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

A First-in-Human, Phase 1 Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy Study of Escalating Doses of ERX-315 in Participants With Advanced Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Breast Cancer; Advanced Solid Tumor; Metastatic Pancreatic Cancer; Metastatic Endometrial Cancer; Metastatic Liver Cancer; Metastatic Ovarian Cancer
• Intervention / Treatment: Drug: ERX-315

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Research Director; Phone Number: 01 469 600 6603; Email: contact@etira.life

Study Locations

• Australia
  • New South Wales
    • Ryde, New South Wales, Australia, 2109
      • Recruiting
      • Macquarie University Health
      • Contact: Phone Number: +61 (2) 9812 3000; Email: reception@muh.org.au
      • Principal Investigator: Danusha Sabanathan, FRACP PhD
    • Sydney, New South Wales, Australia, 2010
      • Recruiting
      • The Kinghorn Cancer Center
    • Westmead, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital
      • Contact: Jeremy Mo, MD; Phone Number: (02) 8890 6666
      • Principal Investigator: Jeremy Mo, MD
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Cancer Research SA
      • Contact: Kelly Mead; Phone Number: 08 8359 2565; Email: admin@crsa.au
      • Principal Investigator: Rohit Joshi, MBBS, FRACP
    • Adelaide, South Australia, Australia, 5037
      • Recruiting
      • Icon Cancer Centre Adelaide
      • Contact: Phone Number: 08 8474 0220; Email: admin.adelaide@icon.team
      • Principal Investigator: Anna Mislang, MBBS, FRACP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ERX-315; Active investigational therapy	Drug: ERX-315; Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	21 days
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.	84 days
Incidence of laboratory abnormalities as a measure of safety and tolerability of ERX-315	Laboratory abnormalities as characterized by type, frequency, severity, and timing.	84 days
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	84 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	21 days
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	21 days
Assessment of pharmacokinetic outcome measure of drug half-life (t1/2)	t1/2 will be assessed after single and multiple doses of drug	21 days
Antitumor activity of ERX-315 based on Objective response rate (ORR)	ORR will be assessed by RECIST v1.1	84 days
Antitumor activity of ERX-315 based on Best Overall Clinical Response (BOCR)	BOCR will be assessed by RECIST v1.1	84 days
Antitumor activity of ERX-315 based on Duration of response (DOR)	DOR will be assessed by RECIST v1.1 and time frame of response	84 days
Antitumor activity of ERX-315 based on Progression-free survival (PFS)	PFS will be assessed by RECIST v1.1 and time frame of response	84 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	84 days
Serum LIPA lipase activity as pharmacodynamic markers of ERX-315 activity	The effect of ERX-315 on serum LIPA lipase activity may be evaluated	84 days
Circulating tumor DNA levels as pharmacodynamic markers of ERX-315 activity	The effect of ERX-315 on circulating tumor DNA levels may be evaluated	84 days

Collaborators and Investigators

• Sponsor: EtiraRx Australia Pty Ltd
• Investigators: Principal Investigator: Rasha Cosman, MBBS, The Kinghorn Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: July 22, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Digestive System Neoplasms; Digestive System Diseases; Uterine Diseases; Genital Diseases, Female; Endocrine Gland Neoplasms; Pancreatic Diseases; Liver Diseases; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Skin Diseases; Breast Diseases; Uterine Neoplasms; Skin and Connective Tissue Diseases; Ovarian Neoplasms; Breast Neoplasms; Pancreatic Neoplasms; Liver Neoplasms; Endometrial Neoplasms
• Other Study ID Numbers: ERX-315-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes