NCT06720987RecruitingPhase 1
A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Optimization Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB365 as Monotherapy and in Combination With Anti-cancer Agents 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 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 3 Dec 2024
- Start date
- 4 Feb 2025
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Kumquat Biosciences Inc.
- Diseases
- Lung cancer, Colorectal cancer
- NCT number
- NCT06720987
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 140
- From 4 Feb 2025 to the primary completion date, 30 Jun 2029
- 11 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.
Other illness
- Cardiac abnormalities
- Active interstitial lung disease
- Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts
Other
- Active primary central nervous system tumors
Who the study is looking for
- 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.
- PART 1 (monotherapy Non-Small Cell Lung Cancer Cohort): Histologically confirmed diagnosis of Non-Small Cell Lung Cancer 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Cleveland Clinic Taussig Cancer Institute Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Sarah Cannon Cancer Institute at HealthONE Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| NEXT Virginia, LLC Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| START | Midwest Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| OU Health Stephenson Cancer Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Sydney Kimmel Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Mayo Clinic Phoenix Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| NEXT Oncology 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.