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First in Human Study of UCT-03-008 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: NCT05103046
Recruitment Status : Recruiting
First Posted : November 2, 2021
Last Update Posted : July 27, 2022
Sponsor:
Collaborator:
Translational Research in Oncology
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: UCT-03-008 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First in Human, Dose-Escalation Study of UCT-03-008 in Participants With Advanced Solid Tumors
Actual Study Start Date : December 23, 2021
Estimated Primary Completion Date : December 15, 2024
Estimated Study Completion Date : December 15, 2025

Arm Intervention/treatment
Experimental: Dose Finding as Monotherapy - Part 1
UCT-03-008 Dose Finding
Drug: UCT-03-008
Orally available kinase inhibitor

Experimental: Expansion as Monotherapy - Part 2
UCT-03-008 RP2D Expansion
Drug: UCT-03-008
Orally available kinase inhibitor




Primary Outcome Measures :
  1. 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

  2. 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

  3. Recommended Phase 2 Dose (RP2D) [ Time Frame: up to 2 years ]
    Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data


Secondary Outcome Measures :
  1. Maximum Plasma UCT-03-008 Concentration following single dose (Cmax) [ Time Frame: Cycle 0(each cycle is 28 days) ]
    PK assessment for UCT-03-008

  2. Maximum Plasma UCT-03-008 Concentration at steady state (Cmax,ss) [ Time Frame: Cycle 1 (each cycle is 28 days) ]
    PK assessment for UCT-03-008

  3. Minimum Plasma UCT-03-008 Concentration following single dose (Cmin) [ Time Frame: Cycle 0 (each cycle is 28 days) ]
    PK assessment for UCT-003-008

  4. Minimum Plasma UCT-03-008 Concentration at steady state (Cmin,ss) [ Time Frame: Cycle 1 (each cycle is 28 days) ]
    PK assessment for UCT-003-008

  5. Time of Maximum Plasma UCT-03-008 Concentration following single dose (Tmax) [ Time Frame: Cycle 0 (each cycle is 28 days) ]
    PK assessment for UCT-03-008

  6. Time of Maximum Plasma UCT-03-008 Concentration at steady state (Tmax,ss) [ Time Frame: Cycle 0 (each cycle is 28 days) ]
    PK assessment for UCT-03-008

  7. Area Under the Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) of UCT-03-008 [ Time Frame: Cycle 0 (each cycle is 28 days) ]
    PK assessment for UCT-03-008

  8. Area Under the Plasma Concentration-Time Curve from the time of dosing to the last measurable concentration (AUClast) of UCT-03-008 [ Time Frame: Cycle 0 (each cycle is 28 days) ]
    PK assessment for UCT-03-008

  9. Apparent Clearance (CL/F) of UCT-03-008 [ Time Frame: Cycle 0 (each cycle is 28 days) ]
    PK assessment for UCT-03-008

  10. Apparent Volume of Distribution (Vz/F) of UCT-03-008 [ Time Frame: Cycle 0 (each cycle is 28 days) ]
    PK assessment for UCT-03-008

  11. Terminal Half-life (t1/2) of plasma UCT-03-008 [ Time Frame: Cycle 1 (each cycle is 28 days) ]
    PK assessment for UCT-03-008

  12. Objective Response Rate (ORR) [ Time Frame: up to 2 years ]
    Percentage of participants with best response of complete response (CR) or partial response (PR) according to RECIST 1.1

  13. Time to Response (TTR) [ Time Frame: up to 2 years ]
    Time from start of treatment to complete response or partial response

  14. 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

  15. 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

  16. 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

  17. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05103046


Contacts
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Contact: Stephen Letrent, PharmD, PhD 858-342-6652 stephen.letrent@1200pharma.com

Locations
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United States, California
UCLA - JCCC Clinical Research Unit Recruiting
Los Angeles, California, United States, 90095
Contact: Jonathan Goldman, MD    310-923-8712      
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
Contact: Minal Barve, MD    972-566-3000      
START (South Texas Accelerated Research Therapeutics) Recruiting
San Antonio, Texas, United States, 78229
Contact: Amita Patnaik, MD    210-593-5250      
Sponsors and Collaborators
1200 Pharma, LLC
Translational Research in Oncology
Investigators
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Study Director: Stephen Letrent, PharmD, PhD 1200 Pharma, LLC
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Responsible Party: 1200 Pharma, LLC
ClinicalTrials.gov Identifier: NCT05103046    
Other Study ID Numbers: UCT03008-001
First Posted: November 2, 2021    Key Record Dates
Last Update Posted: July 27, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms