Clinical Trials /

First in Human Study of UCT-01-097 in Participants With Advanced Solid Tumors

NCT04761601

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

  • Advanced Solid Tumor

Interventions

DrugSynonymsArms
UCT-01-097Dose Finding as Monotherapy - Part 1
GemcitabineGemzarDose Finding in Combination - Part 3
PaclitaxelAbraxaneDose 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

NameTypeDescriptionInterventions
Dose Finding as Monotherapy - Part 1Experimental
  • UCT-01-097
Expansion as Monotherapy - Part 2Experimental
  • UCT-01-097
Dose Finding in Combination - Part 3Experimental
  • 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:Not yet recruiting
Lead Sponsor:1200 Pharma, LLC

Last Updated

February 21, 2021