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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERX-315 | Experimental | Active investigational therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERX-315 | Drug | Drug administered intravenously twice a week at increasing dose levels, with starting dose of 0.4mg/kg. |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Impact on patient reported symptoms using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire | Effect of ERX-315 on the changes from baseline in patient reported symptoms using the PRO-CTCAE Questionnaire | 84 days |
| Serum LIPA lipase activity as pharmacodynamic markers of ERX-315 activity |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Director | Contact | 01 469 600 6603 | contact@etira.life |
| Name | Affiliation | Role |
|---|---|---|
| Rasha Cosman, MBBS | The Kinghorn Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macquarie University Health | Recruiting | Ryde | New South Wales | 2109 | Australia |
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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 |
The effect of ERX-315 on serum LIPA lipase activity may be evaluated |
| 84 days |
| Circulating tumor DNA levels as pharmacodynamic markers of ERX-315 activity | The effect of ERX-315 on circulating tumor DNA levels may be evaluated | 84 days |
| The Kinghorn Cancer Center | Recruiting | Sydney | New South Wales | 2010 | Australia |
| Westmead Hospital | Recruiting | Westmead | New South Wales | 2145 | Australia |
|
| Cancer Research SA | Recruiting | Adelaide | South Australia | 5000 | Australia |
|
| Icon Cancer Centre Adelaide | Recruiting | Adelaide | South Australia | 5037 | Australia |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| D008113 | Liver Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D010182 | Pancreatic Diseases |
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