Clinical trialPhase 1Recruiting
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
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Recruiting
- Study type
- Interventional
- Start
- 14 October 2024
- Expected end
- 30 June 2027
- Enrollment
- 36 participants
- Sites
- 5
- Primary outcomes
- Incidence of Dose Limiting Toxicities of ERX-315; Incidence of Adverse Events as a measure of safety and tolerability of ERX-315; Incidence of laboratory abnormalities as a measure of safety and tolerability of ERX-315; Determination of the recommended phase 2 dose
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 29 May 2026
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.