A Study of ERY974 in Patient With Advanced Solid Tumors

NCT02748837 | Completed Phase 1

• 1 other identifier: ERY101EG
• Study Type: interventional
• Target: 29
• Locations: 3 countries
• Sites: 10

Brief 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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (14)

• Dose escalation： Number and severity of adverse events

  Adverse events will be reported through 28 days after the last dose

• 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

• 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

• 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

• 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

Study Arms (4)

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.

Drug: 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.

Drug: 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.

Drug: 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

Drug: ERY974

Interventions

ERY974 DRUG

Cohort expansion in esophageal carcinoma; Cohort expansion in gastric cancer; Cohort expansion in other solid tumors; Dose escalation cohort of ERY974

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chugai Pharmaceutical: lead

Study Sites (10)

Unknown Facility

Washington D.C., District of Columbia, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Providence, Rhode Island, United States

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Villejuif, France

Location

Unknown Facility

Groningen, Netherlands

Location

MeSH Terms

Interventions

bispecific antibody ERY974

Study Officials

• Sponsor Chugai Pharmaceutical Co. Ltd

  clinical-trials@chugai-pharm.co.jp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 22, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Locations

FR (2); US (7); NL (1)