A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies
NCT07542704 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2026-04-21
Summary
The goal of this study is to learn if KQB368 works to treat advanced solid malignancies in adults. The study will also learn about the safety of KQB368. The main questions the study aims to answer are:
* What is the safe dose of KQB368 as a monotherapy?
* Does KQB368 decrease the size of the tumor?
* What happens to KQB368 in the body?
Participants will:
* Take KQB368 orally daily in 21-day cycles
* Return to the study site about 7 times in the first 5 weeks, and then once at the beginning of every 21-day cycle after that
Conditions
- Advanced Solid Tumors
- Colorectal Cancer (CRC)
- Non-Small Cell Lung Cancer
- Uterine Cancer
- KRAS G12C Mutations
- KRAS G12S Mutations
Interventions
- DRUG
-
KQB368
Oral KQB368
Sponsors & Collaborators
-
Worldwide Clinical Trials
collaborator OTHER -
Kumquat Biosciences Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2029-12-31
- Completion
- 2029-12-31
- FDA Drug
- Yes
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