Description:
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and
antitumor activity of UCT-01-097 in patients with advanced solid tumors.
Title
- Brief Title: First in Human Study of UCT-01-097 in Participants With Advanced Solid Tumors
- Official Title: A Phase 1, First in Human, Dose-Escalation Study of UCT-01-097 in Participants With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
UCT01097-001
- NCT ID:
NCT04761601
Conditions
Interventions
Drug | Synonyms | Arms |
---|
UCT-01-097 | | Dose Finding as Monotherapy - Part 1 |
Gemcitabine | Gemzar | Dose Finding in Combination - Part 3 |
Paclitaxel | Abraxane | Dose Finding in Combination - Part 3 |
Purpose
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and
antitumor activity of UCT-01-097 in patients with advanced solid tumors.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Finding as Monotherapy - Part 1 | Experimental | | |
Expansion as Monotherapy - Part 2 | Experimental | | |
Dose Finding in Combination - Part 3 | Experimental | | - UCT-01-097
- Gemcitabine
- Paclitaxel
|
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-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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence and severity of adverse events and serious adverse events |
Time Frame: | up to 2 years |
Safety Issue: | |
Description: | Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0 |
Secondary Outcome Measures
Measure: | Maximum Plasma UCT-01-097 Concentration (Cmax) |
Time Frame: | Day 1 |
Safety Issue: | |
Description: | PK assessment for UCT-01-097 |
Measure: | Maximum Plasma UCT-01-097 Concentration at steady state (Cmax,ss) |
Time Frame: | Day 15 |
Safety Issue: | |
Description: | PK assessment for UCT-01-097 |
Measure: | UCT-01-097 Trough Plasma Concentration (Cmin) |
Time Frame: | Day 1 |
Safety Issue: | |
Description: | PK assessment for UCT-01-097 |
Measure: | UCT-01-097 Trough Plasma Concentration at Steady State (Cmin,ss) |
Time Frame: | Day 15 |
Safety Issue: | |
Description: | PK assessment for UCT-01-097 |
Measure: | Time of Maximum Plasma UCT-01-097 Concentration (Tmax) |
Time Frame: | Cycle 1 (each cycle is 28 days) |
Safety Issue: | |
Description: | PK assessment for UCT-01-097 |
Measure: | Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of UCT-01-097 |
Time Frame: | Day 15 |
Safety Issue: | |
Description: | PK assessment for UCT-01-097 |
Measure: | Apparent Clearance (CL/F) of UCT-01-097 |
Time Frame: | Cycle 1 (each cycle is 28 days) |
Safety Issue: | |
Description: | PK assessment for UCT-01-097 |
Measure: | Apparent Volume of Distribution (Vz/F) of UCT-01-097 |
Time Frame: | Cycle 1 (each cycle is 28 days) |
Safety Issue: | |
Description: | PK assessment for UCT-01-097 |
Measure: | Accumulation Ratio (Rac) of UCT-01-097 |
Time Frame: | Cycle 1 (each cycle is 28 days) |
Safety Issue: | |
Description: | PK assessment for UCT-01-097 |
Measure: | Terminal Half-life (t1/2) of UCT-01-097 |
Time Frame: | Cycle 1 (each cycle is 28 days) |
Safety Issue: | |
Description: | PK assessment for UCT-01-097 |
Measure: | Objective Response Rate (ORR) |
Time Frame: | up to 2 years |
Safety Issue: | |
Description: | Percentage of participants with best response of CR or PR according to RECIST 1.1 |
Measure: | Time to Response (TTR) |
Time Frame: | up to 2 years |
Safety Issue: | |
Description: | Time from start of treatment to complete response or partial response |
Measure: | Duration of Response (DOR) |
Time Frame: | up to 2 years |
Safety Issue: | |
Description: | Time from complete response or partial response to objective disease progression or death due to any cause |
Measure: | Progression Free Survival (PFS) |
Time Frame: | up to 2 years |
Safety Issue: | |
Description: | PFS is defined as the time from the start of the treatment until objective disease progression or death from any cause |
Measure: | 1 Year Overall Survival (1YOS) |
Time Frame: | 1 year |
Safety Issue: | |
Description: | Proportion of participants alive at 1 year from the start of treatment to death from any cause |
Measure: | 2 Year Overall Survival (2YOS) |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Proportion of participants alive at 2 years from the start of treatment to death from any cause |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | 1200 Pharma, LLC |
Last Updated
March 30, 2021