Solid Tumors Clinical Trial
Official title:
A Phase 1 Dose Escalation and Cohort Expansion Study of ERY974, An Anti-Glypican3 (GPC3)/CD3 Bispecific Antibody, in Patients With Advanced Solid Tumors
NCT number | NCT02748837 |
Other study ID # | ERY101EG |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | August 2019 |
Verified date | August 2019 |
Source | Chugai Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | August 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chugai Pharmaceutical |
United States, France, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose escalation: MTD determination | Determination of dose-limiting toxicities (DLT) | DLT evaluation period, defined as from the first ERY974 injection until 7 days after the third injection | |
Primary | Cohort expansion:Preliminary assessment of change in tumor size | Anti-tumor activity will be assessed by modified Response Evaluation Criteria in Solid Tumors (mRECIST) | From the date of informed consents obtained until disease progression: at screening , week 6,12,18 and subsequently every 3 months up to 38 months | |
Secondary | Dose escalation: Number and severity of adverse events | Adverse events will be reported through 28 days after the last dose | ||
Secondary | Dose escalation: Plasma ERY974 concentrations | PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months | ||
Secondary | Dose escalation:Area under curve (AUC) | PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months | ||
Secondary | Dose escalation:terminal half-life | PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months | ||
Secondary | Dose escalation:total clearance | PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months | ||
Secondary | Dose escalation:volume distribution | PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months | ||
Secondary | Dose escalation: Change in tumor size assessed by mRECIST | From the date of informed consents obtained until disease progression: at screening , week 6,12,18 and subsequently every 3 months up to 38 months | ||
Secondary | Dose escalation: Determining the recommended dose | Recommended dose will be determined after completion of DLT assessments in all dose escalation cohorts. It is estimated as 18 months after first patient enrollment. | ||
Secondary | Cohort expansion:Number and severity of adverse events | Adverse events will be reported through 28 days after the last dose | ||
Secondary | Cohort expansion :Plasma ERY974 concentrations | PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months | ||
Secondary | Cohort expansion :Area under curve (AUC) | PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months | ||
Secondary | Cohort expansion :terminal half-life | PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months | ||
Secondary | Cohort expansion :total clearance | PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months | ||
Secondary | Cohort expansion :volume distribution | PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months |
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