New hope for advanced cancer: KQB198 trial launches
NCT ID NCT06507306
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times
Summary
This early-phase trial tests a new drug called KQB198 in adults with advanced solid tumors that have not responded to other treatments. The study aims to find a safe dose and see if KQB198 can shrink tumors when used alone or with other cancer drugs. About 100 participants will take the drug daily and have regular clinic visits for monitoring.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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92 people
The number who actually took part.
- Started
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Jun 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * PART 1 - Histologically confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations: EGFR, RAS, PTPN11, or SOS1 mutations, or inactivating mutations of NF1. * 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: * Prior therapy with a similar mechanism of action to KQB198 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU Bordeaux - Hopital Saint-Andre
Bordeaux, Nouvelle-Aquitane, 33000, France
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CHU de Nantes - Hopital Nord Laennec
Nantes, Pays de la Loire Region, 44000, France
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Clinica Universidad de Navarra - Pamplona
Pamplona, 31008, Spain
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David H. Koch Center for Cancer Center at Memorial Sloan Kettering Cancer Center
Long Island City, New York, 11101, United States
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Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232, United States
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Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, Lazio, 00168, Italy
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Henry Ford Health System
Detroit, Michigan, 48202, United States
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Hospital Quirónsalud Málaga
Málaga, 29004, Spain
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Hospital Universitari Quiron Dexeus Barcelona
Barcelona, Catalonia, 08028, Spain
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Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
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Hospital Universitario Vall d'Hebron
Barcelona, Catalonia, 08035, Spain
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IUCT-Oncopole
Toulouse, Occitaine, 31059, France
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Institut Paoli-Calmettes
Marseille, Bouches-du-Rhône, 13009, France
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Institut de Cancerologie de l'Ouest - site St-Herblain
Saint-Herblain, Loire-Atlantique, 44800, France
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Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Naples, 80131, Italy
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New Experimental Therapeutics (NEXT) Oncology Barcelona
Barcelona, 08023, Spain
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New Experimental Therapeutics (NEXT) Oncology Madrid - Hospital Quironsalud Madrid
Madrid, 28223, Spain
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New Experimental Therapeutics of San Antonio - NEXT Oncology
San Antonio, Texas, 78229, United States
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New Experimental Therapeutics of Virginia - NEXT Oncology
Fairfax, Virginia, 22031, United States
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Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona -
Orlando, Florida, 32827, United States
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Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218, United States
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Sarah Cannon and HCA Research Institute
Nashville, Tennessee, 37203, United States
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South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos
Barcelona, 08023, Spain
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South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC
Madrid, 28040, Spain
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South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Madrid, Spain
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The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219, United States
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Other studies related to the condition(s) this trial covers.
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- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors