Overview
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.
Description
The goal of this open-label, dose escalation and cohort expansion Phase 1 clinical trial is to determine the safety, tolerability and pharmacokinetics of ERX-315 in patients with advanced solid tumors, who have progressed on prior approved systemic therapies. Participants will receive ERX-315 as an intravenous (IV) injection twice a week, over 21-day cycles.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- Systemic anti cancer therapy within 4 weeks of first dose of study drug
- Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.
- Uncontrolled intercurrent illnesses
- Known history of LIPA deficiency, such as Wolman disease or Cholesterol ester storage disease.