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

EtiraRx Australia Pty Ltd

Status and phase: Enrolling; Phase 1

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

Treatments: Drug: ERX-315

Study type: Interventional

Funder types: Other

Identifiers

NCT06533332

ERX-315-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

ERX-315

Experimental group

Description:

Active investigational therapy

Treatment:

Drug: ERX-315