Trials / Recruiting
RecruitingNCT06533332
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- EtiraRx Australia Pty Ltd · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Advanced Solid Tumor
- Metastatic Breast Cancer
- Metastatic Ovarian Cancer
- Metastatic Endometrial Cancer
- Metastatic Liver Cancer
- Metastatic Pancreatic Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ERX-315 | Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg. |
Timeline
- Start date
- 2024-10-14
- Primary completion
- 2025-12-30
- Completion
- 2026-06-30
- First posted
- 2024-08-01
- Last updated
- 2025-09-18
Locations
4 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT06533332. Inclusion in this directory is not an endorsement.