Clinical trial NCT05103046: First in Human Study of UCT-03-008 in Participants With Advanced Solid Tumors
Official title: A Phase 1, First in Human, Dose-Escalation Study of UCT-03-008 in Participants With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: 1200 Pharma, LLC
Sponsor class: INDUSTRY
Collaborators: name: Translational Research in Oncology
First posted: 2021-11-02
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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-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

Primary outcomes:
measure: Incidence and severity of adverse events and serious adverse events
timeFrame: up to 2 years
measure: Maximum Tolerated Dose (MTD)
timeFrame: 28 Days
measure: Recommended Phase 2 Dose (RP2D)
timeFrame: up to 2 years
Secondary outcomes:
measure: Maximum Plasma UCT-03-008 Concentration following single dose (Cmax)
timeFrame: Cycle 0(each cycle is 28 days)
measure: Maximum Plasma UCT-03-008 Concentration at steady state (Cmax,ss)
timeFrame: Cycle 1 (each cycle is 28 days)
measure: Minimum Plasma UCT-03-008 Concentration following single dose (Cmin)
timeFrame: Cycle 0 (each cycle is 28 days)
measure: Minimum Plasma UCT-03-008 Concentration at steady state (Cmin,ss)
timeFrame: Cycle 1 (each cycle is 28 days)
measure: Time of Maximum Plasma UCT-03-008 Concentration following single dose (Tmax)
timeFrame: Cycle 0 (each cycle is 28 days)
measure: Time of Maximum Plasma UCT-03-008 Concentration at steady state (Tmax,ss)
timeFrame: Cycle 0 (each cycle is 28 days)
measure: Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of UCT-03-008
timeFrame: Cycle 0 (each cycle is 28 days)
measure: Area Under the Plasma Concentration-Time Curve from the time of dosing to the last measurable concentration (AUClast) of UCT-03-008
timeFrame: Cycle 0 (each cycle is 28 days)
measure: Apparent Clearance (CL/F) of UCT-03-008
timeFrame: Cycle 0 (each cycle is 28 days)
measure: Apparent Volume of Distribution (Vz/F) of UCT-03-008
timeFrame: Cycle 0 (each cycle is 28 days)
measure: Terminal Half-life (t1/2) of plasma UCT-03-008
timeFrame: Cycle 1 (each cycle is 28 days)
measure: Objective Response Rate (ORR)
timeFrame: up to 2 years
measure: Time to Response (TTR)
timeFrame: up to 2 years
measure: Duration of Response (DOR)
timeFrame: up to 2 years
measure: Progression Free Survival (PFS)
timeFrame: up to 2 years
measure: 1 Year Overall Survival (1YOS)
timeFrame: 1 year
measure: 2 Year Overall Survival (2YOS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA - JCCC Clinical Research Unit
state: California
city: Torrance
country: United States
facility: Torrance Memorial
state: California
city: Atlanta
country: United States
facility: Winship Institute of Emory University
state: Georgia
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: San Antonio
country: United States
facility: START (South Texas Accelerated Research Therapeutics)
state: Texas
Study officials:
affiliation: TRIO-US
name: Alex Garcia
role: STUDY_DIRECTOR
References: