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

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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

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: UCT-01-097 Drug: Gemcitabine Drug: Paclitaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 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-01-097 in Participants With Advanced Solid Tumors
Actual Study Start Date : March 3, 2021
Estimated Primary Completion Date : September 23, 2023
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose Finding as Monotherapy - Part 1 Drug: UCT-01-097
Orally available kinase inhibitor

Experimental: Expansion as Monotherapy - Part 2 Drug: UCT-01-097
Orally available kinase inhibitor

Experimental: Dose Finding in Combination - Part 3 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




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-01-097 Concentration (Cmax) [ Time Frame: Day 1 ]
    PK assessment for UCT-01-097

  2. Maximum Plasma UCT-01-097 Concentration at steady state (Cmax,ss) [ Time Frame: Day 15 ]
    PK assessment for UCT-01-097

  3. UCT-01-097 Trough Plasma Concentration (Cmin) [ Time Frame: Day 1 ]
    PK assessment for UCT-01-097

  4. UCT-01-097 Trough Plasma Concentration at Steady State (Cmin,ss) [ Time Frame: Day 15 ]
    PK assessment for UCT-01-097

  5. Time of Maximum Plasma UCT-01-097 Concentration (Tmax) [ Time Frame: Cycle 1 (each cycle is 28 days) ]
    PK assessment for UCT-01-097

  6. 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

  7. Apparent Clearance (CL/F) of UCT-01-097 [ Time Frame: Cycle 1 (each cycle is 28 days) ]
    PK assessment for UCT-01-097

  8. 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

  9. Accumulation Ratio (Rac) of UCT-01-097 [ Time Frame: Cycle 1 (each cycle is 28 days) ]
    PK assessment for UCT-01-097

  10. Terminal Half-life (t1/2) of UCT-01-097 [ Time Frame: Cycle 1 (each cycle is 28 days) ]
    PK assessment for UCT-01-097

  11. 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

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

  13. 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

  14. 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

  15. 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

  16. 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-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

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): NCT04761601


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: Zev Wainberg, MD    310-586-2094      
Sponsors and Collaborators
1200 Pharma, LLC
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: NCT04761601    
Other Study ID Numbers: UCT01097-001
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
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
Gemcitabine
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs