Gastric or Gastro-esophageal Junction (GEJ) AdenocarcinomaPhase 1NCT04086758
A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
A Phase 1 study testing zolbetuximab in people with Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma, run by Astellas Pharma China, Inc. at 1 site in China.
Trial summary
A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects with Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
- 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
- 12 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2019to 22 Jan 2021
- 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
- Subject has histologically confirmed diagnosis of gastric or gastro-esophageal junction (GEJ) adenocarcinoma, with radiologically confirmed locally advanced unresectable or metastatic disease, who has no standard of care treatment option or subject is ineligible to receive available standard of care treatment option (any line of treatment).
- Subject agrees not to use another investigational product or medical device while on treatment.
- A female subject is eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin (βhCG) and a demonstrated non-pregnant status through additional testing are eligible) and at least 1 of the following conditions applies:
- Not a woman of childbearing potential (WOCBP), OR
- WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 6 months after the final study drug administration.
- Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 6 months after the final study drug administration.
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- Female subject must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.
- A sexually active male subject with female partner(s) who are not of childbearing potential is eligible if:
- Agree to use a male condom starting at screening and continue throughout study treatment and for 6 months after the final study drug administration.
- A sexually active male subject with female partner(s) who are of childbearing potential must agree to use contraception during the treatment and for at least 6-months after the final study drug administration.
- Male subject must not donate sperm starting at Screening, throughout the study period and for 6 months after the final study drug administration.
- Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding from the start of screening to 6 months after the final study drug administration.
- 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.
- Subject must meet all of the following criteria on the laboratory tests that will be analyzed locally within 14 days prior to the first dose of study drug. In case of multiple laboratory data within this period, the most recent data should be used.
- Hemoglobin (Hgb) ≥ 9 g/dL (no transfusion within 7 days of start of study treatment)
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
- Platelets ≥ 100 × 10^9/L
- Albumin ≥ 2.5 g/dL
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN without liver metastases (≤ 5 x ULN if liver metastases are present)
- Estimated creatinine clearance ≥ 30 mL/min
- Prothrombin time/international normalized ratio and partial thromboplastin time ≤ 1.5 × ULN (except for patients receiving anticoagulation therapy)
- Subject's tumor sample has Claudin (CLDN) 18.2 membranous staining in tumor cells with any intensity (≥ 1) as determined by central Immunohistochemistry (IHC) testing.
Who cannot join
- Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies like zolbetuximab.
- Subject has received another investigational product or medical device concurrently or within 4 weeks prior first dose of study drug.
- Subject has had radiotherapy within 2 weeks prior to first dose of study treatment. Subject who received palliative radiotherapy to peripheral bone metastases within 2 weeks prior to first dose of study treatment and has recovered from all acute toxicities is allowed.
- 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 (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone) or a single dose of systemic corticosteroid are allowed.
- Subject has gastric outlet obstruction or persistent recurrent vomiting.
- Subject has uncontrolled or significant gastrointestinal hemorrhage.
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- 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, an HB 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 ≤ 28 days prior to the first dose of study drug.
- Subject has not completely recovered from a major surgical procedure ≤ 14 days prior to the first dose of study treatment.
- 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 Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects with Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
- Being tested
- zolbetuximab
- Keywords
- Pharmacokinetic, MDV3100, zolbetuximab
- Medical subject headings
- Adenocarcinoma
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 |
|---|---|---|
| Zolbetuximab | Experimental | Participants will receive a loading dose-1 of zolbetuximab on Day 1 of Cycle 1, consists of 21 days, followed by subsequent lower dose-2 every 3 weeks until they meet the discontinuation criteria. Receives: Drug: zolbetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of zolbetuximab: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)
AUCinf will be recorded from the PK serum samples collected.
Measured: Up to 15 months
PK of zolbetuximab: Percentage of AUCinf (AUCinf (%extrap))
AUCinf (%extrap) will be recorded from the PK serum samples collected.
Measured: Up to 15 months
PK of zolbetuximab: AUC from the time of dosing to the last measurable concentration (AUClast)
AUClast will be recorded from the PK serum samples collected.
Measured: Up to 15 months
PK of zolbetuximab: AUC from the time of dosing to the start of the next dosing interval (AUCtau)
AUCtau will be recorded d from the PK serum samples collected.
Measured: Up to 15 months
PK of zolbetuximab: Maximum concertation (Cmax)
Cmax will be recorded from the PK serum samples collected.
Measured: Up to 15 months
PK of zolbetuximab: Concentration immediately prior to dosing at multiple dosing (Ctrough)
Ctrough will be recorded from the PK serum samples collected.
Measured: Up to 15 months
PK of zolbetuximab: Time of the maximum concentration (tmax)
tmax will be recorded from the PK serum samples collected.
Measured: Up to 15 months
PK of zolbetuximab: Terminal elimination half-life (t1/2)
t1/2 will be recorded from the PK serum samples collected.
