A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KQB168, Pembrolizumab.
- Who it may be relevant to
- Registry conditions: Solid Tumor Malignancies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Interventions
- Drug KQB168
Oral KQB168 - Drug Pembrolizumab
Intravenous pembrolizumab
Primary outcome measures
- Number of patients who experience treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) [Time frame: up to 36 months]
Secondary outcome measures (10)
- 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
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 15 centers
- Mayo Clinic - Phoenix — Phoenix
- USC Norris Comprehensive Cancer Center — Los Angeles
- Sarah Cannon Cancer Institute at HealthONE — Denver
- Yale Cancer Center- New Haven — New Haven
- Mayo Clinic - Jacksonville — Jacksonville
- Florida Cancer Specialists - Sarasota — Sarasota
- University of Iowa — Iowa City
- Mayo Clinic - Rochester — Rochester
- … and 7 more centers
Identifiers
NCT: NCT06994806 · KQB168-101