A First-in-Human, Phase 1 Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy Study of Escalating Doses of ERX-315 in Participants With Advanced Solid Tumors
This is a Phase 1 study to assess the safety of ERX-315 in patients with advanced solid tumors that have failed approved systemic therapies.
• Patients must be at least 18 years of age at the time of signing the informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Patients must have histologically or cytologically confirmed solid tumor, primarily including but not limited to breast, ovarian, pancreatic, endometrial and hepatocellular carcinoma, that is advanced unresectable and/or metastatic disease for whom standard therapies do not exist or are no longer effective
• Patients must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Adequate baseline organ function and hematologic function
• Life expectancy \>3 months