Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Translational Research in Oncology | OTHER |
Not provided
Not provided
Not provided
Not provided
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-03-008 in patients with advanced solid tumors.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Finding as Monotherapy - Part 1 | Experimental | UCT-03-008 Dose Finding |
|
| Expansion as Monotherapy - Part 2 | Experimental | UCT-03-008 RP2D Expansion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCT-03-008 | Drug | Orally available kinase inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events and serious adverse events | Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0 | up to 2 years |
| Maximum Tolerated Dose (MTD) | Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants | 28 Days |
| Recommended Phase 2 Dose (RP2D) | Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma UCT-03-008 Concentration following single dose (Cmax) | PK assessment for UCT-03-008 | Cycle 0(each cycle is 28 days) |
| Maximum Plasma UCT-03-008 Concentration at steady state (Cmax,ss) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Garcia | Contact | 213-5197493 | AGarcia@trio-us.org |
| Name | Affiliation | Role |
|---|---|---|
| Alex Garcia | TRIO-US | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA - JCCC Clinical Research Unit | Recruiting | Los Angeles | California | 90095 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
PK assessment for UCT-03-008
| Cycle 1 (each cycle is 28 days) |
| Minimum Plasma UCT-03-008 Concentration following single dose (Cmin) | PK assessment for UCT-003-008 | Cycle 0 (each cycle is 28 days) |
| Minimum Plasma UCT-03-008 Concentration at steady state (Cmin,ss) | PK assessment for UCT-003-008 | Cycle 1 (each cycle is 28 days) |
| Time of Maximum Plasma UCT-03-008 Concentration following single dose (Tmax) | PK assessment for UCT-03-008 | Cycle 0 (each cycle is 28 days) |
| Time of Maximum Plasma UCT-03-008 Concentration at steady state (Tmax,ss) | PK assessment for UCT-03-008 | Cycle 0 (each cycle is 28 days) |
| Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of UCT-03-008 | PK assessment for UCT-03-008 | Cycle 0 (each cycle is 28 days) |
| Area Under the Plasma Concentration-Time Curve from the time of dosing to the last measurable concentration (AUClast) of UCT-03-008 | PK assessment for UCT-03-008 | Cycle 0 (each cycle is 28 days) |
| Apparent Clearance (CL/F) of UCT-03-008 | PK assessment for UCT-03-008 | Cycle 0 (each cycle is 28 days) |
| Apparent Volume of Distribution (Vz/F) of UCT-03-008 | PK assessment for UCT-03-008 | Cycle 0 (each cycle is 28 days) |
| Terminal Half-life (t1/2) of plasma UCT-03-008 | PK assessment for UCT-03-008 | Cycle 1 (each cycle is 28 days) |
| Objective Response Rate (ORR) | Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1 | up to 2 years |
| Time to Response (TTR) | Time from start of treatment to complete response or partial response | up to 2 years |
| Duration of Response (DOR) | Time from complete response or partial response to objective disease progression or death due to any cause | up to 2 years |
| Progression Free Survival (PFS) | PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause | up to 2 years |
| 1 Year Overall Survival (1YOS) | Proportion of participants alive at 1 year from the start of treatment to death from any cause | 1 year |
| 2 Year Overall Survival (2YOS) | Proportion of participants alive at 2 years from the start of treatment to death from any cause | 2 years |
| Torrance Memorial | Terminated | Torrance | California | 90505 | United States |
| Winship Institute of Emory University | Terminated | Atlanta | Georgia | 30322 | United States |
| Mary Crowley Cancer Research | Recruiting | Dallas | Texas | 75230 | United States |
|
| START (South Texas Accelerated Research Therapeutics) | Terminated | San Antonio | Texas | 78229 | United States |