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
Summary
The goal of this clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are: * What is the safe dose of KQB168 by itself or in combination with pembrolizumab? * Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor? * What happens to KQB168 in the body? Participants will: * Take KQB168 daily, alone or in combination with pembrolizumab * Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after that
Arms & interventions
- DrugKQB168
Oral KQB168
- DrugPembrolizumab
Intravenous pembrolizumab
Outcome measures
Primary
Number of patients who experience treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, SAEs, and DLTs, from first dose of study treatment to 30 days after last dose of study treatment.
Time frame: up to 36 months
Secondary
Overall response rate (ORR)
Time frame: up to 36 months
Duration of response (DOR)
Time frame: up to 36 months
Time to response (TTR)
Time frame: up to 36 months
Disease control rate (DCR)
Time frame: up to 36 months
Progression-free survival (PFS)
Time frame: up to 36 months
Overall survival (OS)
Time frame: up to 36 months
Concentration-time curve (AUC)
Time frame: up to 36 months
Maximum plasma concentration (Cmax)
Time frame: up to 36 months
Time to maximum plasma concentration (tmax)
Time frame: up to 36 months
Pharmacologically Active Dose (PAD)
Time frame: up to 36 months
Eligibility criteria
Study locations (15)
Mayo Clinic - Phoenix
Phoenix, Arizona, 85054
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Sarah Cannon Cancer Institute at HealthONE
Denver, Colorado, 80218
Yale Cancer Center- New Haven
New Haven, Connecticut, 06520
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232
University of Iowa
Iowa City, Iowa, 52242
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Cleveland Clinic
Cleveland, Ohio, 44195
NEXT Austin
Austin, Texas, 78758
Mary Crowley Cancer Research Centers
Dallas, Texas, 75230
UT MD Anderson Cancer Center - Houston
Houston, Texas, 77030
NEXT Huston
Houston, Texas, 77054
NEXT Oncology
San Antonio, Texas, 78229
NEXT Virginia
Fairfax, Virginia, 22031