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Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT04260191
Recruitment Status : Recruiting
First Posted : February 7, 2020
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Gastric and Gastroesophageal Junction Adenocarcinoma Drug: AMG 910 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 29, 2020
Estimated Primary Completion Date : October 26, 2025
Estimated Study Completion Date : October 26, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose-exploration
The dose-exploration phase of the study will estimate the MTD (Maximum Tolerated Dose) of AMG 910 using a Bayesian logistic regression model (BLRM). A RP2D (Recommended Phase 2 Dose) may be identified based on emerging safety, efficacy, and PD (Pharmacodynamics) data prior to reaching an MTD. Alternative dosing schedule(s) may be explored based on emerging PK (Pharmacokinetics) and safety data.
Drug: AMG 910
Dose Exploration Dose Expansion

Experimental: Dose-expansion
The dose-expansion phase will be conducted to confirm safety, PK, and PD at the MTD or RP2D and to obtain further safety and efficacy data and enable correlative biomarker analysis.
Drug: AMG 910
Dose Exploration Dose Expansion




Primary Outcome Measures :
  1. 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

  2. Number of participants with treatment-emergent adverse events [ Time Frame: 2 years ]
  3. Number of participants with treatment-related adverse events [ Time Frame: 2 years ]
  4. Number of participants with clinically significant changes in vital signs [ Time Frame: 2 years ]
  5. Number of participants with clinically significant changes in electrocardiogram (ECG) [ Time Frame: 2 years ]
  6. Number of participants with clinically significant changes in clinical laboratory tests [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Maximum serum concentration (Cmax) [ Time Frame: 2 years ]
  2. Minimum serum concentration (Cmin) [ Time Frame: 2 years ]
  3. Area under the concentration-time curve (AUC) over the dosing interval [ Time Frame: 2 years ]
  4. AUC accumulation following multiple dosing [ Time Frame: 2 years ]
  5. Half-life (t1/2) [ Time Frame: 2 years ]
  6. Objective response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST [ Time Frame: 2 years ]
  7. Duration of response (DOR) [ Time Frame: 2 years ]
  8. Time to progression [ Time Frame: 2 years ]
  9. Progression-free survival (PFS) [ Time Frame: 6 months and 1 year ]
  10. Overall survival (OS) [ Time Frame: 1 year and 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  • 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:

  • Any anticancer therapy or immunotherapy within 4 weeks of start of first dose (14 weeks 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04260191


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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United States, California
Research Site Recruiting
Duarte, California, United States, 91010
Research Site Recruiting
Orange, California, United States, 92868
United States, North Carolina
Research Site Recruiting
Winston-Salem, North Carolina, United States, 27157
Austria
Research Site Recruiting
Salzburg, Austria, 5020
France
Research Site Recruiting
Villejuif, France, 94805
Germany
Research Site Recruiting
Hamburg, Germany, 20246
Research Site Recruiting
Leipzig, Germany, 04103
Research Site Recruiting
München, Germany, 81377
Research Site Recruiting
München, Germany, 81675
Japan
Research Site Recruiting
Nagoya-shi, Aichi, Japan, 464-8681
Research Site Recruiting
Kashiwa-shi, Chiba, Japan, 277-8577
Research Site Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Korea, Republic of
Research Site Recruiting
Seoul, Korea, Republic of, 03722
Research Site Recruiting
Seoul, Korea, Republic of, 05505
Research Site Recruiting
Seoul, Korea, Republic of, 06351
Research Site Recruiting
Seoul, Korea, Republic of, 110-744
Spain
Research Site Recruiting
Barcelona, Cataluña, Spain, 08035
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04260191    
Other Study ID Numbers: 20180292
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purposeof re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases