Status:
RECRUITING
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
Lead Sponsor:
Kumquat Biosciences Inc.
Conditions:
Solid Tumor, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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: * ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06507306
Start Date
June 3 2024
End Date
January 31 2027
Last Update
December 16 2025
Active Locations (35)
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1
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
2
Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona -
Orlando, Florida, United States, 32827
3
Florida Cancer Specialists - Sarasota
Sarasota, Florida, United States, 34232
4
Henry Ford Health System
Detroit, Michigan, United States, 48202