First in Human Study of UCT-03-008 in Participants With Advanced Solid Tumors

NCT05103046 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: UCT03008-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 5

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Incidence and severity of adverse events and serious adverse events

  Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0

  up to 2 years

• Maximum Tolerated Dose (MTD)

  Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants

  28 Days

• Recommended Phase 2 Dose (RP2D)

  Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

  up to 2 years

Secondary Outcomes (17)

• Maximum Plasma UCT-03-008 Concentration following single dose (Cmax)

  Cycle 0(each cycle is 28 days)

• Maximum Plasma UCT-03-008 Concentration at steady state (Cmax,ss)

  Cycle 1 (each cycle is 28 days)

• Minimum Plasma UCT-03-008 Concentration following single dose (Cmin)

  Cycle 0 (each cycle is 28 days)

• Minimum Plasma UCT-03-008 Concentration at steady state (Cmin,ss)

  Cycle 1 (each cycle is 28 days)

• Time of Maximum Plasma UCT-03-008 Concentration following single dose (Tmax)

  Cycle 0 (each cycle is 28 days)

Study Arms (2)

Dose Finding as Monotherapy - Part 1

EXPERIMENTAL

UCT-03-008 Dose Finding

Drug: UCT-03-008

Expansion as Monotherapy - Part 2

EXPERIMENTAL

UCT-03-008 RP2D Expansion

Drug: UCT-03-008

Interventions

UCT-03-008 DRUG

Orally available kinase inhibitor

Dose Finding as Monotherapy - Part 1; Expansion as Monotherapy - Part 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced solid tumor
• Measurable disease, per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Adequate organ function

You may not qualify if:

• 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

Sponsors & Collaborators

• 1200 Pharma, LLC: lead
• Translational Research in Oncology: collaborator

Study Sites (5)

UCLA - JCCC Clinical Research Unit

Los Angeles, California, 90095, United States

RECRUITING

Torrance Memorial

Torrance, California, 90505, United States

TERMINATED

Winship Institute of Emory University

Atlanta, Georgia, 30322, United States

TERMINATED

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

RECRUITING

START (South Texas Accelerated Research Therapeutics)

San Antonio, Texas, 78229, United States

TERMINATED

Study Officials

• Alex Garcia

  TRIO-US

  STUDY DIRECTOR

Central Study Contacts

Alex Garcia

CONTACT

213-5197493; AGarcia@trio-us.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: December 23, 2021
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)