A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
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.
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT06533332
Intervention or treatment
DRUG: ERX-315
Conditions
- Advanced Solid Tumor
- Metastatic Breast Cancer
- Metastatic Ovarian Cancer
- Metastatic Endometrial Cancer
- Metastatic Liver Cancer
- Metastatic Pancreatic Cancer
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Macquarie University Health
Select from list below to view details:
Macquarie University Health
Ryde, New South Wales, Australia
The Kinghorn Cancer Center
Sydney, New South Wales, Australia
Cancer Research SA
Adelaide, South Australia, Australia
Icon Cancer Centre Adelaide
Adelaide, South Australia, Australia
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Who is running the clinical trial?
EtiraRx Australia Pty Ltd
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: ERX-315
| Drug: ERX-315 |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | 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 | 84 days |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 21 days |
| Antitumor activity of ERX-315 based on Objective response rate (ORR) | ORR will be assessed by RECIST v1.1 | 84 days |
| Antitumor activity of ERX-315 based on Best Overall Clinical Response (BOCR) | BOCR will be assessed by RECIST v1.1 | 84 days |
| Antitumor activity of ERX-315 based on Duration of response (DOR) | DOR will be assessed by RECIST v1.1 and time frame of response | 84 days |
| Antitumor activity of ERX-315 based on Progression-free survival (PFS) | PFS will be assessed by RECIST v1.1 and time frame of response | 84 days |
References
Clinical Trials Gov: A Phase 1 Trial of ERX-315 in Participants With Advanced Solid TumorsOther trials to consider
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