Gastric CancerNCT03528629
A Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
A study testing Zolbetuximab in people with Gastric Cancer and Gastro-esophageal Junction (GEJ) Cancer, run by Astellas Pharma Inc at 1 site in Japan.
Trial summary
The purpose of this study is to assess the safety, tolerability and antitumor activity of IMAB362 in Japanese subjects with locally advanced or metastatic Gastric or GEJ adenocarcinoma whose tumors have Claudin (CLDN) 18.2 Expression. This study will also assess pharmacokinetics and immunogenicity of IMAB362. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer, Gastro-esophageal Junction (GEJ) Cancer
- What is being tested?
- Zolbetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteJapan
- Study dates
- 8 Jun 2018to 9 Jun 2020
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has histologically or cytologically confirmed diagnosis of gastric or gastro-esophageal junction adenocarcinoma.
- Subject has gastric or gastroesophageal junction (GEJ) adenocarcinoma based on radiographic imaging or endoscopic examination.
- Subject agrees not to participate in another interventional study while on treatment.
- Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Subject has predicted life expectancy ≥ 12 weeks.
- Subject must have an available tumor specimen collected at any time prior to the first dose of study treatment.
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- Subject must meet all of the pre-specified criteria on the laboratory tests that will be analyzed locally within 7 days prior to the first dose of study drug.
- Locally advanced or Metastatic gastric or GEJ adenocarcinoma with no standard of care treatment option or subject is ineligible to receive available standard of care treatment option.
- Subject's tumor sample has Claudin (CLDN)18.2 membranous staining with any intensity as determined by central Immunohistochemistry (IHC) testing. (Safety part only)
- Subject has CLDN18.2 high expression in ≥75% of tumor cells demonstrating moderate to strong membranous staining as determined by central IHC testing. (Expansion Part Only)
- Subject is an appropriate candidate for a tumor biopsy and is amenable to undergo a tumor biopsy during the Screening period and on-treatment tumor biopsy. (Expansion Part Only)
- Subject has at least 1 measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 within 28 days prior to the first dose of study treatment. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy. (Expansion Part Only)
Who cannot join
- Subject has prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies.
- Subject has had radiotherapy within 2 weeks prior to first dose of study drug. Subject who received palliative radiotherapy to peripheral bone metastases within 2 weeks prior to first dose of study drug and has recovered from all acute toxicities is allowed.
- Subject has received other investigational agents or devices concurrently or within 4 weeks prior first dose of study drug.
- Subject has received systemic immunosuppressive therapy, including systemic corticosteroids 2 weeks prior to first dose of study drug. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent are allowed.
- Subject has gastric outlet syndrome or persistent recurrent vomiting.
- Subject has uncontrolled or significant gastrointestinal hemorrhage.
Show all 19Show fewer
- Subject has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection.
- Subject has a positive test for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (anti-HCV). Subjects who are negative for HBsAg, but hepatitis B core antibody (HBcAb) positive, hepatitis B virus deoxyribonucleic acid (DNA) test will be performed and if positive will be excluded. Subjects with positive serology but negative HCV ribonucleic acid (RNA) test results are eligible.
- Subject has had within 6 months prior to first dose of study treatment any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure
- Subject has active infection requiring systemic therapy.
- Subject has clinically significant other disease or co-morbidity, which may adversely affect the safe delivery of treatment within this trial.
- Subject has psychiatric illness or social situations that would preclude study compliance.
- Subject has active autoimmune disease that has required systemic immunosuppressive treatment in the past 2 years.
- Subject has had a major surgical procedure within 28 days prior to the first dose of study drug.
- Subject has Fridericia-corrected QT interval (QTcF) > 450 msec for males and > 470 msec for females on 12-lead electrocardiogram (ECG) at screening based on local testing.
- Subject has any condition which makes the subject unsuitable for study participation.
- Subject has another active malignancy which is likely to require treatment.
- Subjects who find it difficult to adhere to the provisions of treatment and observation specified in the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Open-label Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
The purpose of this study is to assess the safety, tolerability and antitumor activity of IMAB362 in Japanese subjects with locally advanced or metastatic Gastric or GEJ adenocarcinoma whose tumors have Claudin (CLDN) 18.2 Expression. This study will also assess pharmacokinetics and immunogenicity of IMAB362.
Read the detailed description
This study consists of two parts (Part 1: Safety; and Part 2: Expansion). First, the subjects will be enrolled in Safety Part with IMAB362 dose-1/2 (Arm A). Then the safety and tolerability of Arm A will be evaluated at Tolerability Evaluation Meeting (TEM). If there are no safety and tolerability concerns, enrollment for the Safety Part with IMAB362 dose-3 (Arm B) and the Expansion Part with IMAB362 dose-1/2 will be opened. For each part, participants who continue to derive clinical benefit and do not have intolerable toxicity from study treatment will be allowed to remain on treatment until treatment discontinuation criterion is met.
- Being tested
- Zolbetuximab
- Keywords
- zolbetuximab, IMAB362, pharmacokinetics, tolerability, safety, ASP8951, immunogenicity
- Medical subject headings
- Stomach Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZolbetuximabDrug
Also called IMAB362
Zolbetuximab will be administered as a 2-hour intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Safety Part Arm A (IMAB362 dose-1/2) | Experimental | Participants will receive a loading dose-1 of IMAB362 on Cycle 1 Day 1 followed by a lower dose-2 in subsequent every 3 weeks. Receives: Drug: Zolbetuximab |
| Safety Part Arm B (IMAB362 dose-3) | Experimental | Participants will receive a loading dose-3 of IMAB362 on Day 1 of each cycle (every 3 weeks). Receives: Drug: Zolbetuximab |
| Expansion Part (IMAB362 dose-1/2) | Experimental | Participants will receive a loading dose-1 of IMAB362 on Cycle 1 Day 1 followed by a lower dose-2 in subsequent every 3 weeks. Receives: Drug: Zolbetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLT) in Safety Part
Any of the IMAB362 related AEs specified as the DLTs will be assessed during the first 3 weeks.
Measured: Up to Day 22
Safety and tolerability assessed by incidence of adverse events (AEs) in Safety Part
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) guidelines (Version 4.03).
Measured: Up to 16 months
Number of participants with laboratory test abnormalities in Safety Part
Number of participants with potentially clinically significant laboratory values will be reported as AEs.
Measured: Up to 14 months
Number of participants with body weight abnormalities in Safety Part
Number of participants with potentially clinically significant body weight change will be reported as AEs.
Measured: Up to 14 months
Number of participants with vital sign abnormalities in Safety Part
Number of participants with potentially clinically significant vital sign values will be reported as AEs.
Measured: Up to 14 months
Number of participants with 12-lead electrocardiogram (ECG) abnormalities in Safety Part
ECGs will be recorded with the participant in the supine position, after the subject has been lying down for approximately 5 minutes. Any clinically significant adverse changes on the ECG will be reported as AEs.
Measured: Up to 14 months
Safety assessed by Eastern Cooperative Oncology Group (ECOG) performance status in Safety Part
Number of participants with potentially clinically significant ECOG performance status values. ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead.
Measured: Up to 14 months
Objective Response Rate (ORR) by local review in Expansion Part
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Measured: Up to 13 months
Secondary outcomes (26)
ORR by local review in Safety Part
ORR is defined as the proportion of participants who have a best overall response of CR or PR per RECIST 1.1.
Measured: Up to 13 months
ORR by central review in Expansion Part
ORR is defined as the proportion of participants who have a best overall response of CR or PR per RECIST 1.1.
Measured: Up to 13 months
Disease Control Rate (DCR) in Safety Part and Expansion Part
DCR is defined as the proportion of participants who have a best overall response of CR, PR or stable disease (SD) per RECIST 1.1.
Measured: Up to 13 months
Progression Free Survival (PFS) in Safety Part and Expansion Part
PFS is defined as the time from the date of first dosing until the date of radiological or clinical progressive disease per RECIST 1.1 or death from any cause, whichever is earliest.
Measured: Up to 13 months
Overall Survival (OS) in Safety Part and Expansion Part
OS is defined as the time from the date of randomization until the date of death from any cause.
Measured: Up to 23 months
Duration of Response (DOR) in Safety Part and Expansion Part
DOR is defined as the time from the date of the first response (CR or PR) per RECIST 1.1 to the date of radiological progression or death, whichever occurs earlier.
Measured: Up to 13 months
Pharmacokinetics (PK) of IMAB362 in Safety Part and Expansion Part: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)
AUCinf will be derived from the PK serum samples collected.
Measured: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Percentage of AUCinf (AUCinf (%extrap))
AUCinf (%extrap) will be derived from the PK serum samples collected.
Measured: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: AUC from the time of dosing to the last measurable concentration (AUClast)
AUClast will be derived from the PK serum samples collected.
Measured: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: AUC from the time of dosing to the start of the next dosing interval (AUCtau)
AUCtau will be derived from the PK serum samples collected.
Measured: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Maximum concentration (Cmax)
Cmax will be derived from the PK serum samples collected.
Measured: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Concentration immediately prior to dosing at multiple dosing (Ctrough)
Ctrough will be derived from the PK serum samples collected.
Measured: Up to 16 months
PK of IMAB362 in Safety Part and Expansion Part: Time of the maximum concentration (tmax)
tmax will be derived from the PK serum samples collected.
Measured: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Terminal elimination half-life (t1/2)
t1/2 will be derived from the PK serum samples collected.
Measured: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Clearance (CL)
CL will be derived from the PK serum samples collected.
Measured: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Apparent volume of distribution at steady state (Vss)
Vss will be derived from the PK serum samples collected.
Measured: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Apparent volume of distribution during the terminal phase (Vz)
Vz will be derived from the PK serum samples collected.
Measured: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Accumulation ratio calculated using AUC (Rac(AUC))
Rac(AUC) will be derived from the PK serum samples collected.
Measured: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Rac (Cmax)
Rac(Cmax) will be derived from the PK serum samples collected.
Measured: Up to 3 months
Safety assessed by incidence of AEs in Expansion Part
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs will be graded using the CTCAE guidelines (Version 4.03).
Measured: Up to 16 months
Number of participants with laboratory test abnormalities in Expansion Part
Number of participants with potentially clinically significant laboratory values will be reported as AEs.
Measured: Up to 14 months
Number of participants with vital sign abnormalities in Expansion Part
Number of participants with potentially clinically significant vital sign values will be reported as AEs.
Measured: Up to 14 months
Number of participants with body weight abnormalities in Expansion Part
Number of participants with potentially clinically significant body weight change will be reported as AEs.
Measured: Up to 14 months
Number of participants with 12-lead ECG abnormalities in Expansion Part
ECGs will be recorded with the participant in the supine position, after the subject has been lying down for approximately 5 minutes. There should be at least 2 minutes between ECG measurements in case a repeat is needed. Any clinically significant adverse changes on the ECG will be reported as AEs.
Measured: Up to 14 months
Safety assessed by ECOG performance status in Expansion Part
Number of participants with potentially clinically significant ECOG performance status values. ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead.
Measured: Up to 14 months
Frequency of anti-drug antibody (ADA)-positive participants in Safety Part and Expansion Part
Immunogenicity of IMAB362 will be assessed by the frequency of ADA-positive participants.
Measured: Up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start8 Jun 2018
- Primary completion9 Jun 2020
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528629
- Sponsor's protocol ID
- 8951-CL-0104
- Other IDs
- jRCT2080223901
- Status last verified
- Nov 2024
- First submitted
- 6 May 2018
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Shitara K, Xu RH, Ajani JA, Moran D, Guerrero A, Li R, Pavese J, Matsangou M, Bhattacharya P, Ueno Y, Wang X, Shah MA. Global prevalence of claudin 18 isoform 2 in tumors of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Gastric Cancer. 2024 Sep;27(5):1058-1068. doi: 10.1007/s10120-024-01518-1. Epub 2024 Jul 2.
PubMed 38954176
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03528629
- Acronym / sponsor ID
- 8951-CL-0104
- Keywords
- zolbetuximab, IMAB362, pharmacokinetics, tolerability, safety, ASP8951, immunogenicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 18 May 2018 (actual)
- 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.
The purpose of this study is to assess the safety, tolerability and antitumor activity of IMAB362 in Japanese subjects with locally advanced or metastatic Gastric or GEJ adenocarcinoma whose tumors have Claudin (CLDN) 18.2 Expression. This study will also assess pharmacokinetics and immunogenicity of IMAB362.
Detailed description
This study consists of two parts (Part 1: Safety; and Part 2: Expansion). First, the subjects will be enrolled in Safety Part with IMAB362 dose-1/2 (Arm A). Then the safety and tolerability of Arm A will be evaluated at Tolerability Evaluation Meeting (TEM). If there are no safety and tolerability concerns, enrollment for the Safety Part with IMAB362 dose-3 (Arm B) and the Expansion Part with IMAB362 dose-1/2 will be opened. For each part, participants who continue to derive clinical benefit and do not have intolerable toxicity from study treatment will be allowed to remain on treatment until treatment discontinuation criterion is met.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Safety Part Arm A (IMAB362 dose-1/2) | Experimental | Drug: ZolbetuximabParticipants will receive a loading dose-1 of IMAB362 on Cycle 1 Day 1 followed by a lower dose-2 in subsequent every 3 weeks. |
| Safety Part Arm B (IMAB362 dose-3) | Experimental | Drug: ZolbetuximabParticipants will receive a loading dose-3 of IMAB362 on Day 1 of each cycle (every 3 weeks). |
| Expansion Part (IMAB362 dose-1/2) | Experimental | Drug: ZolbetuximabParticipants will receive a loading dose-1 of IMAB362 on Cycle 1 Day 1 followed by a lower dose-2 in subsequent every 3 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject has histologically or cytologically confirmed diagnosis of gastric or gastro-esophageal junction adenocarcinoma.
- Subject has gastric or gastroesophageal junction (GEJ) adenocarcinoma based on radiographic imaging or endoscopic examination.
- Subject agrees not to participate in another interventional study while on treatment.
- Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Subject has predicted life expectancy ≥ 12 weeks.
Key exclusion criteria (19 listed)
- Subject has prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies.
- Subject has had radiotherapy within 2 weeks prior to first dose of study drug. Subject who received palliative radiotherapy to peripheral bone metastases within 2 weeks prior to first dose of study drug and has recovered from all acute toxicities is allowed.
- Subject has received other investigational agents or devices concurrently or within 4 weeks prior first dose of study drug.
- Subject has received systemic immunosuppressive therapy, including systemic corticosteroids 2 weeks prior to first dose of study drug. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent are allowed.
- Subject has gastric outlet syndrome or persistent recurrent vomiting.
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 |
|---|---|---|
| ZolbetuximabAlso: IMAB362Zolbetuximab will be administered as a 2-hour intravenous infusion. | Drug | Expansion Part (IMAB362 dose-1/2), Safety Part Arm A (IMAB362 dose-1/2), Safety Part Arm B (IMAB362 dose-3) |
Primary outcome
Dose Limiting Toxicities (DLT) in Safety Part
Time frame: Up to Day 22
Any of the IMAB362 related AEs specified as the DLTs will be assessed during the first 3 weeks.
Safety and tolerability assessed by incidence of adverse events (AEs) in Safety Part
Time frame: Up to 16 months
An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) guidelines (Version 4.03).
Number of participants with laboratory test abnormalities in Safety Part
Time frame: Up to 14 months
Number of participants with potentially clinically significant laboratory values will be reported as AEs.
Number of participants with body weight abnormalities in Safety Part
Time frame: Up to 14 months
Number of participants with potentially clinically significant body weight change will be reported as AEs.
