A Phase 1 Trial Of ERX-315 In Participants With Advanced Solid Tumors

Study Overview

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.

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.

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

DRUG: ERX-315

ERX-315-101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-07-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-30
First Submitted that Met QC Criteria 2024-07-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-06-04
First Posted (ACTUAL) 2024-08-01	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: ERX-315 Active investigational therapy	DRUG: ERX-315 Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: ERX-315

Active investigational therapy

DRUG: ERX-315

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

Primary Outcome Measures	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 Measures	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Research Director

Phone Number: 01 469 600 6603

Email: contact@etira.life

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Rasha Cosman, MBBS, The Kinghorn Cancer Centre

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record