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Recruiting NCT06533332

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

Phase I Interventional Advanced Solid Tumor Metastatic Breast Cancer Metastatic Ovarian Cancer Metastatic Endometrial Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ERX-315.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor, Metastatic Breast Cancer, Metastatic Ovarian Cancer, Metastatic Endometrial Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug ERX-315
    Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg.

Primary outcome measures

  • Incidence of Dose Limiting Toxicities of ERX-315 [Time frame: 21 days]
  • Incidence of Adverse Events as a measure of safety and tolerability of ERX-315 [Time frame: 84 days]
  • Incidence of laboratory abnormalities as a measure of safety and tolerability of ERX-315 [Time frame: 84 days]
  • Determination of the recommended phase 2 dose [Time frame: 84 days]
Secondary outcome measures (7)
  • Assessment of pharmacokinetic outcome measure of Area under the plasma concentration versus time curve (AUC). [Time frame: 21 days]
  • Assessment of pharmacokinetic outcome measure of Peak Plasma concentration (Cmax) [Time frame: 21 days]
  • Assessment of pharmacokinetic outcome measure of drug half-life (t1/2) [Time frame: 21 days]
  • Antitumor activity of ERX-315 based on Objective response rate (ORR) [Time frame: 84 days]
  • Antitumor activity of ERX-315 based on Best Overall Clinical Response (BOCR) [Time frame: 84 days]
  • Antitumor activity of ERX-315 based on Duration of response (DOR) [Time frame: 84 days]
  • Antitumor activity of ERX-315 based on Progression-free survival (PFS) [Time frame: 84 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 5 centers
  • Macquarie University Health — Ryde
  • The Kinghorn Cancer Center — Sydney
  • Westmead Hospital — Westmead
  • Cancer Research SA — Adelaide
  • Icon Cancer Centre Adelaide — Adelaide

Identifiers

NCT: NCT06533332 · ERX-315-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