A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB198 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies
Summary
The goal of this clinical trial is to learn if KQB198 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB198. The main questions it aims to answer are: * What is the safe dose of KQB198 by itself or in combination with other anti-cancer drugs? * Does KQB198 alone or in combination with other anti-cancer drugs decrease the size of the tumor? * What happens to KQB198 in the body? Participants will: * Take KQB198 daily, alone or in combination with another anti-cancer drug * Visit the clinic about 8 times in the first 8 weeks, and then once every 4 weeks after that
Arms & interventions
- DrugKQB198
Oral KQB198
- DrugOsimertinib
Oral Osimertinib
- DrugAmivantamab
Subcutaneous administration
Outcome measures
Primary
Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1)
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 28 days after last dose of study treatment.
Time frame: 28 Days
Recommended Phase 2 Dose (RP2D) (Part 1)
Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.
Time frame: up to 30 months
Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Parts 2 and 3)
Objective response is the proportion of subjects that experience confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 during the time period from 1st dose of study treatment until last dose.
Time frame: up to 30 months
Secondary
Concentration-time curve (AUC)
Time frame: up to 30 months
Maximum plasma concentration (Cmax)
Time frame: up to 30 months
Time to maximum plasma concentration (tmax)
Time frame: up to 30 months
Overall survival (OS)
Time frame: up to 30 months
Progression-free survival (PFS)
Time frame: up to 30 months
Overall response rate (ORR)
Time frame: up to 30 months
Duration of response (DOR)
Time frame: up to 30 months
Time to response (TTR)
Time frame: up to 30 months
Eligibility criteria
Study locations (10)
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona -
Orlando, Florida, 32827
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232
Henry Ford Health System
Detroit, Michigan, 48202
David H. Koch Center for Cancer Center at Memorial Sloan Kettering Cancer Center
Long Island City, New York, 11101
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, 37203
MD Anderson Cancer Center
Houston, Texas, 77030
New Experimental Therapeutics of San Antonio - NEXT Oncology
San Antonio, Texas, 78229
New Experimental Therapeutics of Virginia - NEXT Oncology
Fairfax, Virginia, 22031