This is the open label, multicenter Phase 1 study which consists of a dose escalation to determine the maximum tolerated dose (MTD) and cohort expansion to obtain a preliminary evaluation of anti-tumor activity. ERY974 is intravenously injected to patients with Glypican 3 positive advanced solid tumors until unacceptable toxicity or disease progression.
Completed
Phase 1
NCT ID: NCT02748837
ORG ID: ERY101EG
Solid Tumors
| Drug | Synonyms | Arms |
|---|---|---|
| ERY974 | Dose escalation cohort of ERY974, Cohort expansion in gastric cancer, Cohort expansion in esophageal carcinoma, Cohort expansion in other solid tumors |
This is the open label, multicenter Phase 1 study which consists of a dose escalation to
determine the maximum tolerated dose (MTD) and cohort expansion to obtain a preliminary
evaluation of anti-tumor activity. ERY974 is intravenously injected to patients with
Glypican 3 positive advanced solid tumors until unacceptable toxicity or disease
progression.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Dose escalation cohort of ERY974 | Experimental | Dose escalation (DE) will proceed with the dose level increment and the dose cohort size being guided by a safety evaluations during and at the end of each cohort. DE initially utilizes an accelerated titration design (ATD) and once the first dose limiting toxicity (DLT) is observed, DE will continue using a modified continual reassessment method (mCRM) until MTD. | ERY974 |
| Cohort expansion in gastric cancer | Experimental | Patients with GPC3 positive advanced gastric cancer or gastroesophageal junction cancer will receive ERY974 at recommended dose until disease progression. | ERY974 |
| Cohort expansion in esophageal carcinoma | Experimental | Patients with GPC3 positive advanced squamous cell esophageal carcinoma will receive ERY974 at recommended dose until disease progression. | ERY974 |
| Cohort expansion in other solid tumors | Experimental | Patients with other GPC3 positive advanced solid tumors will receive ERY974 at recommended dose until disease progression | ERY974 |
Inclusion Criteria:
- Male or female patient with Glypican 3 positive advanced solid tumor not amenable to
standard therapy or for which standard therapy is not available or not indicated
- Measurable tumor
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Adequate bone marrow, liver, and renal function
- Adequate coagulation status
Exclusion Criteria:
- Patients with more than a single brain metastasis ( >1 cm)
- Patients with acute or chronic infection
- Major surgery within 28 days
- Pregnant or lactating women
- Patients with interstitial pneumonitis
- Patients require regular ascites/pleural effusion drainage
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Dose escalation MTD determination
Cohort expansionPreliminary assessment of change in tumor size
Dose escalation Number and severity of adverse events
Dose escalation Plasma ERY974 concentrations
Dose escalationArea under curve (AUC)
Dose escalationterminal half-life
Dose escalationtotal clearance
Dose escalationvolume distribution
Dose escalation Change in tumor size assessed by mRECIST
Dose escalation Determining the recommended dose
Cohort expansionNumber and severity of adverse events
Cohort expansion Plasma ERY974 concentrations
Cohort expansion Area under curve (AUC)
Cohort expansion terminal half-life
Cohort expansion total clearance
Cohort expansion volume distribution
