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A Phase 1/2 Study to Evaluate OTX-2002 in Patients with Hepatocellular Carcinoma and Other Solid Tumor Types Known for Association with the MYC Oncogene

NCT05497453 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-02-03

No results posted yet for this study

Summary

This is a Phase 1/2 open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of OTX-2002 as a single agent and in combination with standard of care in patients with hepatocellular carcinoma (HCC) and other solid tumor types known for association with the MYC oncogene.

The study consists of Part 1 (OTX-2002 monotherapy) and Part 2 (OTX-2002 combined with standard of care in hepatocellular carcinoma). Part 1 consists of escalation and expansion, and Part 2 consists of safety run-in and expansion. The objective of Part 1 escalation and Part 2 safety run-in will be safety and tolerability, while anti-tumor activity will be evaluated as the primary endpoint in Part 1 and Part 2 expansion.

Conditions

Interventions

DRUG

OTX-2002

OTX-2002 is a lipid nanoparticle (LNP) that contains a biscistronic mRNA that codes for 2 independent epigenomic controllers.

DRUG

Tyrosine kinase inhibitor One

Tyrosine Kinase Inhibitor

DRUG

Tyrosine kinase inhibitor Two

tyrosine kinase inhibitor

DRUG

Checkpoint Inhibitor, Immune

monoclonal antibody that binds to PD-1 or PD-L1

Sponsors & Collaborators

  • Omega Therapeutics

    lead INDUSTRY

Principal Investigators

  • Yan Moore, MD · Omega Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-19
Primary Completion
2024-11-21
Completion
2024-11-21
FDA Drug
Yes

Countries

  • United States
  • Hong Kong
  • Singapore
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05497453 on ClinicalTrials.gov