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

NCT06533332 | Recruiting Phase 1

• 1 other identifier: ERX-315-101
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

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.

Conditions

Advanced Solid Tumor; Metastatic Breast Cancer; Metastatic Ovarian Cancer; Metastatic Endometrial Cancer; Metastatic Liver Cancer; Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Assessment of pharmacokinetic outcome measure of Area under the plasma concentration versus time curve (AUC).

  21 days

• Assessment of pharmacokinetic outcome measure of Peak Plasma concentration (Cmax)

  21 days

• Assessment of pharmacokinetic outcome measure of drug half-life (t1/2)

  21 days

• Antitumor activity of ERX-315 based on Objective response rate (ORR)

  84 days

• Antitumor activity of ERX-315 based on Best Overall Clinical Response (BOCR)

  84 days

Other Outcomes (3)

• Impact on patient reported symptoms using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire

  84 days

• Serum LIPA lipase activity as pharmacodynamic markers of ERX-315 activity

  84 days

• Circulating tumor DNA levels as pharmacodynamic markers of ERX-315 activity

  84 days

Study Arms (1)

ERX-315

EXPERIMENTAL

Active investigational therapy

Drug: ERX-315

Interventions

ERX-315 DRUG

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

ERX-315

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• EtiraRx Australia Pty Ltd: lead

Study Sites (4)

Macquarie University Health

Ryde, New South Wales, 2109, Australia

RECRUITING

The Kinghorn Cancer Center

Sydney, New South Wales, 2010, Australia

RECRUITING

Cancer Research SA

Adelaide, South Australia, 5000, Australia

RECRUITING

Icon Cancer Centre Adelaide

Adelaide, South Australia, 5037, Australia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Liver Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Pancreatic Diseases

Study Officials

• Rasha Cosman, MBBS

  The Kinghorn Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Director

CONTACT

01 469 600 6603; contact@etira.life

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: August 1, 2024
• Study Start: October 14, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)