A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
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
1 other identifier
interventional
84
1 country
15
Brief 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
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 2025
Typical duration for phase_1
15 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
First Submitted
Initial submission to the registry
May 12, 2025
CompletedFirst Posted
Study publicly available on registry
May 29, 2025
CompletedStudy Start
First participant enrolled
June 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
March 3, 2026
February 1, 2026
2.4 years
May 12, 2025
February 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
up to 36 months
Secondary Outcomes (10)
Overall response rate (ORR)
up to 36 months
Duration of response (DOR)
up to 36 months
Time to response (TTR)
up to 36 months
Disease control rate (DCR)
up to 36 months
Progression-free survival (PFS)
up to 36 months
- +5 more secondary outcomes
Study Arms (2)
Monotherapy Dose Escalation
EXPERIMENTALDrug: KQB168 - Oral KQB168
Combo Therapy Dose Escalation
EXPERIMENTALDrug: KQB168 - Oral KQB168 Drug: pembrolizumab - Intravenous pembrolizumab
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Mayo Clinic - Phoenix
Phoenix, Arizona, 85054, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Sarah Cannon Cancer Institute at HealthONE
Denver, Colorado, 80218, United States
Yale Cancer Center- New Haven
New Haven, Connecticut, 06520, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34232, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
NEXT Austin
Austin, Texas, 78758, United States
Mary Crowley Cancer Research Centers
Dallas, Texas, 75230, United States
UT MD Anderson Cancer Center - Houston
Houston, Texas, 77030, United States
NEXT Huston
Houston, Texas, 77054, United States
NEXT Oncology
San Antonio, Texas, 78229, United States
NEXT Virginia
Fairfax, Virginia, 22031, United States
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
May 12, 2025
First Posted
May 29, 2025
Study Start
June 24, 2025
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
May 31, 2028
Last Updated
March 3, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share