A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors
NCT Number: NCT06533332
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Solid Tumor|Metastatic Breast Cancer|Metastatic Ovarian Cancer|Metastatic Endometrial Cancer|Metastatic Liver Cancer|Metastatic Pancreatic Cancer
Interventions: DRUG: ERX-315
Sponsor: EtiraRx Australia Pty Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-22
Completion Date: 2025-08-30
Locations: The Kinghorn Cancer Center, Sydney, New South Wales, 2010, Australia

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.

Primary Outcome Measures: 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: 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
Other Outcome Measures: 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, 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