A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
Recruiting · NCT06720987 · Interventional (participants receive a specific treatment) · Lead sponsor: Kumquat Biosciences Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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, in combination with cetuximab, or in combination with KQB198? * Does KQB365 alone, in combination with cetuximab, or in combination with KQB198 decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone, in combination with cetuximab, or in combination with oral KQB198. * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.
Who can take part
Inclusion criteria
- PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation.
- PART 1 (combo therapy with Cetuximab) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation.
- Unresectable or metastatic disease
- No available treatment with curative intent
- Adequate organ function
- Measurable disease per RECIST v1.1
Exclusion criteria
- Active primary central nervous system tumors
- Cardiac abnormalities
- Active interstitial lung disease
- Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts
Where it is running
11 locations listed across 11 US states.
- 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
- OU Health Stephenson Cancer Center - Oklahoma City, Oklahoma, United States
- Sydney Kimmel Cancer Center - Philadelphia, Pennsylvania, United States
- NEXT Oncology - San Antonio, Texas, United States
- NEXT Virginia, LLC - Fairfax, Virginia, United States