Pamplona 3114472, 31008
    Spain

    Active - Recruiting

  • Chi-Mei Hospital - Liouying Branch

    Liuying, Tainan City 73657
    Taiwan

    Site Not Available

  • Chi-Mei Hospital - Liouying Branch

    Liuying 1672665, Tainan City 73657
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, Taipei City 100225
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei 1668341, Taipei City 100225
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei 1668341, Taiwan 7280291 11217
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung 1668399, 40705
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado 80218
    United States

    Site Not Available

  • Sarah Cannon Research Institute at HealthONE

    Denver 5419384, Colorado 5417618 80218
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    Orlando, Florida 32827
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona -

    Orlando, Florida 32827
    United States

    Site Not Available

  • Florida Cancer Specialists

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Florida Cancer Specialists - Sarasota

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona -

    Orlando 4167147, Florida 4155751 32827
    United States

    Active - Recruiting

  • Florida Cancer Specialists - Sarasota

    Sarasota 4172131, Florida 4155751 34232
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit 4990729, Michigan 5001836 48202
    United States

    Active - Recruiting

  • David H. Koch Center for Cancer Center at Memorial Sloan Kettering Cancer Center

    Long Island City, New York 11101
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    Long Island City, New York 11101
    United States

    Active - Recruiting

  • David H. Koch Center for Cancer Center at Memorial Sloan Kettering Cancer Center

    Long Island City 5125125, New York 5128638 11101
    United States

    Active - Recruiting

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

    Cincinnati, Ohio 45219
    United States

    Site Not Available

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

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Sarah Cannon and HCA Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Sarah Cannon and HCA Research Institute

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • New Experimental Therapeutics of San Antonio - NEXT Oncology

    San Antonio, Texas 78229
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • New Experimental Therapeutics of San Antonio - NEXT Oncology

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • NEXT Oncology

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • New Experimental Therapeutics of Virginia - NEXT Oncology

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • New Experimental Therapeutics of Virginia - NEXT Oncology

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.