Phase 1 Study of ERX-315 Given by IV Twice Weekly in Adults With Advanced Solid Tumors That Have Not Responded to Standard Treatments

What this Trial Is About

This research aims to assess the safety, tolerability, and pharmacokinetics of ERX-315 in adults with advanced solid tumors, including breast, ovarian, pancreatic, endometrial, and liver cancers, who have not responded to approved systemic treatments. This is an open-label Phase 1 trial focused on patients with measurable, advanced, unresectable, or metastatic disease. The study evaluates escalating doses of ERX-315 to understand how the drug behaves in the body and its preliminary safety profile. Participants will receive ERX-315 through intravenous injections twice a week in 21-day treatment cycles. The study includes a dose escalation phase to identify the recommended dose for future trials. ERX-315 dosing starts at 0.4 mgkg and is increased over time to evaluate safety and side effects. This trial does not include placebo or comparator groups and aims to monitor dose limiting toxicities and adverse events. During the study, participants will undergo regular assessments of safety, including monitoring for side effects, laboratory tests, and evaluation of organ function. Pharmacokinetic measurements such as drug concentration and half-life will be collected to understand drug behavior. Researchers will also assess tumor response and progression. The study period for primary safety outcomes is 21 to 84 days, with ongoing monitoring for up to 84 days. Participants are expected to have a life expectancy over 3 months and will be followed for adverse events and clinical responses during the trial.

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