ERX-315-101
ERX-315-101: A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
Trial summary:
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.
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.
Receptor status / problem studied:
Inclusion criteria
1) Patients must be at least 18 years of age at the time of signing the informed consent.
2) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
3) 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.
4) Patients must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
5) Adequate baseline organ function and hematologic function.
6) Life expectancy >3 months.
Exclusion criteria
1) Systemic anti cancer therapy within 4 weeks of first dose of study drug.
2) Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.
3) Uncontrolled intercurrent illnesses.
4) Known history of LIPA deficiency, such as Wolman disease or Cholesterol ester storage disease.
Trial Title
ERX-315-101
Diagnosis
Advanced solid tumours
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
I