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

Phase 1RecruitingNCT06533332

EtiraRx Australia Pty Ltd15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumor Metastatic Breast Cancer Metastatic Ovarian Cancer Metastatic Endometrial Cancer Metastatic Liver Cancer Metastatic Pancreatic Cancer

Interventions

ERX-315DRUG

Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Macquarie University Health

Ryde, New South Wales, Australia

RECRUITING

The Kinghorn Cancer Center

Sydney, New South Wales, Australia

RECRUITING

Cancer Research SA

Adelaide, South Australia, Australia

RECRUITING

Outcomes

Primary Outcomes

Incidence of Dose Limiting Toxicities of ERX-315

First cycle dose limiting toxicities characterized by type, frequency, severity, timing, seriousness, and relationship to study drug

Time frame: 21 days

Incidence of Adverse Events as a measure of safety and tolerability of ERX-315

Adverse events as characterized by type, frequency, severity (grade), timing, seriousness, and relationship to study drug.

Time frame: 84 days

Incidence of laboratory abnormalities as a measure of safety and tolerability of ERX-315

Laboratory abnormalities as characterized by type, frequency, severity, and timing.

Time frame: 84 days

Determination of the recommended phase 2 dose

To determine the recommended phase 2 dose(s) for additional evaluation of ERX-315 in clinical trials for participants with advanced solid tumors

Time frame: 84 days

Secondary Outcomes

Assessment of pharmacokinetic outcome measure of Area under the plasma concentration versus time curve (AUC).

AUC will be determined by non-compartmental analysis and assessed after single and multiple doses of drug

Time frame: 21 days

Assessment of pharmacokinetic outcome measure of Peak Plasma concentration (Cmax)

Cmax will be determined by non-compartmental analysis and assessed after single and multiple doses of drug

Time frame: 21 days

Assessment of pharmacokinetic outcome measure of drug half-life (t1/2)

t1/2 will be assessed after single and multiple doses of drug

Central Contacts

Research Director

CONTACT

01 469 600 6603 contact@etira.life

Data from ClinicalTrials.gov

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