Measured: Up to 15 months
PK of zolbetuximab: Time of the last measurable concentration (tlast)
tlast will be recorded from the PK serum samples collected.
Measured: Up to 15 months
PK of zolbetuximab: Clearance (CL)
CL will be recorded from the PK serum samples collected.
Measured: Up to 15 months
PK of zolbetuximab: Apparent volume of distribution during the terminal phase (Vz)
Vz will be recorded from the PK serum samples collected.
Measured: Up to 15 months
PK of zolbetuximab: Accumulation ratio calculated using AUC (Rac(AUC))
Rac(AUC) will be recorded from the PK serum samples collected.
Measured: Up to 15 months
PK of zolbetuximab: Rac (Cmax)
Rac(Cmax)will be recorded from the PK serum samples collected.
Measured: Up to 15 months
Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. AE is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event. Treatment Emergent Adverse Event (TEAE) is defined as an adverse event observed after starting administration of the study drug and within 30 days after the last dose of study drug.
Measured: Up to 15 months
Number of participants with laboratory test abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Measured: Up to 13 months
Number of participants with body weight abnormalities and/or AEs
Number of participants with potentially clinically significant body weight changes.
Measured: Up to 13 months
Number of participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Measured: Up to 13 months
Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant 12-ECG values.
Measured: Up to 13 months
Eastern Cooperative Oncology Group (ECOG) performance status score
ECOG performance status will be assessed on the following 6-point scale; 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 housework, 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; 5=Dead. Decrease in the score indicates an improvement. Increase in the score indicates a decline in performance.
Measured: Up to 13 months
Secondary outcomes (6)
Proportion of anti-drug antibody (ADA) positive participants
Proportion of participants with presence of ADA will be assessed.
Measured: Up to 15 months
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects whose best overall response (BOR) is rated as compete response (CR) or partial response (PR) among all analyzed subjects. Complete response (CR) of target lesions is defined as disappearance of all target lesions. Any pathological lymph nodes, if chosen as target lesions, must have a reduction in the short axis to < 10 mm from the baseline measurement. Partial response (PR) of target lesions is defined as at least a 30% decrease in the sum of diameters of target lesions (long diameter for non-pathological lymph nodes and short diameter for pathological lymph nodes), taking the baseline sum diameter as a reference. BOR rated as CR or PR should be confirmed by at least 2 consecutive assessments performed at a minimum interval of 4 weeks. Subjects must therefore meet the criteria for CR or PR continuously for 4 weeks or longer.
Measured: Up to 12 months
Duration of Progression Free Survival (PFS)
PFS is defined as the time from the start of study treatment until death from any cause, or radiographic or clinical disease progression per RECIST 1.1, whichever occurs earlier.
Measured: Up to 12 months
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects whose BOR is rated as CR, PR, or stable disease (SD) among all analyzed subjects. SD of target lesions is defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for progressive disease (PD), taking the smallest sum diameter on study as a reference. (PD) of the target lesions is defined as at least a 20% increase in the sum of the diameters of target lesions (long diameter for non-pathological lymph nodes and short diameter for pathological lymph nodes), taking the smallest sum on study (this includes the baseline sum if that is the smallest on study) as a reference. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Measured: Up to 12 months
Duration of Response (DOR)
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 PD, clinical progression only if radiological assessment is not available, or death, whichever occurs earlier.
Measured: Up to 12 months
Duration of Overall Survival (OS)
OS is defined as the time from the date of randomization until the date of death from any cause.
Measured: Up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start18 Oct 2019
- Primary completion22 Jan 2021
- Study completion22 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric or Gastro-esophageal Junction (GEJ) AdenocarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma China, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Science Manager, Study director, Astellas Pharma China, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086758
- Sponsor's protocol ID
- 8951-CL-0105
- Status last verified
- Nov 2024
- First submitted
- 10 Sep 2019
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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/.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04086758
- Acronym / sponsor ID
- 8951-CL-0105
- Keywords
- Pharmacokinetic, MDV3100, zolbetuximab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Astellas Pharma China, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 12 Sep 2019 (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.
A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects with Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zolbetuximab | Experimental | Drug: zolbetuximabParticipants will receive a loading dose-1 of zolbetuximab on Day 1 of Cycle 1, consists of 21 days, followed by subsequent lower dose-2 every 3 weeks until they meet the discontinuation criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Subject has histologically confirmed diagnosis of gastric or gastro-esophageal junction (GEJ) adenocarcinoma, with radiologically confirmed locally advanced unresectable or metastatic disease, who has no standard of care treatment option or subject is ineligible to receive available standard of care treatment option (any line of treatment).
- Subject agrees not to use another investigational product or medical device while on treatment.
- A female subject is eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin (βhCG) and a demonstrated non-pregnant status through additional testing are eligible) and at least 1 of the following conditions applies:
- Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 6 months after the final study drug administration.
- Female subject must not donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.
Key exclusion criteria (20 listed)
- Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies like zolbetuximab.
- Subject has received another investigational product or medical device concurrently or within 4 weeks prior first dose of study drug.
- Subject has had radiotherapy within 2 weeks prior to first dose of study treatment. Subject who received palliative radiotherapy to peripheral bone metastases within 2 weeks prior to first dose of study treatment and has recovered from all acute toxicities is allowed.
- 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 (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone) or a single dose of systemic corticosteroid are allowed.
- Subject has gastric outlet obstruction 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 | Zolbetuximab |
Primary outcome
Pharmacokinetics (PK) of zolbetuximab: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)
Time frame: Up to 15 months
AUCinf will be recorded from the PK serum samples collected.
PK of zolbetuximab: Percentage of AUCinf (AUCinf (%extrap))
Time frame: Up to 15 months
AUCinf (%extrap) will be recorded from the PK serum samples collected.
PK of zolbetuximab: AUC from the time of dosing to the last measurable concentration (AUClast)
Time frame: Up to 15 months
AUClast will be recorded from the PK serum samples collected.
PK of zolbetuximab: AUC from the time of dosing to the start of the next dosing interval (AUCtau)
Time frame: Up to 15 months
AUCtau will be recorded d from the PK serum samples collected.
PK of zolbetuximab: Maximum concertation (Cmax)
Time frame: Up to 15 months
Cmax will be recorded from the PK serum samples collected.
PK of zolbetuximab: Concentration immediately prior to dosing at multiple dosing (Ctrough)
Time frame: Up to 15 months
Ctrough will be recorded from the PK serum samples collected.
PK of zolbetuximab: Time of the maximum concentration (tmax)
Time frame: Up to 15 months
tmax will be recorded from the PK serum samples collected.
PK of zolbetuximab: Terminal elimination half-life (t1/2)
Time frame: Up to 15 months
t1/2 will be recorded from the PK serum samples collected.
PK of zolbetuximab: Time of the last measurable concentration (tlast)
Time frame: Up to 15 months
tlast will be recorded from the PK serum samples collected.
PK of zolbetuximab: Clearance (CL)
Time frame: Up to 15 months
CL will be recorded from the PK serum samples collected.
PK of zolbetuximab: Apparent volume of distribution during the terminal phase (Vz)
Time frame: Up to 15 months
Vz will be recorded from the PK serum samples collected.
PK of zolbetuximab: Accumulation ratio calculated using AUC (Rac(AUC))
Time frame: Up to 15 months
Rac(AUC) will be recorded from the PK serum samples collected.
PK of zolbetuximab: Rac (Cmax)
Time frame: Up to 15 months
Rac(Cmax)will be recorded from the PK serum samples collected.
Number of participants with adverse events (AEs)
Time frame: Up to 15 months
An AE is any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. AE is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event. Treatment Emergent Adverse Event (TEAE) is defined as an adverse event observed after starting administration of the study drug and within 30 days after the last dose of study drug.
Number of participants with laboratory test abnormalities and/or AEs
Time frame: Up to 13 months
Number of participants with potentially clinically significant laboratory values.
Number of participants with body weight abnormalities and/or AEs
Time frame: Up to 13 months
Number of participants with potentially clinically significant body weight changes.
Number of participants with vital sign abnormalities and/or AEs
Time frame: Up to 13 months
Number of participants with potentially clinically significant vital sign values.
Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs
Time frame: Up to 13 months
Number of participants with potentially clinically significant 12-ECG values.
Eastern Cooperative Oncology Group (ECOG) performance status score
Time frame: Up to 13 months
ECOG performance status will be assessed on the following 6-point scale; 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 housework, 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; 5=Dead. Decrease in the score indicates an improvement. Increase in the score indicates a decline in performance.
6 secondary outcomes
Proportion of anti-drug antibody (ADA) positive participants
Time frame: Up to 15 months
Objective Response Rate (ORR)
Time frame: Up to 12 months
Duration of Progression Free Survival (PFS)
Time frame: Up to 12 months
Disease Control Rate (DCR)
Time frame: Up to 12 months
Duration of Response (DOR)
Time frame: Up to 12 months
Duration of Overall Survival (OS)
Time frame: Up to 15 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 20 Nov 2024.
- Link to results and other applicable study documents on the Astellas Clinical Trials websiteLink provided by the sponsor.
- Link to plain language summary of the study on the Trial Results Summaries websiteLink provided by the sponsor.
- 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 Science Manager study director
Astellas Pharma China, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing zolbetuximab in people with Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma, run by Astellas Pharma China, Inc. at 1 site in China.
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 25 inclusion and 20 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 20 Nov 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 China. 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?
Pharmacokinetics (PK) of zolbetuximab: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf) (time frame: Up to 15 months). The study lists 19 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 20 Nov 2024.