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 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 HCCHepatocellular 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.