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

Description

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

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Study Overview

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Study Details

Study overview

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-03-008 in patients with advanced solid tumors.

A Phase 1, First in Human, Dose-Escalation Study of UCT-03-008 in Participants With Advanced Solid Tumors

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

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Los Angeles

UCLA - JCCC Clinical Research Unit, Los Angeles, California, United States, 90095

Torrance

Torrance Memorial, Torrance, California, United States, 90505

Atlanta

Winship Institute of Emory University, Atlanta, Georgia, United States, 30322

Dallas

Mary Crowley Cancer Research, Dallas, Texas, United States, 75230

San Antonio

START (South Texas Accelerated Research Therapeutics), San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

1200 Pharma, LLC,

Alex Garcia, STUDY_DIRECTOR, TRIO-US

Study Record Dates

2025-12-15