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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06533332
Registration number
NCT06533332
Ethics application status
Date submitted
22/07/2024
Date registered
1/08/2024
Date last updated
4/06/2025
Titles & IDs
Public title
A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
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Scientific 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
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Secondary ID [1]
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ERX-315-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor
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Metastatic Breast Cancer
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Metastatic Ovarian Cancer
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Metastatic Endometrial Cancer
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Metastatic Liver Cancer
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Metastatic Pancreatic Cancer
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ERX-315
Experimental: ERX-315 - Active investigational therapy
Treatment: Drugs: ERX-315
Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Dose Limiting Toxicities of ERX-315
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Assessment method [1]
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First cycle dose limiting toxicities characterized by type, frequency, severity, timing, seriousness, and relationship to study drug
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Timepoint [1]
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21 days
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Primary outcome [2]
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Incidence of Adverse Events as a measure of safety and tolerability of ERX-315
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Assessment method [2]
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Adverse events as characterized by type, frequency, severity (grade), timing, seriousness, and relationship to study drug.
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Timepoint [2]
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84 days
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Primary outcome [3]
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Incidence of laboratory abnormalities as a measure of safety and tolerability of ERX-315
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Assessment method [3]
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Laboratory abnormalities as characterized by type, frequency, severity, and timing.
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Timepoint [3]
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84 days
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Primary outcome [4]
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Determination of the recommended phase 2 dose
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Assessment method [4]
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To determine the recommended phase 2 dose(s) for additional evaluation of ERX-315 in clinical trials for participants with advanced solid tumors
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Timepoint [4]
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84 days
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Secondary outcome [1]
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Assessment of pharmacokinetic outcome measure of Area under the plasma concentration versus time curve (AUC).
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Assessment method [1]
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AUC will be determined by non-compartmental analysis and assessed after single and multiple doses of drug
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Timepoint [1]
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21 days
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Secondary outcome [2]
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Assessment of pharmacokinetic outcome measure of Peak Plasma concentration (Cmax)
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Assessment method [2]
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Cmax will be determined by non-compartmental analysis and assessed after single and multiple doses of drug
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Timepoint [2]
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21 days
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Secondary outcome [3]
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Assessment of pharmacokinetic outcome measure of drug half-life (t1/2)
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Assessment method [3]
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t1/2 will be assessed after single and multiple doses of drug
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Timepoint [3]
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21 days
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Secondary outcome [4]
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Antitumor activity of ERX-315 based on Objective response rate (ORR)
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Assessment method [4]
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ORR will be assessed by RECIST v1.1
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Timepoint [4]
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84 days
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Secondary outcome [5]
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Antitumor activity of ERX-315 based on Best Overall Clinical Response (BOCR)
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Assessment method [5]
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BOCR will be assessed by RECIST v1.1
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Timepoint [5]
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84 days
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Secondary outcome [6]
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Antitumor activity of ERX-315 based on Duration of response (DOR)
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Assessment method [6]
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DOR will be assessed by RECIST v1.1 and time frame of response
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Timepoint [6]
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84 days
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Secondary outcome [7]
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Antitumor activity of ERX-315 based on Progression-free survival (PFS)
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Assessment method [7]
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PFS will be assessed by RECIST v1.1 and time frame of response
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Timepoint [7]
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84 days
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/10/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
15
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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The Kinghorn Cancer Center - Sydney
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Recruitment hospital [2]
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MQ Health Medical Oncology and Clinical Trials/Macquarie University - Sydney
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Recruitment hospital [3]
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Cancer Research SA - Adelaide
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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2109 - Sydney
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Other
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Name
EtiraRx Australia Pty Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06533332
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Rasha Cosman, MBBS
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Address
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The Kinghorn Cancer Centre
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Research Director
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Address
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Country
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Phone
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01 469 600 6603
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06533332
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