Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors

A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation, Confirmation and Expansion Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of TH9619 in Subjects With Advanced Solid Tumors

This is a first in human, multi-center, open-label, dosage escalation study to determine the recommended dose range of TH9619 in subjects with advanced cancer.

Inclusion Criteria:

• Must have given written informed consent
• Histopathologically confirmed advanced cancer (colorectal cancer, head and neck squamous cell cancer, non-small cell lung cancer and gastric cancer (including gastroesophageal junction cancer))
• Prior treatment with at least one line of cytotoxic systemic therapy for metastatic/unresectable cancer
• Adult patients (≥18 years of age)
• Must be willing to comply with study procedures

Exclusion Criteria:

• History or presence of any clinically significant disorders as judged by the Investigator.