Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06507306

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

Led by Kumquat Biosciences Inc. · Updated on 2026-02-06

100

Participants Needed

35

Research Sites

138 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older with advanced solid tumor cancer
  • Histologically confirmed solid tumor with mutations in EGFR, RAS, PTPN11, SOS1, or NF1
  • NSCLC with activating EGFR mutation and progression on osimertinib (for certain study arms)
  • NSCLC with exon 20 insertion EGFR mutation (for specific cohort)
  • Disease that is unresectable or metastatic
  • No available treatments with curative intent
  • Adequate organ function
  • Measurable disease according to RECIST 1.1 criteria
Not Eligible

You will not qualify if you...

  • Prior treatment with drugs having a similar mechanism as KQB198
  • History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal issues that affect drug absorption or swallowing
  • History of interstitial lung disease
  • Cardiac abnormalities

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 35 locations

1

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States, 80218

Actively Recruiting

2

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

Orlando, Florida, United States, 32827

Actively Recruiting

3

Florida Cancer Specialists - Sarasota

Sarasota, Florida, United States, 34232

Actively Recruiting

4

Henry Ford Health System

Detroit, Michigan, United States, 48202

Actively Recruiting

5

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

Long Island City, New York, United States, 11101

Actively Recruiting

6

The Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio, United States, 45219

Actively Recruiting

7

Sarah Cannon and HCA Research Institute

Nashville, Tennessee, United States, 37203

Actively Recruiting

8

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Withdrawn

9

New Experimental Therapeutics of San Antonio - NEXT Oncology

San Antonio, Texas, United States, 78229

Actively Recruiting

10

New Experimental Therapeutics of Virginia - NEXT Oncology

Fairfax, Virginia, United States, 22031

Actively Recruiting

11

Institut Paoli-Calmettes

Marseille, Bouches-du-Rhône, France, 13009

Actively Recruiting

12

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

Saint-Herblain, Loire-Atlantique, France, 44800

Actively Recruiting

13

CHU Bordeaux - Hopital Saint-Andre

Bordeaux, Nouvelle-Aquitane, France, 33000

Actively Recruiting

14

IUCT-Oncopole

Toulouse, Occitaine, France, 31059

Actively Recruiting

15

CHU de Nantes - Hopital Nord Laennec

Nantes, Pays de la Loire Region, France, 44000

Actively Recruiting

16

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

Rome, Lazio, Italy, 00168

Actively Recruiting

17

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

Naples, Italy, 80131

Actively Recruiting

18

National Cancer Center

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

Withdrawn

19

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea, 58128

Withdrawn

20

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Withdrawn

21

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

Seoul, South Korea, 06591

Withdrawn

22

Hospital Universitari Quiron Dexeus Barcelona

Barcelona, Catalonia, Spain, 08028

Actively Recruiting

23

Hospital Universitario Vall d'Hebron

Barcelona, Catalonia, Spain, 08035

Actively Recruiting

24

New Experimental Therapeutics (NEXT) Oncology Barcelona

Barcelona, Spain, 08023

Actively Recruiting

25

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

Barcelona, Spain, 08023

Actively Recruiting

26

Hospital Universitario Ramon y Cajal

Madrid, Spain, 28034

Actively Recruiting

27

South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC

Madrid, Spain, 28040

Actively Recruiting

28

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

Madrid, Spain, 28223

Actively Recruiting

29

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

Madrid, Spain

Actively Recruiting

30

Hospital Quirónsalud Málaga

Málaga, Spain, 29004

Actively Recruiting

31

Clinica Universidad de Navarra - Pamplona

Pamplona, Spain, 31008

Actively Recruiting

32

Chi-Mei Hospital - Liouying Branch

Liuying, Tainan City, Taiwan, 73657

Withdrawn

33

National Taiwan University Hospital

Taipei, Taipei City, Taiwan, 100225

Withdrawn

34

Taichung Veterans General Hospital

Taichung, Taiwan, 40705

Withdrawn

35

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

Withdrawn

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Research Team

K

Kumquat Clinical Development

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

5

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