First in Human Study of UCT-03-008 in Participants With Advanced Solid Tumors
- Registration Number
- NCT05103046
- Lead Sponsor
- 1200 Pharma, LLC
- Brief Summary
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-03-008 in patients with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 68
- 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-03-008
- Progressive or symptomatic brain metastases
- Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
- 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-03-008 UCT-03-008 Dose Finding Expansion as Monotherapy - Part 2 UCT-03-008 UCT-03-008 RP2D Expansion
- Primary Outcome Measures
Name Time Method Recommended Phase 2 Dose (RP2D) up to 2 years Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Maximum Tolerated Dose (MTD) 28 Days Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants
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
- Secondary Outcome Measures
Name Time Method Maximum Plasma UCT-03-008 Concentration following single dose (Cmax) Cycle 0(each cycle is 28 days) PK assessment for UCT-03-008
Time of Maximum Plasma UCT-03-008 Concentration following single dose (Tmax) Cycle 0 (each cycle is 28 days) PK assessment for UCT-03-008
Apparent Clearance (CL/F) of UCT-03-008 Cycle 0 (each cycle is 28 days) PK assessment for UCT-03-008
Apparent Volume of Distribution (Vz/F) of UCT-03-008 Cycle 0 (each cycle is 28 days) PK assessment for UCT-03-008
Area Under the Plasma Concentration-Time Curve from the time of dosing to the last measurable concentration (AUClast) of UCT-03-008 Cycle 0 (each cycle is 28 days) PK assessment for UCT-03-008
Minimum Plasma UCT-03-008 Concentration following single dose (Cmin) Cycle 0 (each cycle is 28 days) PK assessment for UCT-003-008
Terminal Half-life (t1/2) of plasma UCT-03-008 Cycle 1 (each cycle is 28 days) PK assessment for UCT-03-008
2 Year Overall Survival (2YOS) 2 years Proportion of participants alive at 2 years from the start of treatment to death from any cause
Minimum Plasma UCT-03-008 Concentration at steady state (Cmin,ss) Cycle 1 (each cycle is 28 days) PK assessment for UCT-003-008
Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of UCT-03-008 Cycle 0 (each cycle is 28 days) PK assessment for UCT-03-008
Maximum Plasma UCT-03-008 Concentration at steady state (Cmax,ss) Cycle 1 (each cycle is 28 days) PK assessment for UCT-03-008
Time of Maximum Plasma UCT-03-008 Concentration at steady state (Tmax,ss) Cycle 0 (each cycle is 28 days) PK assessment for UCT-03-008
Objective Response Rate (ORR) up to 2 years Percentage of participants with best response of complete response (CR) or partial response (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
Trial Locations
- Locations (5)
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
Torrance Memorial
🇺🇸Torrance, California, United States
START (South Texas Accelerated Research Therapeutics)
🇺🇸San Antonio, Texas, United States