NCT07542704RecruitingPhase 1
A Study to Investigate the Safety and Efficacy of KQB368 as Monotherapy in Participants With Advanced Solid Malignancies
A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB368 in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 13 Apr 2026
- Start date
- 27 May 2026
- Primary completion date
- Dec 2029
- Lead sponsor
- Kumquat Biosciences Inc.
- Diseases
- Lung cancer, Colorectal cancer
- NCT number
- NCT07542704
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 48
- From 27 May 2026 to the primary completion date, Dec 2029
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Histologically confirmed diagnosis of a solid tumor
- Malignancy 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
- Must be able to swallow with no GI condition that prevents absorption
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NEXT Oncology - Austin Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| UH Cleveland Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| START Dallas- Fort Worth Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| NEXT Oncology- Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| John Theurer Cancer Center At Hackensack UMC Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| START - Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Providence Cancer Institute Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| University of Utah - Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| START | San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.