Number of participants with vital sign abnormalities in Safety Part
Time frame: Up to 14 months
Number of participants with potentially clinically significant vital sign values will be reported as AEs.
Number of participants with 12-lead electrocardiogram (ECG) abnormalities in Safety Part
Time frame: Up to 14 months
ECGs will be recorded with the participant in the supine position, after the subject has been lying down for approximately 5 minutes. Any clinically significant adverse changes on the ECG will be reported as AEs.
Safety assessed by Eastern Cooperative Oncology Group (ECOG) performance status in Safety Part
Time frame: Up to 14 months
Number of participants with potentially clinically significant ECOG performance status values. ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead.
Objective Response Rate (ORR) by local review in Expansion Part
Time frame: Up to 13 months
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
26 secondary outcomes
ORR by local review in Safety Part
Time frame: Up to 13 months
ORR by central review in Expansion Part
Time frame: Up to 13 months
Disease Control Rate (DCR) in Safety Part and Expansion Part
Time frame: Up to 13 months
Progression Free Survival (PFS) in Safety Part and Expansion Part
Time frame: Up to 13 months
Overall Survival (OS) in Safety Part and Expansion Part
Time frame: Up to 23 months
Duration of Response (DOR) in Safety Part and Expansion Part
Time frame: Up to 13 months
Pharmacokinetics (PK) of IMAB362 in Safety Part and Expansion Part: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)
Time frame: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Percentage of AUCinf (AUCinf (%extrap))
Time frame: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: AUC from the time of dosing to the last measurable concentration (AUClast)
Time frame: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: AUC from the time of dosing to the start of the next dosing interval (AUCtau)
Time frame: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Maximum concentration (Cmax)
Time frame: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Concentration immediately prior to dosing at multiple dosing (Ctrough)
Time frame: Up to 16 months
PK of IMAB362 in Safety Part and Expansion Part: Time of the maximum concentration (tmax)
Time frame: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Terminal elimination half-life (t1/2)
Time frame: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Clearance (CL)
Time frame: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Apparent volume of distribution at steady state (Vss)
Time frame: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Apparent volume of distribution during the terminal phase (Vz)
Time frame: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Accumulation ratio calculated using AUC (Rac(AUC))
Time frame: Up to 3 months
PK of IMAB362 in Safety Part and Expansion Part: Rac (Cmax)
Time frame: Up to 3 months
Safety assessed by incidence of AEs in Expansion Part
Time frame: Up to 16 months
Number of participants with laboratory test abnormalities in Expansion Part
Time frame: Up to 14 months
Number of participants with vital sign abnormalities in Expansion Part
Time frame: Up to 14 months
Number of participants with body weight abnormalities in Expansion Part
Time frame: Up to 14 months
Number of participants with 12-lead ECG abnormalities in Expansion Part
Time frame: Up to 14 months
Safety assessed by ECOG performance status in Expansion Part
Time frame: Up to 14 months
Frequency of anti-drug antibody (ADA)-positive participants in Safety Part and Expansion Part
Time frame: Up to 16 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 2 Dec 2024.
- Derived from this study: PubMed 38954176Shitara K, Xu RH, Ajani JA, Moran D, Guerrero A, Li R, Pavese J, Matsangou M, Bhattacharya P, Ueno Y, Wang X, Shah MA. Global prevalence of claudin 18 isoform 2 in tumors of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Gastric Cancer. 2024 Sep;27(5):1058-1068. doi: 10.1007/s10120-024-01518-1. Epub 2024 Jul 2.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Medical Director study director
Astellas Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zolbetuximab in people with Gastric Cancer and Gastro-esophageal Junction (GEJ) Cancer, run by Astellas Pharma Inc at 1 site in Japan.
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 12 inclusion and 19 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 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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.
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 Limiting Toxicities (DLT) in Safety Part (time frame: Up to Day 22). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03528629, which also lists 1 linked publication.
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 2 Dec 2024.