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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
20/11/2024

Titles & IDs
Public title
A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
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
Secondary ID [1] 0 0
ERX-315-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Metastatic Breast Cancer 0 0
Metastatic Ovarian Cancer 0 0
Metastatic Endometrial Cancer 0 0
Metastatic Liver Cancer 0 0
Metastatic Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Dose Limiting Toxicities of ERX-315
Timepoint [1] 0 0
21 days
Primary outcome [2] 0 0
Incidence of Adverse Events as a measure of safety and tolerability of ERX-315
Timepoint [2] 0 0
84 days
Primary outcome [3] 0 0
Incidence of laboratory abnormalities as a measure of safety and tolerability of ERX-315
Timepoint [3] 0 0
84 days
Primary outcome [4] 0 0
Determination of the recommended phase 2 dose
Timepoint [4] 0 0
84 days
Secondary outcome [1] 0 0
Assessment of pharmacokinetic outcome measure of Area under the plasma concentration versus time curve (AUC).
Timepoint [1] 0 0
21 days
Secondary outcome [2] 0 0
Assessment of pharmacokinetic outcome measure of Peak Plasma concentration (Cmax)
Timepoint [2] 0 0
21 days
Secondary outcome [3] 0 0
Assessment of pharmacokinetic outcome measure of drug half-life (t1/2)
Timepoint [3] 0 0
21 days
Secondary outcome [4] 0 0
Antitumor activity of ERX-315 based on Objective response rate (ORR)
Timepoint [4] 0 0
84 days
Secondary outcome [5] 0 0
Antitumor activity of ERX-315 based on Best Overall Clinical Response (BOCR)
Timepoint [5] 0 0
84 days
Secondary outcome [6] 0 0
Antitumor activity of ERX-315 based on Duration of response (DOR)
Timepoint [6] 0 0
84 days
Secondary outcome [7] 0 0
Antitumor activity of ERX-315 based on Progression-free survival (PFS)
Timepoint [7] 0 0
84 days

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2025
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
The Kinghorn Cancer Center - Sydney
Recruitment hospital [2] 0 0
Cancer Research SA - Adelaide
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
EtiraRx Australia Pty Ltd
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06533332
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rasha Cosman, MBBS
Address 0 0
The Kinghorn Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Research Director
Address 0 0
Country 0 0
Phone 0 0
01 469 600 6603
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06533332