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Trial record 10 of 30 for:    cancer | First posted from 04/22/2016 to 04/22/2016

A Study of ERY974 in Patient With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02748837
Recruitment Status : Suspended (New recruitment to the study is temporarily stopped pending sponsor assessment of data)
First Posted : April 22, 2016
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: ERY974 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
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
Study Start Date : August 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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)

  2. 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 :
  1. Dose escalation: Number and severity of adverse events [ Time Frame: Adverse events will be reported through 28 days after the last dose ]
  2. Dose escalation: Plasma ERY974 concentrations [ Time Frame: 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 ]
  3. Dose escalation:Area under curve (AUC) [ Time Frame: 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 ]
  4. Dose escalation:terminal half-life [ Time Frame: 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 ]
  5. Dose escalation:total clearance [ Time Frame: 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 ]
  6. Dose escalation:volume distribution [ Time Frame: 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 ]
  7. 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 ]
  8. 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. ]
  9. Cohort expansion:Number and severity of adverse events [ Time Frame: Adverse events will be reported through 28 days after the last dose ]
  10. Cohort expansion :Plasma ERY974 concentrations [ Time Frame: 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 ]
  11. Cohort expansion :Area under curve (AUC) [ Time Frame: 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 ]
  12. Cohort expansion :terminal half-life [ Time Frame: 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 ]
  13. Cohort expansion :total clearance [ Time Frame: 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 ]
  14. Cohort expansion :volume distribution [ Time Frame: 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Tampa, Florida, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
United States, New York
New York, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Rhode Island
Providence, Rhode Island, United States
France
Paris, France
Villejuif, France
Netherlands
Groningen, Netherlands
Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Director: Sponsor Chugai Pharmaceutical Co. Ltd clinical-trials@chugai-pharm.co.jp

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT02748837     History of Changes
Other Study ID Numbers: ERY101EG
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018