Solid Tumor Malignancies
Conditions
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
Interventions
DRUGKQB168
Oral KQB168
DRUGPembrolizumab
Intravenous pembrolizumab
Sponsors
Kumquat Biosciences Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | up to 36 months | Using RECIST v1.1 |
| Duration of response (DOR) | up to 36 months | Using RECIST v1.1 |
| Time to response (TTR) | up to 36 months | Using RECIST v1.1 |
| 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 |
Countries
United States
Contacts
CONTACTKumquat Clinical Development
Outcome results
None listed