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 (MYCHELANGELO I)
Hepatocellular Carcinoma, Solid Tumor, Hepatocellular Carcinoma Non-resectable
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring MYC, C-MYC, MYC Amplification, MYC Overexpression, MRNA, Epigenetics
Eligibility 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.
Sites / Locations
- City of HopeRecruiting
- University of Florida Health Cancer CenterRecruiting
- Ochsner Clinic FoundationRecruiting
- Stephenson Cancer Center at Oklahoma UniversityRecruiting
- Next OncologyRecruiting
- Fred Hutch / University of WashingtonRecruiting
- Prince of Wales HospitalRecruiting
- Queen Mary HospitalRecruiting
- Asan Medical CenterRecruiting
- Seoul National University HospitalRecruiting
- Severance Hospital, Yonsei University Health SystemRecruiting
- National Cancer Center SingaporeRecruiting
- National University HospitalRecruiting
- National Cheng Kung University HospitalRecruiting
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
OTX-2002
OTX-2002 + Tyrosine Kinase Inhibitor One
OTX-2002 + Tyrosine Kinase Inhibitor Two
OTX-2002 + Checkpoint Inhibitor
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 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
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
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