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NCT Number: NCT06533332

A Phase 1 Trial 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.

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Key information

Conditions

Advanced Solid Tumor Adnexal Diseases Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Liver Diseases Liver Neoplasms Metastatic Breast Cancer Metastatic Endometrial Cancer Metastatic Liver Cancer Metastatic Ovarian Cancer Metastatic Pancreatic Cancer Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Pancreatic Diseases Pancreatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Macquarie University Health, Ryde, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ERX-315

Drug

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

Primary outcomes

  1. Incidence of Dose Limiting Toxicities of ERX-315

    Time frame: 21 days

    First cycle dose limiting toxicities characterized by type, frequency, severity, timing, seriousness, and relationship to study drug

  2. Incidence of Adverse Events as a measure of safety and tolerability of ERX-315

    Time frame: 84 days

    Adverse events as characterized by type, frequency, severity (grade), timing, seriousness, and relationship to study drug.

  3. Incidence of laboratory abnormalities as a measure of safety and tolerability of ERX-315

    Time frame: 84 days

    Laboratory abnormalities as characterized by type, frequency, severity, and timing.

  4. Determination of the recommended phase 2 dose

    Time frame: 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 outcomes

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

    Time frame: 21 days

    AUC will be determined by non-compartmental analysis and assessed after single and multiple doses of drug

  2. Assessment of pharmacokinetic outcome measure of Peak Plasma concentration (Cmax)

    Time frame: 21 days

    Cmax will be determined by non-compartmental analysis and assessed after single and multiple doses of drug

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

    Time frame: 21 days

    t1/2 will be assessed after single and multiple doses of drug

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

    Time frame: 84 days

    ORR will be assessed by RECIST v1.1

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

    Time frame: 84 days

    BOCR will be assessed by RECIST v1.1

  6. Antitumor activity of ERX-315 based on Duration of response (DOR)

    Time frame: 84 days

    DOR will be assessed by RECIST v1.1 and time frame of response

  7. Antitumor activity of ERX-315 based on Progression-free survival (PFS)

    Time frame: 84 days

    PFS will be assessed by RECIST v1.1 and time frame of response

Other outcomes

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

    Time frame: 84 days

    Effect of ERX-315 on the changes from baseline in patient reported symptoms using the PRO-CTCAE Questionnaire

  2. Serum LIPA lipase activity as pharmacodynamic markers of ERX-315 activity

    Time frame: 84 days

    The effect of ERX-315 on serum LIPA lipase activity may be evaluated

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

    Time frame: 84 days

    The effect of ERX-315 on circulating tumor DNA levels may be evaluated

Study contacts

Contact information is provided by the study sponsor or research team.

Research Director

CONTACT

[email protected]

01 469 600 6603

Sponsors and collaborators

Lead sponsor

EtiraRx Australia Pty Ltd

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 1, 2024
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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