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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy Dose Escalation | Experimental | Drug: KQB168 - Oral KQB168 |
|
| Combo Therapy Dose Escalation | Experimental | Drug: KQB168 - Oral KQB168 Drug: pembrolizumab - Intravenous pembrolizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KQB168 | Drug | Oral KQB168 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Using RECIST v1.1 | up to 36 months |
| Duration of response (DOR) | Using RECIST v1.1 | up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kumquat Clinical Development | Contact | (858) 214-2700 | kumquatstudies@kumquatbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic - Phoenix | Recruiting | Phoenix | Arizona | 85054 | United States |
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| Pembrolizumab |
| Drug |
Intravenous pembrolizumab |
|
| Time to response (TTR) | Using RECIST v1.1 | up to 36 months |
| Disease control rate (DCR) | Using RECIST v1.1 | up to 36 months |
| Progression-free survival (PFS) | Using RECIST v1.1 | up to 36 months |
| Overall survival (OS) | using RECIST v1.1 | up to 36 months |
| 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) | Assessment of tumor and systemic immune activation | up to 36 months |
| USC Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | United States |
|
| Sarah Cannon Cancer Institute at HealthONE | Recruiting | Denver | Colorado | 80218 | United States |
|
| Yale Cancer Center- New Haven | Recruiting | New Haven | Connecticut | 06520 | United States |
|
| Mayo Clinic - Jacksonville | Recruiting | Jacksonville | Florida | 32224 | United States |
|
| Florida Cancer Specialists - Sarasota | Recruiting | Sarasota | Florida | 34232 | United States |
|
| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
|
| Mayo Clinic - Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| NEXT Austin | Recruiting | Austin | Texas | 78758 | United States |
|
| Mary Crowley Cancer Research Centers | Recruiting | Dallas | Texas | 75230 | United States |
|
| UT MD Anderson Cancer Center - Houston | Recruiting | Houston | Texas | 77030 | United States |
|
| NEXT Huston | Recruiting | Houston | Texas | 77054 | United States |
|
| NEXT Oncology | Recruiting | San Antonio | Texas | 78229 | United States |
|
| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
|
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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