A Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-eso… (NCT03528629) | Clinical Trial Compass
CompletedNot Applicable
A Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
Japan18 participantsStarted 2018-06-08
Plain-language 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.
Who can participate
Age range20 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* 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…
What they're measuring
1
Dose Limiting Toxicities (DLT) in Safety Part
Timeframe: Up to Day 22
2
Safety and tolerability assessed by incidence of adverse events (AEs) in Safety Part
Timeframe: Up to 16 months
3
Number of participants with laboratory test abnormalities in Safety Part
Timeframe: Up to 14 months
4
Number of participants with body weight abnormalities in Safety Part
Timeframe: Up to 14 months
5
Number of participants with vital sign abnormalities in Safety Part
Timeframe: Up to 14 months
6
Number of participants with 12-lead electrocardiogram (ECG) abnormalities in Safety Part
Timeframe: Up to 14 months
7
Safety assessed by Eastern Cooperative Oncology Group (ECOG) performance status in Safety Part
Timeframe: Up to 14 months
8
Objective Response Rate (ORR) by local review in Expansion Part