Advanced Solid Tumor, Metastatic Breast Cancer, Metastatic Endometrial Cancer, Metastatic Liver Cancer, Metastatic Ovarian Cancer, Metastatic Pancreatic Cancer
Conditions
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.
Interventions
DRUGERX-315
Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg.
Sponsors
EtiraRx Australia Pty Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of pharmacokinetic outcome measure of Area under the plasma concentration versus time curve (AUC). | 21 days | AUC will be determined by non-compartmental analysis and assessed after single and multiple doses of drug |
| Assessment of pharmacokinetic outcome measure of Peak Plasma concentration (Cmax) | 21 days | Cmax will be determined by non-compartmental analysis and assessed after single and multiple doses of drug |
| Assessment of pharmacokinetic outcome measure of drug half-life (t1/2) | 21 days | t1/2 will be assessed after single and multiple doses of drug |
| Antitumor activity of ERX-315 based on Objective response rate (ORR) | 84 days | ORR will be assessed by RECIST v1.1 |
| Antitumor activity of ERX-315 based on Best Overall Clinical Response (BOCR) | 84 days | BOCR will be assessed by RECIST v1.1 |
| Antitumor activity of ERX-315 based on Duration of response (DOR) | 84 days | DOR will be assessed by RECIST v1.1 and time frame of response |
| Antitumor activity of ERX-315 based on Progression-free survival (PFS) | 84 days | PFS will be assessed by RECIST v1.1 and time frame of response |
Countries
Australia
Contacts
CONTACTResearch Director
PRINCIPAL_INVESTIGATORRasha Cosman, MBBS
The Kinghorn Cancer Centre
Outcome results
None listed