KQB368 Phase 1 Study for Advanced Solid Cancers
Summary
A Phase 1 clinical trial (NCT07542704) evaluating KQB368 as an oral monotherapy for adults with advanced solid malignancies including colorectal, non-small cell lung, and uterine cancers. The study will assess safe dosing, tumor response, and pharmacokinetics in 21-day cycles. The trial is registered on ClinicalTrials.gov with no new regulatory requirements imposed.
What changed
A new Phase 1 clinical trial registration for KQB368 (NCT07542704) has been recorded on ClinicalTrials.gov. The trial will evaluate KQB368 as an oral daily monotherapy across 21-day cycles in participants with advanced solid malignancies. Conditions under study include colorectal cancer, non-small cell lung cancer, uterine cancer, and KRAS G12C/G12S mutations.
Pharmaceutical companies and clinical investigators conducting oncology drug development should note this early-phase trial entry for compliance tracking purposes. ClinicalTrials.gov registrations are informational records and do not create new regulatory obligations beyond existing trial conduct requirements.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies
Phase 1 NCT07542704 Kind: PHASE1 Apr 21, 2026
Abstract
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: KQB368
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