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A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
Sponsor: Kumquat Biosciences Inc.
Summary
The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are: * What is the safe dose of KQB365 by itself or in combination with cetuximab? * Does KQB365 alone or in combination with cetuximab decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone or in combination with cetuximab * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.
Official title: A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Optimization Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB365 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2025-02-04
Completion Date
2030-06-30
Last Updated
2025-07-11
Healthy Volunteers
No
Interventions
KQB365
Intravenous KQB365
Cetuximab
Intravenous cetuximab
Locations (9)
Mayo Clinic, Phoenix
Phoenix, Arizona, United States
Sarah Cannon Cancer Institute at HealthONE
Denver, Colorado, United States
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
START Midwest
Grand Rapids, Michigan, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio, United States
NEXT Oncology
San Antonio, Texas, United States
NEXT Virginia, LLC
Fairfax, Virginia, United States