Investigating KQB365 for treating advanced solid tumors
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
This study tests if a new treatment called KQB365, alone or with another drug, can help adults with advanced solid tumors that have specific genetic mutations.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kumquat Biosciences Inc. Industry-sponsored |
| Drugs / interventions | Cetuximab |
| Locations | 11 sites (Phoenix, Arizona and 10 other locations) |
| Trial ID | NCT06720987 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of KQB365, both as a standalone treatment and in combination with cetuximab, for adults with advanced solid tumors harboring KRAS G12C or G12S mutations. Participants will receive weekly infusions of KQB365 and will undergo regular clinic visits to monitor their health and tumor response. The study will assess the safe dosage of KQB365, its effectiveness in reducing tumor size, and how the drug behaves in the body.
Who should consider this trial
Good fit: Ideal candidates include adults with unresectable or metastatic solid tumors that have KRAS G12C or G12S mutations.
Not a fit: Patients with active primary central nervous system tumors, significant cardiac abnormalities, or active interstitial lung disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that currently have limited treatment options.
How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * Unresectable or metastatic disease * No available treatment with curative intent * Adequate organ function * Measurable disease per RECIST v1.1 Exclusion Criteria: * Active primary central nervous system tumors * Cardiac abnormalities * Active interstitial lung disease * Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts
Where this trial is running
Phoenix, Arizona and 10 other locations
- Mayo Clinic, Phoenix — Phoenix, Arizona, United States (Recruiting)
- Sarah Cannon Cancer Institute at HealthONE — Denver, Colorado, United States (Recruiting)
- Mayo Clinic, Jacksonville — Jacksonville, Florida, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- START Midwest — Grand Rapids, Michigan, United States (Recruiting)
- Mayo Clinic, Rochester — Rochester, Minnesota, United States (Recruiting)
- Cleveland Clinic, Taussig Cancer Institute — Cleveland, Ohio, United States (Recruiting)
- OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (Recruiting)
- Sydney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
- NEXT Oncology — San Antonio, Texas, United States (Recruiting)
- NEXT Virginia, LLC — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Kumquat Clinical Development
- Email: kumquatstudies@kumquatbio.com
- Phone: (858) 214-2700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.