KQB168 alone or with pembrolizumab for adults with advanced solid tumors
A Phase 1, Open-label, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB168 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Malignancies
This will test whether daily KQB168, alone or together with pembrolizumab, can shrink tumors and is safe for adults with advanced solid cancers that have progressed after prior immunotherapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kumquat Biosciences Inc. Industry-sponsored |
| Drugs / interventions | immunotherapy, pembrolizumab |
| Locations | 15 sites (Phoenix, Arizona and 14 other locations) |
| Trial ID | NCT06994806 on ClinicalTrials.gov |
What this trial studies
This Phase 1, dose-finding trial gives daily oral KQB168 either by itself or combined with pembrolizumab to adults with unresectable or metastatic solid tumors. The study escalates or adjusts doses to identify a safe and tolerable dose, monitors adverse events, measures tumor size by RECIST v1.1, and collects blood samples to study pharmacokinetics. Participants visit the clinic about eight times in the first eight weeks and then every three weeks for ongoing treatment and monitoring. Primary goals are safety, tolerability, how the drug behaves in the body, and preliminary evidence of tumor response.
Who should consider this trial
Good fit: Adults with histologically confirmed unresectable or metastatic solid tumors that have progressed on prior immunotherapy, with measurable disease and adequate organ function, represent the ideal candidates.
Not a fit: Patients with active primary central nervous system tumors, significant cardiac or lung disease, uncontrolled autoimmune conditions, problems with oral drug absorption, or those who have potentially curative treatment options are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, KQB168 could become a new option that shrinks or controls tumors in patients whose advanced solid cancers no longer respond to prior immunotherapy.
How similar studies have performed: Combining novel oral agents with pembrolizumab has produced responses in some early-phase studies for certain cancers, but KQB168 itself is experimental and has limited prior human data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed diagnosis of solid tumor malignancy. * Unresectable or metastatic disease that has progressed on immunotherapy. * 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 * History of lung diseases * Any condition that may impair drug absorption or prevent oral dosing * Known history of immune-mediated colitis and uncontrolled autoimmune diseases
Where this trial is running
Phoenix, Arizona and 14 other locations
- Mayo Clinic - Phoenix — Phoenix, Arizona, United States (Recruiting)
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- Sarah Cannon Cancer Institute at HealthONE — Denver, Colorado, United States (Recruiting)
- Yale Cancer Center- New Haven — New Haven, Connecticut, United States (Recruiting)
- Mayo Clinic - Jacksonville — Jacksonville, Florida, United States (Recruiting)
- Florida Cancer Specialists - Sarasota — Sarasota, Florida, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- Mayo Clinic - Rochester — Rochester, Minnesota, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- NEXT Austin — Austin, Texas, United States (Recruiting)
- Mary Crowley Cancer Research Centers — Dallas, Texas, United States (Recruiting)
- UT MD Anderson Cancer Center - Houston — Houston, Texas, United States (Recruiting)
- NEXT Huston — Houston, Texas, United States (Recruiting)
- NEXT Oncology — San Antonio, Texas, United States (Recruiting)
- NEXT Virginia — 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.