Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 4:10 PM
Study NCT ID:
NCT06533332
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2024-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2024-07-22', 'studyFirstSubmitQcDate': '2024-07-29', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Impact on patient reported symptoms using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire', 'timeFrame': '84 days', 'description': 'Effect of ERX-315 on the changes from baseline in patient reported symptoms using the PRO-CTCAE Questionnaire'}, {'measure': 'Serum LIPA lipase activity as pharmacodynamic markers of ERX-315 activity', 'timeFrame': '84 days', 'description': 'The effect of ERX-315 on serum LIPA lipase activity may be evaluated'}, {'measure': 'Circulating tumor DNA levels as pharmacodynamic markers of ERX-315 activity', 'timeFrame': '84 days', 'description': 'The effect of ERX-315 on circulating tumor DNA levels may be evaluated'}], 'primaryOutcomes': [{'measure': 'Incidence of Dose Limiting Toxicities of ERX-315', 'timeFrame': '21 days', 'description': 'First cycle dose limiting toxicities characterized by type, frequency, severity, timing, seriousness, and relationship to study drug'}, {'measure': 'Incidence of Adverse Events as a measure of safety and tolerability of ERX-315', 'timeFrame': '84 days', 'description': 'Adverse events as characterized by type, frequency, severity (grade), timing, seriousness, and relationship to study drug.'}, {'measure': 'Incidence of laboratory abnormalities as a measure of safety and tolerability of ERX-315', 'timeFrame': '84 days', 'description': 'Laboratory abnormalities as characterized by type, frequency, severity, and timing.'}, {'measure': 'Determination of the recommended phase 2 dose', 'timeFrame': '84 days', 'description': 'To determine the recommended phase 2 dose(s) for additional evaluation of ERX-315 in clinical trials for participants with advanced solid tumors'}], 'secondaryOutcomes': [{'measure': 'Assessment of pharmacokinetic outcome measure of Area under the plasma concentration versus time curve (AUC).', 'timeFrame': '21 days', 'description': 'AUC will be determined by non-compartmental analysis and assessed after single and multiple doses of drug'}, {'measure': 'Assessment of pharmacokinetic outcome measure of Peak Plasma concentration (Cmax)', 'timeFrame': '21 days', 'description': 'Cmax will be determined by non-compartmental analysis and assessed after single and multiple doses of drug'}, {'measure': 'Assessment of pharmacokinetic outcome measure of drug half-life (t1/2)', 'timeFrame': '21 days', 'description': 't1/2 will be assessed after single and multiple doses of drug'}, {'measure': 'Antitumor activity of ERX-315 based on Objective response rate (ORR)', 'timeFrame': '84 days', 'description': 'ORR will be assessed by RECIST v1.1'}, {'measure': 'Antitumor activity of ERX-315 based on Best Overall Clinical Response (BOCR)', 'timeFrame': '84 days', 'description': 'BOCR will be assessed by RECIST v1.1'}, {'measure': 'Antitumor activity of ERX-315 based on Duration of response (DOR)', 'timeFrame': '84 days', 'description': 'DOR will be assessed by RECIST v1.1 and time frame of response'}, {'measure': 'Antitumor activity of ERX-315 based on Progression-free survival (PFS)', 'timeFrame': '84 days', 'description': 'PFS will be assessed by RECIST v1.1 and time frame of response'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumor', 'Metastatic Breast Cancer', 'Metastatic Ovarian Cancer', 'Metastatic Endometrial Cancer', 'Metastatic Liver Cancer', 'Metastatic Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be at least 18 years of age at the time of signing the informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* 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\n* Patients must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Adequate baseline organ function and hematologic function\n* Life expectancy \\>3 months\n\nExclusion Criteria:\n\n* Systemic anti cancer therapy within 4 weeks of first dose of study drug\n* Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.\n* Uncontrolled intercurrent illnesses\n* Known history of LIPA deficiency, such as Wolman disease or Cholesterol ester storage disease.'}, 'identificationModule': {'nctId': 'NCT06533332', 'briefTitle': 'A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'EtiraRx Australia Pty Ltd'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ERX-315-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ERX-315', 'description': 'Active investigational therapy', 'interventionNames': ['Drug: ERX-315']}], 'interventions': [{'name': 'ERX-315', 'type': 'DRUG', 'description': 'Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg.', 'armGroupLabels': ['ERX-315']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2109', 'city': 'Ryde', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'email': 'reception@muh.org.au', 'phone': '+61 (2) 9812 3000'}, {'name': 'Danusha Sabanathan, BSc(Med) MBBS MMed FRACP PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Macquarie University Health', 'geoPoint': {'lat': -33.8188, 'lon': 151.1062}}, {'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'The Kinghorn Cancer Center', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Kelly Mead', 'role': 'CONTACT', 'email': 'admin@crsa.au', 'phone': '08 8359 2565'}, {'name': 'Rohit Joshi, MBBS, FRACP, MD, FACP, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Research SA', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '5037', 'city': 'Adelaide', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'email': 'admin.adelaide@icon.team', 'phone': '08 8474 0220'}, {'name': 'Anna Mislang, MBBS, FRACP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Icon Cancer Centre Adelaide', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'centralContacts': [{'name': 'Research Director', 'role': 'CONTACT', 'email': 'contact@etira.life', 'phone': '01 469 600 6603'}], 'overallOfficials': [{'name': 'Rasha Cosman, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Kinghorn Cancer Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EtiraRx Australia Pty Ltd', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}