First in Human Study of UCT-01-097 in Participants With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumor
- Interventions
- Registration Number
- NCT04761601
- Lead Sponsor
- 1200 Pharma, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 32
- Advanced solid tumor
- Measurable disease, per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate organ function
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Finding as Monotherapy - Part 1 UCT-01-097 - Dose Finding in Combination - Part 3 Gemcitabine - Expansion as Monotherapy - Part 2 UCT-01-097 - Dose Finding in Combination - Part 3 UCT-01-097 - Dose Finding in Combination - Part 3 Paclitaxel -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
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
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
Trial Locations
- Locations (6)
Torrance Memorial
🇺🇸Torrance, California, United States
Mary Crowley Cancer Research
🇺🇸Dallas, Texas, United States
Winship Institute of Emory University
🇺🇸Atlanta, Georgia, United States
UCLA - JCCC Clinical Research Unit
🇺🇸Los Angeles, California, United States
Fort Wayne Medical Oncology and Hematology
🇺🇸Fort Wayne, Indiana, United States
Sarah Cannon
🇺🇸Nashville, Tennessee, United States