A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
- Conditions
- Solid Tumor Malignancies
- Interventions
- Drug: KQB168
- Registration Number
- NCT06994806
- Lead Sponsor
- Kumquat Biosciences Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 84
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Monotherapy Dose Escalation KQB168 Drug: KQB168 - Oral KQB168 Combo Therapy Dose Escalation KQB168 Drug: KQB168 - Oral KQB168 Drug: pembrolizumab - Intravenous pembrolizumab Combo Therapy Dose Escalation Pembrolizumab Drug: KQB168 - Oral KQB168 Drug: pembrolizumab - Intravenous pembrolizumab
- Primary Outcome Measures
Name Time Method Number of patients who experience treatment-emergent adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) up to 36 months 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.
- Secondary Outcome Measures
Name Time Method Disease control rate (DCR) up to 36 months Using RECIST v1.1
Progression-free survival (PFS) up to 36 months Using RECIST v1.1
Overall survival (OS) up to 36 months using RECIST v1.1
Concentration-time curve (AUC) up to 36 months Maximum plasma concentration (Cmax) up to 36 months Time to maximum plasma concentration (tmax) up to 36 months Pharmacologically Active Dose (PAD) up to 36 months Assessment of tumor and systemic immune activation
Time to response (TTR) up to 36 months Using RECIST v1.1
Overall response rate (ORR) up to 36 months Using RECIST v1.1
Duration of response (DOR) up to 36 months Using RECIST v1.1