Advanced Solid Tumor
Conditions
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.
Interventions
DRUGUCT-01-097
Orally available kinase inhibitor
DRUGGemcitabine
Gemcitabine injection for intravenous use.
DRUGPaclitaxel
Paclitaxel protein-bound particles for injectable suspension (albumin-bound).
Sponsors
1200 Pharma, LLC
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Maximum Plasma UCT-01-097 Concentration (Cmax) | Day 1 | 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 |
| Terminal Half-life (t1/2) of UCT-01-097 | Cycle 1 (each cycle is 28 days) | 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 |
Countries
United States
Outcome results
None listed