A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
NCT ID: NCT06507306
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2024-06-03
2027-01-31
Brief Summary
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* 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
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Monotherapy Dose Escalation
KQB198
Oral KQB198
Combo Therapy Dose Escalation
KQB198
Oral KQB198
Osimertinib
Oral Osimertinib
Amivantamab
Subcutaneous administration
Combo Therapy Dose Expansion - RP2D
KQB198
Oral KQB198
Osimertinib
Oral Osimertinib
Amivantamab
Subcutaneous administration
Combo Therapy Dose Expansion - RP2D-1
KQB198
Oral KQB198
Osimertinib
Oral Osimertinib
Amivantamab
Subcutaneous administration
Combo Therapy Dose Expansion OBD
KQB198
Oral KQB198
Osimertinib
Oral Osimertinib
Amivantamab
Subcutaneous administration
Interventions
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KQB198
Oral KQB198
Osimertinib
Oral Osimertinib
Amivantamab
Subcutaneous administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* PART 1 - (Osimertinib and Amivantamab arms) and Part 2 Cohort A and Cohort B: Histologically confirmed diagnosis of NSCLC with activating EGFR mutation and progression on osimertinib
* Part 3 - Cohort A: Histologically confirmed diagnosis of NSCLC with exon 20 insertion EGFR mutation
* Unresectable or metastatic disease
* No available treatment with curative intent
* Adequate organ function
* Measurable disease per RECIST 1.1.
Exclusion Criteria
* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
* History of interstitial lung disease
* Cardiac abnormalities
18 Years
ALL
No
Sponsors
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Kumquat Biosciences Inc.
INDUSTRY
Responsible Party
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Locations
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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"
Napoli, , 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, Seoul, South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, 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
Taipei Veterans General Hospital
Taipei, Taiwan, Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KQB198-101
Identifier Type: -
Identifier Source: org_study_id