A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
- Registration Number
- NCT06507306
- Lead Sponsor
- Kumquat Biosciences Inc.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- PART 1: Histologically confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations: EGFR, RAS, PTPN11, or SOS1 mutations, or inactivating mutations of NF1.
- PART 1 (Osimertinib arm) and Part 2 Cohort A: Histologically confirmed diagnosis of NSCLC with activating EGFR mutation and progression on osimertinib
- Part 3 Cohort A: Histologically confirmed diagnosis of NSCLC with exon 20 insertion EGFR mutation
- Unresectable or metastatic disease
- No available treatment with curative intent
- Adequate organ function
- Measurable disease per RECIST 1.1.
- Prior therapy with a similar mechanism of action to KQB198
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow
- History of interstitial lung disease
- Cardiac abnormalities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Monotherapy Dose Escalation KQB198 - Combo Therapy Dose Escalation KQB198 - Combo Therapy Dose Expansion - RP2D KQB198 - Combo Therapy Dose Expansion - RP2D-1 KQB198 - Combo Therapy Dose Expansion - RP2D-1 osimertinib - Combo Therapy Dose Expansion OBD osimertinib - Combo Therapy Dose Expansion OBD KQB198 - Combo Therapy Dose Expansion - RP2D osimertinib - Combo Therapy Dose Escalation osimertinib -
- Primary Outcome Measures
Name Time Method Number of patients who experience treatment-emergent adverse events, serious adverse events, and dose-limiting toxicities (Part 1) 28 Days 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.
Recommended Phase 2 Dose (RP2D) (Part 1) up to 30 months Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.
Efficacy and Optimal Biologic Dose of study treatment, as measured by Objective Response Rate (ORR) (Parts 2 and 3) up to 30 months 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.
- Secondary Outcome Measures
Name Time Method Concentration-time curve (AUC) up to 30 months Maximum plasma concentration (Cmax) up to 30 months Time to maximum plasma concentration (tmax) up to 30 months Overall survival (OS) up to 30 months Progression-free survival (PFS) up to 30 months Overall response rate (ORR) up to 30 months Duration of response (DOR) up to 30 months Time to response (TTR) up to 30 months
Trial Locations
- Locations (34)
Sarah Cannon Research Institute at HealthONE
🇺🇸Denver, Colorado, United States
Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona -
🇺🇸Orlando, Florida, United States
Florida Cancer Specialists - Sarasota
🇺🇸Sarasota, Florida, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
David H. Koch Center for Cancer Center at Memorial Sloan Kettering Cancer Center
🇺🇸Long Island City, New York, United States
The Lindner Center for Research and Education at The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Sarah Cannon and HCA Research Institute
🇺🇸Nashville, Tennessee, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
New Experimental Therapeutics of San Antonio - NEXT Oncology
🇺🇸San Antonio, Texas, United States
New Experimental Therapeutics of Virginia - NEXT Oncology
🇺🇸Fairfax, Virginia, United States
Institut Paoli-Calmettes
🇫🇷Marseille, Bouches-du-Rhône, France
Institut de Cancerologie de l'Ouest - site St-Herblain
🇫🇷Saint-Herblain, Loire-Atlantique, France
CHU Bordeaux - Hopital Saint-Andre
🇫🇷Bordeaux, Nouvelle-Aquitane, France
IUCT-Oncopole
🇫🇷Toulouse, Occitaine, France
CHU de Nantes - Hopital Nord Laennec
🇫🇷Nantes, Pays De La Loire, France
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
🇮🇹Roma, Lazio, Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
🇮🇹Napoli, Italy
National Cancer Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Jeollanam-do, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
Hospital Universitari Quiron Dexeus Barcelona
🇪🇸Barcelona, Catalonia, Spain
New Experimental Therapeutics (NEXT) Oncology Barcelona
🇪🇸Barcelona, Spain
South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos
🇪🇸Barcelona, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC
🇪🇸Madrid, Spain
New Experimental Therapeutics (NEXT) Oncology Madrid - Hospital Quironsalud Madrid
🇪🇸Madrid, Spain
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital Quirónsalud Málaga
🇪🇸Malaga, Spain
Clinica Universidad de Navarra - Pamplona
🇪🇸Pamplona, Spain
Chi-Mei Hospital - Liouying Branch
🇨🇳Liuying, Tainan City, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taipei City, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan