Clinical Trials List
Protocol Number20180292
NCT Number(ClinicalTrials.gov Identfier)NCT04260191
2021-04-01 - 2023-01-31
Phase I
Not yet recruiting1
Terminated1
ICD-10C16.9
Malignant neoplasm of stomach, unspecified
A Global Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of the Half-life Extended Bispecific T-cell Engager AMG 910 in Subjects With Claudin 18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Amgen Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Ming-Huang Chen Division of Hematology & Oncology
- Shao-Jung Hsu Division of General Internal Medicine
- Rheun-Chuan Lee Division of Radiology
- Yun-Cheng Hsieh Division of General Internal Medicine
- Chung-Pin Li Division of Hematology & Oncology
- Yi-Ping Hung Division of Hematology & Oncology
- San-Chi Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Chih-Hung Hsu Division of Hematology & Oncology
- 陳國興 Division of Hematology & Oncology
- Chiun Hsu Division of Hematology & Oncology
- Kun-Huei Yeh Division of Hematology & Oncology
- Hsiang-Fong Kao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Claudin 18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma
Objectives
To evaluate the safety and tolerability of AMG 910 in adult subjects, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
Test Drug
AMG910
Active Ingredient
AMG910
Dosage Form
Powder for solution for infusion
Dosage
1
Endpoints
Primary Outcome Measures :
Number of participants with dose-limiting toxicities (DLT) [ Time Frame: 2 years ]
Subject grade of dose limiting toxicities is the occurrence of any of the toxicities during the DLT evaluation period if judged by the investigator to be related to the administration of AMG 910
Number of participants with treatment-emergent adverse events [ Time Frame: 2 years ]
Number of participants with treatment-related adverse events [ Time Frame: 2 years ]
Number of participants with clinically significant changes in vital signs [ Time Frame: 2 years ]
Number of participants with clinically significant changes in electrocardiogram (ECG) [ Time Frame: 2 years ]
Number of participants with clinically significant changes in clinical laboratory tests [ Time Frame: 2 years ]
Secondary Outcome Measures :
Maximum serum concentration (Cmax) [ Time Frame: 2 years ]
Minimum serum concentration (Cmin) [ Time Frame: 2 years ]
Area under the concentration-time curve (AUC) over the dosing interval [ Time Frame: 2 years ]
AUC accumulation following multiple dosing [ Time Frame: 2 years ]
Half-life (t1/2) [ Time Frame: 2 years ]
Objective response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST [ Time Frame: 2 years ]
Duration of response (DOR) [ Time Frame: 2 years ]
Time to progression [ Time Frame: 2 years ]
Progression-free survival (PFS) [ Time Frame: 6 months and 1 year ]
Overall survival (OS) [ Time Frame: 1 year and 2 years ]
Number of participants with dose-limiting toxicities (DLT) [ Time Frame: 2 years ]
Subject grade of dose limiting toxicities is the occurrence of any of the toxicities during the DLT evaluation period if judged by the investigator to be related to the administration of AMG 910
Number of participants with treatment-emergent adverse events [ Time Frame: 2 years ]
Number of participants with treatment-related adverse events [ Time Frame: 2 years ]
Number of participants with clinically significant changes in vital signs [ Time Frame: 2 years ]
Number of participants with clinically significant changes in electrocardiogram (ECG) [ Time Frame: 2 years ]
Number of participants with clinically significant changes in clinical laboratory tests [ Time Frame: 2 years ]
Secondary Outcome Measures :
Maximum serum concentration (Cmax) [ Time Frame: 2 years ]
Minimum serum concentration (Cmin) [ Time Frame: 2 years ]
Area under the concentration-time curve (AUC) over the dosing interval [ Time Frame: 2 years ]
AUC accumulation following multiple dosing [ Time Frame: 2 years ]
Half-life (t1/2) [ Time Frame: 2 years ]
Objective response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST [ Time Frame: 2 years ]
Duration of response (DOR) [ Time Frame: 2 years ]
Time to progression [ Time Frame: 2 years ]
Progression-free survival (PFS) [ Time Frame: 6 months and 1 year ]
Overall survival (OS) [ Time Frame: 1 year and 2 years ]
Inclution Criteria
Inclusion Criteria:
Subjects with histologically or cytologically confirmed metastatic or locally advanced unresectable gastric or GEJ adenocarcinoma positive for CLDN18.2.
Subjects should not be eligible for curative surgery and should have been refractory to or have relapsed after two or more prior lines of standard systemic therapy that included a platinum, a fluoropyrimidine, either a taxane or irinotecan, and an approved vascular endothelial growth factor receptor (VEGFR) antibody/tyrosine kinase inhibitor (TKI) and depending on country-specific standards and approvals.
