First in Human Study of UCT-01-097 in Participants With Advanced Solid Tumors
Study Details
Study Description
Brief Summary
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-01-097 in patients with advanced solid tumors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dose Finding as Monotherapy - Part 1
|
Drug: UCT-01-097
Orally available kinase inhibitor
|
| Experimental: Expansion as Monotherapy - Part 2
|
Drug: UCT-01-097
Orally available kinase inhibitor
|
| Experimental: Dose Finding in Combination - Part 3
|
Drug: UCT-01-097
Orally available kinase inhibitor
Drug: Gemcitabine
Gemcitabine injection for intravenous use.
Other Names:
Drug: Paclitaxel
Paclitaxel protein-bound particles for injectable suspension (albumin-bound).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence and severity of adverse events and serious adverse events [up to 2 years]
Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
- Maximum Tolerated Dose (MTD) [28 Days]
Highest administered dose with < 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
- Recommended Phase 2 Dose (RP2D) [up to 2 years]
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Secondary Outcome Measures
- Maximum Plasma UCT-01-097 Concentration (Cmax) [Day 1]
PK assessment for UCT-01-097
- Maximum Plasma UCT-01-097 Concentration at steady state (Cmax,ss) [Day 15]
PK assessment for UCT-01-097
- UCT-01-097 Trough Plasma Concentration (Cmin) [Day 1]
PK assessment for UCT-01-097
- UCT-01-097 Trough Plasma Concentration at Steady State (Cmin,ss) [Day 15]
PK assessment for UCT-01-097
- Time of Maximum Plasma UCT-01-097 Concentration (Tmax) [Cycle 1 (each cycle is 28 days)]
PK assessment for UCT-01-097
- Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of UCT-01-097 [Day 15]
PK assessment for UCT-01-097
- Apparent Clearance (CL/F) of UCT-01-097 [Cycle 1 (each cycle is 28 days)]
PK assessment for UCT-01-097
- Apparent Volume of Distribution (Vz/F) of UCT-01-097 [Cycle 1 (each cycle is 28 days)]
PK assessment for UCT-01-097
- Accumulation Ratio (Rac) of UCT-01-097 [Cycle 1 (each cycle is 28 days)]
PK assessment for UCT-01-097
- Terminal Half-life (t1/2) of UCT-01-097 [Cycle 1 (each cycle is 28 days)]
PK assessment for UCT-01-097
- Objective Response Rate (ORR) [up to 2 years]
Percentage of participants with best response of CR or PR according to RECIST 1.1
- Time to Response (TTR) [up to 2 years]
Time from start of treatment to complete response or partial response
- Duration of Response (DOR) [up to 2 years]
Time from complete response or partial response to objective disease progression or death due to any cause
- Progression Free Survival (PFS) [up to 2 years]
PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause
- 1 Year Overall Survival (1YOS) [1 year]
Proportion of participants alive at 1 year from the start of treatment to death from any cause
- 2 Year Overall Survival (2YOS) [2 years]
Proportion of participants alive at 2 years from the start of treatment to death from any cause
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Advanced solid tumor
-
Measurable disease, per RECIST v1.1
-
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
-
Adequate organ function
Exclusion Criteria:
-
Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
-
Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of UCT-01-097
-
Progressive or symptomatic brain metastases
-
Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
-
History of phosphate or calcium disorder
-
History of significant cardiac disease
-
History or current evidence/risk of retinopathy
-
History of myelodysplastic syndrome (MDS) or AML
-
History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
-
If female, is pregnant or breastfeeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCLA - JCCC Clinical Research Unit | Los Angeles | California | United States | 90095 |
| 2 | Sarah Cannon | Nashville | Tennessee | United States | 37203 |
| 3 | Mary Crowley Cancer Research | Dallas | Texas | United States | 75230 |
Sponsors and Collaborators
- 1200 Pharma, LLC
Investigators
- Study Director: Stephen Letrent, PharmD, PhD, 1200 Pharma, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UCT01097-001