A Study of ERY974 in Patient With Advanced Solid Tumors

Chugai Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: ERY974

Study type: Interventional

Funder types: Industry

Identifiers

NCT02748837

ERY101EG

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 4 patient groups

Dose escalation cohort of ERY974

Experimental group

Description:

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.

Treatment:

Drug: ERY974

Cohort expansion in gastric cancer

Experimental group

Description:

Patients with GPC3 positive advanced gastric cancer or gastroesophageal junction cancer will receive ERY974 at recommended dose until disease progression.

Treatment:

Drug: ERY974

Cohort expansion in esophageal carcinoma

Experimental group

Description:

Patients with GPC3 positive advanced squamous cell esophageal carcinoma will receive ERY974 at recommended dose until disease progression.

Treatment:

Drug: ERY974

Cohort expansion in other solid tumors

Experimental group

Description:

Patients with other GPC3 positive advanced solid tumors will receive ERY974 at recommended dose until disease progression

Treatment:

Drug: ERY974