For subjects eligible for human epidermal growth factor receptor 2 (HER2) directed therapy, prior systemic therapy should have included a HER2 targeting antibody approved for treatment of gastric cancer.
Subjects may also be included if the aforementioned therapeutic options were medically not appropriate for them. In these cases, the reason(s) why required prior therapies for gastric cancer were medically not appropriate should be documented in the subject's electronic case report form (eCRF).
For dose-expansion only: Subjects with at least 1 measurable lesion greater than or equal to 10mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study.
Subjects with stable condition and anti-coagulative therapy ongoing for at least 1 month, no obvious signs and symptoms of bleeding, and coagulation parameters are fulfilled.
Subjects should be able to use proton pump inhibitors.
Subjects with histologically or cytologically confirmed metastatic or locally advanced unresectable gastric or GEJ adenocarcinoma positive for CLDN18.2.
Subjects should not be eligible for curative surgery and should have been refractory to or have relapsed after two or more prior lines of standard systemic therapy that included a platinum, a fluoropyrimidine, either a taxane or irinotecan, and an approved vascular endothelial growth factor receptor (VEGFR) antibody/tyrosine kinase inhibitor (TKI) and depending on country-specific standards and approvals.
For subjects eligible for human epidermal growth factor receptor 2 (HER2) directed therapy, prior systemic therapy should have included a HER2 targeting antibody approved for treatment of gastric cancer.
Subjects may also be included if the aforementioned therapeutic options were medically not appropriate for them. In these cases, the reason(s) why required prior therapies for gastric cancer were medically not appropriate should be documented in the subject's electronic case report form (eCRF).
For dose-expansion only: Subjects with at least 1 measurable lesion greater than or equal to 10mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study.
Subjects with stable condition and anti-coagulative therapy ongoing for at least 1 month, no obvious signs and symptoms of bleeding, and coagulation parameters are fulfilled.
Subjects should be able to use proton pump inhibitors.
Exclusion Criteria
Exclusion Criteria:
Any anticancer therapy or immunotherapy within 4 weeks of start of first dose (14 days for palliative radiation).
Untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy while on study, eg, ulcerative colitis, Crohn's disease, or any other gastrointestinal autoimmune disorder causing chronic nausea, vomiting, or diarrhea. Recent or current use of inhaled steroids or physiological substitution in case of adrenal insufficiency is not exclusionary.
Evidence or history within last 3 months of gastrointestinal inflammatory conditions not associated with the underlying cancer disease including gastrinomas, duodenitis, proven gastric ulcer, duodenal ulcer, pancreatitis, or subjects with recent gastric bleeding. Subjects may be included if the symptomatic/immunosuppressive treatment is discontinued more than 4 weeks prior to the first dose of AMG 910, symptoms have resolved, and gastroscopy does not indicate signs of active disease.
Subjects with inherited bleeding disorders (eg, Willebrand's disease, hemophilia A and other clotting factor deficiency) and subjects with known heparin-induced thrombocytopenia.
Subjects requiring non-steroidal anti-inflammatory drugs (NSAIDs) during study treatment. The NSAID(s) should be stopped within 7 days prior to start of treatment.
Any anticancer therapy or immunotherapy within 4 weeks of start of first dose (14 days for palliative radiation).
Untreated or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy while on study, eg, ulcerative colitis, Crohn's disease, or any other gastrointestinal autoimmune disorder causing chronic nausea, vomiting, or diarrhea. Recent or current use of inhaled steroids or physiological substitution in case of adrenal insufficiency is not exclusionary.
Evidence or history within last 3 months of gastrointestinal inflammatory conditions not associated with the underlying cancer disease including gastrinomas, duodenitis, proven gastric ulcer, duodenal ulcer, pancreatitis, or subjects with recent gastric bleeding. Subjects may be included if the symptomatic/immunosuppressive treatment is discontinued more than 4 weeks prior to the first dose of AMG 910, symptoms have resolved, and gastroscopy does not indicate signs of active disease.
Subjects with inherited bleeding disorders (eg, Willebrand's disease, hemophilia A and other clotting factor deficiency) and subjects with known heparin-induced thrombocytopenia.
Subjects requiring non-steroidal anti-inflammatory drugs (NSAIDs) during study treatment. The NSAID(s) should be stopped within 7 days prior to start of treatment.
The Estimated Number of Participants
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Taiwan
6 participants
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Global
70 participants
