A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
Running, not enrolling · Phase 1
Conditions studied: Solid Tumor, Adult
In brief
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
Key facts
- Study ID
- NCT06507306
- Run by
- Kumquat Biosciences Inc.
- People needed
- 92
- Starts
- 2024-06-03
- Expected to finish
- 2027-01-31
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- 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
- 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
- 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
Full record on ClinicalTrials.gov
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