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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04761601
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
1200 Pharma, LLC

Tracking Information
First Submitted Date  ICMJE February 16, 2021
First Posted Date  ICMJE February 21, 2021
Last Update Posted Date March 30, 2021
Actual Study Start Date  ICMJE March 3, 2021
Estimated Primary Completion Date September 23, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2021)
  • Incidence and severity of adverse events and serious adverse events [ Time Frame: up to 2 years ]
    Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0
  • Maximum Tolerated Dose (MTD) [ Time Frame: 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) [ Time Frame: up to 2 years ]
    Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2021)
  • Maximum Plasma UCT-01-097 Concentration (Cmax) [ Time Frame: Day 1 ]
    PK assessment for UCT-01-097
  • Maximum Plasma UCT-01-097 Concentration at steady state (Cmax,ss) [ Time Frame: Day 15 ]
    PK assessment for UCT-01-097
  • UCT-01-097 Trough Plasma Concentration (Cmin) [ Time Frame: Day 1 ]
    PK assessment for UCT-01-097
  • UCT-01-097 Trough Plasma Concentration at Steady State (Cmin,ss) [ Time Frame: Day 15 ]
    PK assessment for UCT-01-097
  • Time of Maximum Plasma UCT-01-097 Concentration (Tmax) [ Time Frame: 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 [ Time Frame: Day 15 ]
    PK assessment for UCT-01-097
  • Apparent Clearance (CL/F) of UCT-01-097 [ Time Frame: Cycle 1 (each cycle is 28 days) ]
    PK assessment for UCT-01-097
  • Apparent Volume of Distribution (Vz/F) of UCT-01-097 [ Time Frame: Cycle 1 (each cycle is 28 days) ]
    PK assessment for UCT-01-097
  • Accumulation Ratio (Rac) of UCT-01-097 [ Time Frame: Cycle 1 (each cycle is 28 days) ]
    PK assessment for UCT-01-097
  • Terminal Half-life (t1/2) of UCT-01-097 [ Time Frame: Cycle 1 (each cycle is 28 days) ]
    PK assessment for UCT-01-097
  • Objective Response Rate (ORR) [ Time Frame: up to 2 years ]
    Percentage of participants with best response of CR or PR according to RECIST 1.1
  • Time to Response (TTR) [ Time Frame: up to 2 years ]
    Time from start of treatment to complete response or partial response
  • Duration of Response (DOR) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 1 year ]
    Proportion of participants alive at 1 year from the start of treatment to death from any cause
  • 2 Year Overall Survival (2YOS) [ Time Frame: 2 years ]
    Proportion of participants alive at 2 years from the start of treatment to death from any cause
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First in Human Study of UCT-01-097 in Participants With Advanced Solid Tumors
Official Title  ICMJE A Phase 1, First in Human, Dose-Escalation Study of UCT-01-097 in Participants With Advanced Solid Tumors
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumor
Intervention  ICMJE
  • Drug: UCT-01-097
    Orally available kinase inhibitor
  • Drug: Gemcitabine
    Gemcitabine injection for intravenous use.
    Other Name: Gemzar
  • Drug: Paclitaxel
    Paclitaxel protein-bound particles for injectable suspension (albumin-bound).
    Other Name: Abraxane
Study Arms  ICMJE
  • Experimental: Dose Finding as Monotherapy - Part 1
    Intervention: Drug: UCT-01-097
  • Experimental: Expansion as Monotherapy - Part 2
    Intervention: Drug: UCT-01-097
  • Experimental: Dose Finding in Combination - Part 3
    Interventions:
    • Drug: UCT-01-097
    • Drug: Gemcitabine
    • Drug: Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 16, 2021)
106
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2024
Estimated Primary Completion Date September 23, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stephen Letrent, PharmD, PhD 858-342-6652 stephen.letrent@1200pharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04761601
Other Study ID Numbers  ICMJE UCT01097-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party 1200 Pharma, LLC
Study Sponsor  ICMJE 1200 Pharma, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Stephen Letrent, PharmD, PhD 1200 Pharma, LLC
PRS Account 1200 Pharma, LLC
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP