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A Study of ERY974 in Patient With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02748837
Recruitment Status : Completed
First Posted : April 22, 2016
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical

Tracking Information
First Submitted Date  ICMJE March 29, 2016
First Posted Date  ICMJE April 22, 2016
Last Update Posted Date August 22, 2019
Study Start Date  ICMJE August 2016
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2017)
  • 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 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) [ 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ERY974 in Patient With Advanced Solid Tumors
Official Title  ICMJE A Phase 1 Dose Escalation and Cohort Expansion Study of ERY974, An Anti-Glypican3 (GPC3)/CD3 Bispecific Antibody, in Patients With Advanced Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE Drug: ERY974
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: 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
    Intervention: Drug: ERY974
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2019)
29
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2016)
125
Actual Study Completion Date  ICMJE August 2019
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02748837
Other Study ID Numbers  ICMJE ERY101EG
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chugai Pharmaceutical
Study Sponsor  ICMJE Chugai Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sponsor Chugai Pharmaceutical Co. Ltd clinical-trials@chugai-pharm.co.jp
PRS Account Chugai Pharmaceutical
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP