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A Study of ERY974 in Patient With Advanced Solid Tumors

Sponsor
Chugai Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT02748837
Collaborator
(none)
29
Enrollment
10
Locations
4
Arms
36
Duration (Months)
2.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
29 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 :
Aug 1, 2016
Actual Primary Completion Date :
Aug 1, 2019
Actual Study Completion Date :
Aug 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Dose escalation： MTD determination [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 [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 [Adverse events will be reported through 28 days after the last dose]

  2. 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]

  3. 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]

  4. 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]

  5. 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]

  6. 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]

  7. 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]

  8. 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.]

  9. Cohort expansion：Number and severity of adverse events [Adverse events will be reported through 28 days after the last dose]

  10. 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]

  11. 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]

  12. 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]

  13. 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]

  14. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Washington District of Columbia United States
2 Tampa Florida United States
3 Boston Massachusetts United States
4 Detroit Michigan United States
5 New York New York United States
6 Durham North Carolina United States
7 Providence Rhode Island United States
8 Paris France
9 Villejuif France
10 Groningen Netherlands

Sponsors and Collaborators

  • Chugai Pharmaceutical

Investigators

  • Study Director: Sponsor Chugai Pharmaceutical Co. Ltd, clinical-trials@chugai-pharm.co.jp

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT02748837
Other Study ID Numbers:
  • ERY101EG
First Posted:
Apr 22, 2016
Last Update Posted:
Aug 22, 2019
Last Verified:
Aug 1, 2019
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Aug 22, 2019