Actively Recruiting
A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
Led by Kumquat Biosciences Inc. · Updated on 2026-04-23
140
Participants Needed
11
Research Sites
281 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C or KRAS G12S mutation for Part 1 monotherapy and KQB198 combination therapy
- Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with KRAS G12C or KRAS G12S mutation for Part 1 cetuximab combination therapy and Part 2
- Unresectable or metastatic disease
- No available treatment with curative intent
- Adequate organ function
- Measurable disease according to RECIST v1.1
You will not qualify if you...
- Active primary central nervous system tumors
- Cardiac abnormalities
- Active interstitial lung disease
- Unable to swallow or gastrointestinal condition preventing absorption for patients in KQB198 combination cohorts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Mayo Clinic, Phoenix
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Sarah Cannon Cancer Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
3
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
6
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio, United States, 44195
Actively Recruiting
8
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
9
Sydney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
10
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
11
NEXT Virginia, LLC
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
K
Kumquat Clinical Development
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here