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

Phase 1

Recruiting

• Conditions: Metastatic Breast Cancer; Metastatic Ovarian Cancer; Metastatic Pancreatic Cancer; Advanced Solid Tumor; Metastatic Liver Cancer; Metastatic Endometrial Cancer
• Interventions: Drug: ERX-315

• Registration Number: NCT06533332
• Lead Sponsor: EtiraRx Australia Pty Ltd

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-29
• Study First Posted: 2024-08-01
• Study Start: 2024-10-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-04-28
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ERX-315	ERX-315	Active investigational therapy

Primary Outcome Measures

Name	Time	Method
Incidence of Dose Limiting Toxicities of ERX-315	21 days	First cycle dose limiting toxicities characterized by type, frequency, severity, timing, seriousness, and relationship to study drug
Incidence of laboratory abnormalities as a measure of safety and tolerability of ERX-315	84 days	Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Incidence of Adverse Events as a measure of safety and tolerability of ERX-315	84 days	Adverse events as characterized by type, frequency, severity (grade), timing, seriousness, and relationship to study drug.
Determination of the recommended phase 2 dose	84 days	To determine the recommended phase 2 dose(s) for additional evaluation of ERX-315 in clinical trials for participants with advanced solid tumors

Secondary Outcome Measures

Name	Time	Method
Assessment of pharmacokinetic outcome measure of Area under the plasma concentration versus time curve (AUC).	21 days	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)	21 days	Cmax will be determined by non-compartmental analysis and assessed after single and multiple doses of drug
Antitumor activity of ERX-315 based on Objective response rate (ORR)	84 days	ORR will be assessed by RECIST v1.1
Antitumor activity of ERX-315 based on Best Overall Clinical Response (BOCR)	84 days	BOCR will be assessed by RECIST v1.1
Antitumor activity of ERX-315 based on Duration of response (DOR)	84 days	DOR will be assessed by RECIST v1.1 and time frame of response
Assessment of pharmacokinetic outcome measure of drug half-life (t1/2)	21 days	t1/2 will be assessed after single and multiple doses of drug
Antitumor activity of ERX-315 based on Progression-free survival (PFS)	84 days	PFS will be assessed by RECIST v1.1 and time frame of response

Trial Locations

Locations (3)

The Kinghorn Cancer Center; 🇦🇺 Sydney, New South Wales, Australia

MQ Health Medical Oncology and Clinical Trials/Macquarie University; 🇦🇺 Sydney, New South Wales, Australia

Cancer Research SA; 🇦🇺 Adelaide, South Australia, Australia