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
Key facts
- Who runs it
- Omega Therapeutics
- Where
- Chicago, Duarte, Gainesville, New Orleans, Oklahoma City, and Seattle, United StatesSee the 6 sitesAlso in 4 other countries, 9 sites
- Trial code
- Status
- Terminated
- Phase
- Phase 1/2
- People taking part
- 24 people enrolled
- Started
- 19 Aug 2022
- Ended
- 21 Nov 2024
- Type of study
- Interventional, 4 groups
- Treatments tested
- OTX-2002
- Tyrosine kinase inhibitor One
- Tyrosine kinase inhibitor Two
- Checkpoint Inhibitor, Immune
- Record updated
- 3 February 2025
- Why it stopped
- Sponsor decision to terminate after monotherapy dose escalation.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Other criteria
- Key inclusion
- Participants with metastatic, advanced (non-resectable), or recurrent solid tumor who progressed on, relapsed after, are refractory to, or intolerant of standard of care (only applicable to Part 1 escalation)
- Participants with BCLC Stage B (intermediate stage) or C (advanced stage), Child-Pugh A hepatocellular carcinoma who is not amenable to locoregional therapy, refractory to locoregional therapy or not amenable to curative treatment approach
- Adult participants age ≥ 18 years at the time of signing informed consent
- Participant must have progressed on, have relapsed after, be refractory to, or be intolerant of at least 1 prior systemic therapy, and without available subsequent standard of care
- Participants with chronic hepatitis B must have received antiviral therapy for hepatitis B virus (HBV) for at least 12 weeks and HBV viral load must be < 500 IU/mL prior to first dose of study drug
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Key exclusion
- Mixed histology cholangiocarcinoma and HCC, or fibrolamellar variant HCC
- Hepatocellular carcinoma with ≥ 50% liver occupation
- Clear invasion into the bile duct
- Portal vein invasion with Vp4
- Active/untreated CNS metastases or carcinomatous meningitis
- History of ascites requiring paracentesis within the past 3 months
- Esophageal or gastric variceal bleeding in the past 3 months
- History of hepatic encephalopathy in the past 3 months
Where in United States
Also in 4 other countries, 9 sites
- University of ChicagoChicago, United StatesNo longer taking part
- City of HopeDuarte, United StatesNo longer taking part
- University of Florida Health Cancer CenterGainesville, United StatesNo longer taking part
- Ochsner Clinic FoundationNew Orleans, United StatesNo longer taking part
- Stephenson Cancer Center at Oklahoma UniversityOklahoma City, United StatesNo longer taking part
- Fred Hutch / University of WashingtonSeattle, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
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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.
The 4 groups in the trial
- OTX-2002Treatment being tested
Monotherapy: OTX-2002 (Cycle length = 4 weeks) OTX-2002 will be administered as an IV infusion over 80-120 minutes every 2 weeks
- OTX-2002 + Tyrosine Kinase Inhibitor OneTreatment being tested
OTX-2002 + Tyrosine Kinase Inhibitor One: (Cycle length = 4 weeks) OTX-2002 will be administered as an IV infusion over 80-120 minutes every 2 weeks. Tyrosine Kinase Inhibitor One will be standard per the respective fixed local approved dose
Treatment: OTX-2002 and Tyrosine kinase inhibitor One
- OTX-2002 + Tyrosine Kinase Inhibitor TwoTreatment being tested
OTX-2002 + Tyrosine Kinase Inhibitor Two : (Cycle length = 4 weeks) OTX-2002 will be administered as an IV infusion over 80-120 minutes every 2 weeks. Tyrosine Kinase Inhibitor Two will be standard per the respective fixed local approved dose
Treatment: OTX-2002 and Tyrosine kinase inhibitor Two
- OTX-2002 + Checkpoint InhibitorTreatment being tested
OTX-2002 + Immune Checkpoint Blockade: (Cycle length = 6 weeks) OTX-2002 will be administered as an IV infusion over 80-120 minutes every 2 weeks. Checkpoint Inhibitor will be standard per the respective fixed local approved dose
Treatment: OTX-2002 and Checkpoint Inhibitor, Immune
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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 and Other Solid Tumor Types Known for Association with the MYC Oncogene
- Record updated
- 3 February 2025