A Study of ERY974 in Patient With Advanced Solid Tumors
Status: | Active, not recruiting |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/8/2019 |
Start Date: | August 2016 |
End Date: | December 2019 |
A Phase 1 Dose Escalation and Cohort Expansion Study of ERY974, An Anti-Glypican3 (GPC3)/CD3 Bispecific Antibody, in Patients With Advanced 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.
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.
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
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