A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
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
1 other identifier
interventional
100
6 countries
35
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2024
Typical duration for phase_1
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 3, 2024
CompletedFirst Submitted
Initial submission to the registry
July 1, 2024
CompletedFirst Posted
Study publicly available on registry
July 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
February 6, 2026
February 1, 2026
2.2 years
July 1, 2024
February 4, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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.
28 Days
Recommended Phase 2 Dose (RP2D) (Part 1)
Evaluate safety and assess number of patients with dose-limiting toxicity to determine the RP2D.
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.
up to 30 months
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (5)
Monotherapy Dose Escalation
EXPERIMENTALCombo Therapy Dose Escalation
EXPERIMENTALCombo Therapy Dose Expansion - RP2D
EXPERIMENTALCombo Therapy Dose Expansion - RP2D-1
EXPERIMENTALCombo Therapy Dose Expansion OBD
EXPERIMENTALInterventions
Oral KQB198
Oral Osimertinib
Subcutaneous administration
Eligibility Criteria
You may qualify if:
- 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 and Amivantamab arms) and Part 2 Cohort A and Cohort B: 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218, United States
Sarah Cannon Research Institute at Florida Cancer Specialists - Lake Nona -
Orlando, Florida, 32827, United States
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
David H. Koch Center for Cancer Center at Memorial Sloan Kettering Cancer Center
Long Island City, New York, 11101, United States
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219, United States
Sarah Cannon and HCA Research Institute
Nashville, Tennessee, 37203, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
New Experimental Therapeutics of San Antonio - NEXT Oncology
San Antonio, Texas, 78229, United States
New Experimental Therapeutics of Virginia - NEXT Oncology
Fairfax, Virginia, 22031, United States
Institut Paoli-Calmettes
Marseille, Bouches-du-Rhône, 13009, France
Institut de Cancerologie de l'Ouest - site St-Herblain
Saint-Herblain, Loire-Atlantique, 44800, France
CHU Bordeaux - Hopital Saint-Andre
Bordeaux, Nouvelle-Aquitane, 33000, France
IUCT-Oncopole
Toulouse, Occitaine, 31059, France
CHU de Nantes - Hopital Nord Laennec
Nantes, Pays de la Loire Region, 44000, France
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, Lazio, 00168, Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Naples, 80131, Italy
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, 06591, South Korea
Hospital Universitari Quiron Dexeus Barcelona
Barcelona, Catalonia, 08028, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Catalonia, 08035, Spain
New Experimental Therapeutics (NEXT) Oncology Barcelona
Barcelona, 08023, Spain
South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos
Barcelona, 08023, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC
Madrid, 28040, Spain
New Experimental Therapeutics (NEXT) Oncology Madrid - Hospital Quironsalud Madrid
Madrid, 28223, Spain
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Madrid, Spain
Hospital Quirónsalud Málaga
Málaga, 29004, Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, 31008, Spain
Chi-Mei Hospital - Liouying Branch
Liuying, Tainan City, 73657, Taiwan
National Taiwan University Hospital
Taipei, Taipei City, 100225, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2024
First Posted
July 18, 2024
Study Start
June 3, 2024
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
January 31, 2027
Last Updated
February 6, 2026
Record last verified: 2026-02