A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors

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.

Interventions

• ERX-315 · DRUG

  Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (5)

• Macquarie University Health, Ryde, New South Wales · Recruiting
• The Kinghorn Cancer Center, Sydney, New South Wales · Recruiting
• Westmead Hospital, Westmead, New South Wales · Recruiting
• Cancer Research SA, Adelaide, South Australia · Recruiting
• Icon Cancer Centre Adelaide, Adelaide, South Australia · Recruiting