A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
Part of paid clinical trials in Denver, Colorado.
- Sponsor
- Kumquat Biosciences Inc.
- Study ID
- NCT06507306
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Solid Tumor, Adult
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- KQB198 — DRUGOral KQB198
- Osimertinib — DRUGOral Osimertinib
- Amivantamab — DRUGSubcutaneous administration
Study Details
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 Dates
- Start date
- Jun 3, 2024
- Status verified
- Feb 2026
- Primary completion
- Jul 31, 2026
- Completion
- Jan 31, 2027
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Monotherapy Dose Escalation
- Experimental: Combo Therapy Dose Escalation
- Experimental: Combo Therapy Dose Expansion - RP2D
- Experimental: Combo Therapy Dose Expansion - RP2D-1
- Experimental: Combo Therapy Dose Expansion OBD
Primary Outcome Measure
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1) [ Time Frame: 28 Days ]
Central Contacts
- Kumquat Clinical Development(858) 214-2700
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sarah Cannon Research Institute at HealthONE | Denver | Colorado | 80218 | |
| Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona - | Orlando | Florida | 32827 | |
| Florida Cancer Specialists - Sarasota | Sarasota | Florida | 34232 | |
| Henry Ford Health System | Detroit | Michigan | 48202 | |
| David H. Koch Center for Cancer Center at Memorial Sloan Kettering Cancer Center | Long Island City | New York | 11101 | Navkaran Singh |
| The Lindner Center for Research and Education at The Christ Hospital | Cincinnati | Ohio | 45219 | |
| Sarah Cannon and HCA Research Institute | Nashville | Tennessee | 37203 | |
| MD Anderson Cancer Center | Houston | Texas | 77030 | - |
| New Experimental Therapeutics of San Antonio - NEXT Oncology | San Antonio | Texas | 78229 | Steven Alvarado |
| New Experimental Therapeutics of Virginia - NEXT Oncology | Fairfax | Virginia | 22031 |
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