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Trial record 9 of 30 for:    cancer | First posted from 04/22/2016 to 04/22/2016

A Study of ERY974 in Patient With Advanced Solid Tumors

This study is currently recruiting participants.
Verified January 2017 by Chugai Pharmaceutical
Sponsor:
ClinicalTrials.gov Identifier:
NCT02748837
First Posted: April 22, 2016
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Chugai Pharmaceutical
  Purpose
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.

Condition Intervention Phase
Solid Tumors Drug: ERY974 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • Dose escalation: MTD determination [ Time Frame: DLT evaluation period, defined as from the first ERY974 injection until 7 days after the third injection ]
    Determination of dose-limiting toxicities (DLT)

  • Cohort expansion:Preliminary assessment of change in tumor size [ Time Frame: 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 ]
    Anti-tumor activity will be assessed by modified Response Evaluation Criteria in Solid Tumors (mRECIST)


Secondary Outcome Measures:
  • Dose escalation: Number and severity of adverse events [ Time Frame: Adverse events will be reported through 28 days after the last dose ]
  • Dose escalation: Plasma ERY974 concentrations [ Time Frame: PK will be assessed from day 1 to day 8, from day15 to day17, and every 3weeks from day 22 until end of treatment visit, up to 38 months ]
  • Dose escalation:Area under curve (AUC) [ Time Frame: PK will be assessed from day 1 to day 8, from day15 to day17, and every 3weeks from day 22 until end of treatment visit, up to 38 months ]
  • Dose escalation:terminal half-life [ Time Frame: PK will be assessed from day 1 to day 8, from day15 to day17, and every 3weeks from day 22 until end of treatment visit, up to 38 months ]
  • Dose escalation:total clearance [ Time Frame: PK will be assessed from day 1 to day 8, from day15 to day17, and every 3weeks from day 22 until end of treatment visit, up to 38 months ]
  • Dose escalation:volume distribution [ Time Frame: PK will be assessed from day 1 to day 8, from day15 to day17, and every 3weeks from day 22 until end of treatment visit, up to 38 months ]
  • Dose escalation: Change in tumor size assessed by mRECIST [ Time Frame: 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 ]
  • Dose escalation: Determining the recommended dose [ Time Frame: 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. ]
  • Cohort expansion:Number and severity of adverse events [ Time Frame: Adverse events will be reported through 28 days after the last dose ]
  • Cohort expansion :Plasma ERY974 concentrations [ Time Frame: PK will be assessed from day 1 to day 8, from day15 to day17, and every 3weeks from day 22 until end of treatment visit, up to 38 months ]
  • Cohort expansion :Area under curve (AUC) [ Time Frame: PK will be assessed from day 1 to day 8, from day15 to day17, and every 3weeks from day 22 until end of treatment visit, up to 38 months ]
  • Cohort expansion :terminal half-life [ Time Frame: PK will be assessed from day 1 to day 8, from day15 to day17, and every 3weeks from day 22 until end of treatment visit, up to 38 months ]
  • Cohort expansion :total clearance [ Time Frame: PK will be assessed from day 1 to day 8, from day15 to day17, and every 3weeks from day 22 until end of treatment visit, up to 38 months ]
  • Cohort expansion :volume distribution [ Time Frame: PK will be assessed from day 1 to day 8, from day15 to day17, and every 3weeks from day 22 until end of treatment visit, up to 38 months ]

Estimated Enrollment: 125
Study Start Date: August 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose escalation cohort of ERY974
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
Experimental: Cohort expansion in gastric cancer
Patients with GPC3 positive advanced gastric cancer or gastroesophageal junction cancer will receive ERY974 at recommended dose until disease progression.
Drug: ERY974
Experimental: Cohort expansion in esophageal carcinoma
Patients with GPC3 positive advanced squamous cell esophageal carcinoma will receive ERY974 at recommended dose until disease progression.
Drug: ERY974
Experimental: Cohort expansion in other solid tumors
Patients with other GPC3 positive advanced solid tumors will receive ERY974 at recommended dose until disease progression
Drug: ERY974

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748837


Contacts
Contact: Joris de bie clinical-trials@chugai-pharm.co.jp

Locations
United States, District of Columbia
Not yet recruiting
Washington, DC, District of Columbia, United States
United States, Florida
Recruiting
Tampa, Florida, United States
United States, Michigan
Recruiting
Detroit, Michigan, United States
United States, New York
Recruiting
New York, New York, United States
United States, Rhode Island
Recruiting
Providence, Rhode Island, United States
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Director: Sponsor Chugai Pharmaceutical Co. Ltd clinical-trials@chugai-pharm.co.jp
  More Information

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT02748837     History of Changes
Other Study ID Numbers: ERY101EG
First Submitted: March 29, 2016
First Posted: April 22, 2016
Last Update Posted: January 27, 2017
Last Verified: January 2017