Advanced Solid TumorMetastatic Breast CancerMetastatic Ovarian CancerMetastatic Endometrial CancerMetastatic Liver CancerMetastatic Pancreatic Cancer
Investigational drug(s) / intervention(s)
ERX-315
ERX-315: Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of Dose Limiting Toxicities of ERX-315 — 21 days First cycle dose limiting toxicities characterized by type, frequency, severity, timing, seriousness, and relationship to study drug
Incidence of Adverse Events as a measure of safety and tolerability of ERX-315 — 84 days Adverse events as characterized by type, frequency, severity (grade), timing, seriousness, and relationship to study drug.
Incidence of laboratory abnormalities as a measure of safety and tolerability of ERX-315 — 84 days Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Determination of the recommended phase 2 dose — 84 days To determine the recommended phase 2 dose(s) for additional evaluation of ERX-315 in clinical trials for participants with advanced solid tumors
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.