A First in Human Study of PLT012 in Participants With Solid Tumor Cancers

This study is a phase 1, open label, dose escalation and dose expansion study using an initial single participant cohort followed by a BOIN design to evaluate multiple ascending doses of PLT012.

Inclusion criteria

• Aged at least 18 years and provided written informed consent
• Histologically or cytologically confirmed advanced solid tumors (except primary CNS malignancies)
• Has at least one measurable lesion per RECIST v1.1
• ECOG PS of 0 to 1
• Life expectancy of ≥ 12 weeks
• Child-Pugh score of Class A (for hepatocellular carcinoma only)
• Adequate organ function as defined by protocol-specified laboratory values
• Not pregnant or breastfeeding

Exclusion criteria

• Insufficient washout period from prior therapies as defined in the study protocol
• Ongoing Grade 2 or higher toxicities from prior treatments (with some exceptions)
• Concurrent or recent (within 2 years) malignancy other than the disease under study (with some exceptions)
• Uncontrolled HIV, uncontrolled hepatitis B, or uncontrolled acute hepatitis C infections
• Unstable/uncontrolled or untreated central nervous system (CNS) metastasis
• Active or recent (within 3 years) autoimmune disease requiring medical treatment
• Recipient of any organ transplant including allogeneic stem-cell transplant
• Clinically significant and active cardiovascular disease
• Known active alcohol or drug abuse
• Psychiatric disorders that would prohibit the understanding of the Informed Consent Form
• Ascites requiring therapeutic paracentesis or hepatic encephalopathy requiring medical interventions within the past 6 months (if hepatocellular carcinoma)