Solid TumorsPhase 1NCT02748837
A Study of ERY974 in Patient With Advanced Solid Tumors
A Phase 1 study testing ERY974 in people with Solid Tumors, run by Chugai Pharmaceutical at 10 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- ERY974
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Aug 2016to Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States7 sites
Study site
Boston, Massachusetts
Study site
Detroit, Michigan
Study site
Durham, North Carolina
Study site
New York, New York
Study site
Providence, Rhode Island
Study site
Tampa, Florida
Study site
Washington D.C., District of Columbia
About this study
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
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
- Being tested
- ERY974
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERY974Drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 Receives: Drug: ERY974 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose escalation： MTD determination
Determination of dose-limiting toxicities (DLT)
Measured: 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)
Measured: 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
Measured: Adverse events will be reported through 28 days after the last dose
Dose escalation： Plasma ERY974 concentrations
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Adverse events will be reported through 28 days after the last dose
Cohort expansion ：Plasma ERY974 concentrations
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor Chugai Pharmaceutical Co. Ltd, Study director, clinical-trials@chugai-pharm.co.jp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748837
- Sponsor's protocol ID
- ERY101EG
- Status last verified
- Aug 2019
- First submitted
- 29 Mar 2016
- Last updated
- 22 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02748837
- Acronym / sponsor ID
- ERY101EG
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose escalation cohort of ERY974 | Experimental | Drug: ERY974Dose 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. |
| Cohort expansion in gastric cancer | Experimental | Drug: ERY974Patients with GPC3 positive advanced gastric cancer or gastroesophageal junction cancer will receive ERY974 at recommended dose until disease progression. |
| Cohort expansion in esophageal carcinoma | Experimental | Drug: ERY974Patients with GPC3 positive advanced squamous cell esophageal carcinoma will receive ERY974 at recommended dose until disease progression. |
| Cohort expansion in other solid tumors | Experimental | Drug: ERY974Patients with other GPC3 positive advanced solid tumors will receive ERY974 at recommended dose until disease progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERY974 | Drug | Cohort expansion in esophageal carcinoma, Cohort expansion in gastric cancer, Cohort expansion in other solid tumors, Dose escalation cohort of ERY974 |
Primary outcome
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)
14 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sponsor Chugai Pharmaceutical Co. Ltd study director
clinical-trials@chugai-pharm.co.jp
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ERY974 in people with Solid Tumors, run by Chugai Pharmaceutical at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose escalation： MTD determination (time frame: DLT evaluation period, defined as from the first ERY974 injection until 7 days after the third injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.