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A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
Sponsor: Kumquat Biosciences Inc.
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
Official 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 Anti-cancer Agents in Participants With Advanced Solid Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-06-03
Completion Date
2027-01-31
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
KQB198
Oral KQB198
Osimertinib
Oral Osimertinib
Amivantamab
Subcutaneous administration
Locations (35)
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona -
Orlando, Florida, United States
Florida Cancer Specialists - Sarasota
Sarasota, Florida, United States
Henry Ford Health System
Detroit, Michigan, United States
David H. Koch Center for Cancer Center at Memorial Sloan Kettering Cancer Center
Long Island City, New York, United States
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
New Experimental Therapeutics of San Antonio - NEXT Oncology
San Antonio, Texas, United States
New Experimental Therapeutics of Virginia - NEXT Oncology
Fairfax, Virginia, United States
Institut Paoli-Calmettes
Marseille, Bouches-du-Rhône, France
Institut de Cancerologie de l'Ouest - site St-Herblain
Saint-Herblain, Loire-Atlantique, France
CHU Bordeaux - Hopital Saint-Andre
Bordeaux, Nouvelle-Aquitane, France
IUCT-Oncopole
Toulouse, Occitaine, France
CHU de Nantes - Hopital Nord Laennec
Nantes, Pays de la Loire Region, France
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, Lazio, Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Naples, Italy
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, South Korea
Hospital Universitari Quiron Dexeus Barcelona
Barcelona, Catalonia, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Catalonia, Spain
New Experimental Therapeutics (NEXT) Oncology Barcelona
Barcelona, Spain
South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos
Barcelona, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC
Madrid, Spain
New Experimental Therapeutics (NEXT) Oncology Madrid - Hospital Quironsalud Madrid
Madrid, Spain
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Madrid, Spain
Hospital Quirónsalud Málaga
Málaga, Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, Spain
Chi-Mei Hospital - Liouying Branch
Liuying, Tainan City, Taiwan
National Taiwan University Hospital
Taipei, Taipei City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan