Clinical trial NCT06533332: A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Metastatic Breast Cancer
Metastatic Ovarian Cancer
Metastatic Endometrial Cancer
Metastatic Liver Cancer
Metastatic Pancreatic Cancer
Lead sponsor: EtiraRx Australia Pty Ltd
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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 outcomes:
measure: Incidence of Dose Limiting Toxicities of ERX-315
timeFrame: 21 days
measure: Incidence of Adverse Events as a measure of safety and tolerability of ERX-315
timeFrame: 84 days
measure: Incidence of laboratory abnormalities as a measure of safety and tolerability of ERX-315
timeFrame: 84 days
measure: Determination of the recommended phase 2 dose
timeFrame: 84 days
Secondary outcomes:
measure: Assessment of pharmacokinetic outcome measure of Area under the plasma concentration versus time curve (AUC).
timeFrame: 21 days
measure: Assessment of pharmacokinetic outcome measure of Peak Plasma concentration (Cmax)
timeFrame: 21 days
measure: Assessment of pharmacokinetic outcome measure of drug half-life (t1/2)
timeFrame: 21 days
measure: Antitumor activity of ERX-315 based on Objective response rate (ORR)
timeFrame: 84 days
measure: Antitumor activity of ERX-315 based on Best Overall Clinical Response (BOCR)
timeFrame: 84 days
measure: Antitumor activity of ERX-315 based on Duration of response (DOR)
timeFrame: 84 days
measure: Antitumor activity of ERX-315 based on Progression-free survival (PFS)
timeFrame: 84 days
Other outcomes:
measure: Impact on patient reported symptoms using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire
timeFrame: 84 days
measure: Serum LIPA lipase activity as pharmacodynamic markers of ERX-315 activity
timeFrame: 84 days
measure: Circulating tumor DNA levels as pharmacodynamic markers of ERX-315 activity
timeFrame: 84 days
Locations:
city: Sydney
country: Australia
facility: The Kinghorn Cancer Center
state: New South Wales
city: Sydney
country: Australia
facility: MQ Health Medical Oncology and Clinical Trials/Macquarie University
state: New South Wales
city: Adelaide
country: Australia
facility: Cancer Research SA
state: South Australia
Study officials:
affiliation: The Kinghorn Cancer Centre
name: Rasha Cosman, MBBS
role: PRINCIPAL_INVESTIGATOR
References: