A Study of ERY974 in Patient With Advanced Solid Tumors

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748837
• Other study ID #: ERY101EG
• Status: Completed
• Phase: Phase 1
• Start date: August 2016
• Est. completion date: August 2019

Study information

• Verified date: August 2019
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• ERY974

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Countries where clinical trial is conducted

United States,  France,  Netherlands, 

Outcome

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