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History of Changes for Study: NCT05103046
First in Human Study of UCT-03-008 in Participants With Advanced Solid Tumors
Latest version (submitted July 25, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 21, 2021 None (earliest Version on record)
2 January 27, 2022 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 July 25, 2022 Study Status and Contacts/Locations
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Study NCT05103046
Submitted Date:  October 21, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: UCT03008-001
Brief Title: First in Human Study of UCT-03-008 in Participants With Advanced Solid Tumors
Official Title: A Phase 1, First in Human, Dose-Escalation Study of UCT-03-008 in Participants With Advanced Solid Tumors
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2021
Overall Status: Not yet recruiting
Study Start: December 15, 2021
Primary Completion: December 15, 2024 [Anticipated]
Study Completion: December 15, 2025 [Anticipated]
First Submitted: October 21, 2021
First Submitted that
Met QC Criteria:
October 21, 2021
First Posted: November 2, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
October 21, 2021
Last Update Posted: November 2, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: 1200 Pharma, LLC
Responsible Party: Sponsor
Collaborators: Translational Research in Oncology
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Advanced Solid Tumor
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 68 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Stephen Letrent, PharmD, PhD
Telephone: 858-342-6652
Email: stephen.letrent@1200pharma.com
Study Officials: Stephen Letrent, PharmD, PhD
Study Director
1200 Pharma, LLC
Locations: United States, California
UCLA - JCCC Clinical Research Unit
Los Angeles, California, United States, 90095
Contact:Contact: Jonathan Goldman, MD 310-923-8712
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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