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.
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.
Single group
ERX-315
DrugDrug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg.
Incidence of Dose Limiting Toxicities of ERX-315
First cycle dose limiting toxicities characterized by type, frequency, severity, timing, seriousness, and relationship to study drug
Incidence of Adverse Events as a measure of safety and tolerability of ERX-315
Adverse events as characterized by type, frequency, severity (grade), timing, seriousness, and relationship to study drug.
Incidence of laboratory abnormalities as a measure of safety and tolerability of ERX-315
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Determination of the recommended phase 2 dose
To determine the recommended phase 2 dose(s) for additional evaluation of ERX-315 in clinical trials for participants with advanced solid tumors
Assessment of pharmacokinetic outcome measure of Area under the plasma concentration versus time curve (AUC).
AUC will be determined by non-compartmental analysis and assessed after single and multiple doses of drug
Assessment of pharmacokinetic outcome measure of Peak Plasma concentration (Cmax)
Cmax will be determined by non-compartmental analysis and assessed after single and multiple doses of drug
Assessment of pharmacokinetic outcome measure of drug half-life (t1/2)
t1/2 will be assessed after single and multiple doses of drug
Antitumor activity of ERX-315 based on Objective response rate (ORR)
ORR will be assessed by RECIST v1.1
Impact on patient reported symptoms using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire
Effect of ERX-315 on the changes from baseline in patient reported symptoms using the PRO-CTCAE Questionnaire
Serum LIPA lipase activity as pharmacodynamic markers of ERX-315 activity
The effect of ERX-315 on serum LIPA lipase activity may be evaluated
Circulating tumor DNA levels as pharmacodynamic markers of ERX-315 activity
The effect of ERX-315 on circulating tumor DNA levels may be evaluated
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