JOURNAL ONKOLOGIE – STUDIE
Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma
Rekrutierend
NCT-Nummer:
NCT04260191
Studienbeginn:
Juni 2020
Letztes Update:
29.12.2020
Wirkstoff:
AMG 910
Indikation (Clinical Trials):
Adenocarcinoma, Esophageal Neoplasms
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 1
Sponsor:
Amgen
Collaborator:
-
Studienleiter
Study Director
Amgen
Kontakt
Kontakt:
Phone: 866-572-6436
E-Mail: medinfo@amgen.com» Kontaktdaten anzeigen
Studienlocations (3 von 16)
Research Site
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-MapsResearch Site
04103 Leipzig
(Sachsen)
GermanyRekrutierend» Google-MapsResearch Site
81377 München
(Bayern)
GermanyRekrutierend» Google-Maps
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-MapsResearch Site
04103 Leipzig
(Sachsen)
GermanyRekrutierend» Google-MapsResearch Site
81377 München
(Bayern)
GermanyRekrutierend» Google-Maps
Research Site
81675 München
(Bayern)
GermanyRekrutierend» Google-MapsResearch Site
91010 Duarte
United StatesRekrutierend» Google-MapsResearch Site
92868 Orange
United StatesRekrutierend» Google-MapsResearch Site
27157 Winston-Salem
United StatesRekrutierend» Google-MapsResearch Site
05020 Salzburg
AustriaRekrutierend» Google-MapsResearch Site
464-8681 Nagoya-shi
JapanRekrutierend» Google-MapsResearch Site
277-8577 Kashiwa-shi
JapanRekrutierend» Google-MapsResearch Site
104-0045 Chuo-ku
JapanRekrutierend» Google-MapsResearch Site
03722 Seoul
Korea, Republic ofRekrutierend» Google-MapsResearch Site
06351 Seoul
Korea, Republic ofRekrutierend» Google-MapsResearch Site
110-744 Seoul
Korea, Republic ofRekrutierend» Google-MapsResearch Site
138-736 Seoul
Korea, Republic ofRekrutierend» Google-MapsResearch Site
08035 Barcelona
SpainRekrutierend» Google-Maps
Alle anzeigen 81675 München
(Bayern)
GermanyRekrutierend» Google-MapsResearch Site
91010 Duarte
United StatesRekrutierend» Google-MapsResearch Site
92868 Orange
United StatesRekrutierend» Google-MapsResearch Site
27157 Winston-Salem
United StatesRekrutierend» Google-MapsResearch Site
05020 Salzburg
AustriaRekrutierend» Google-MapsResearch Site
464-8681 Nagoya-shi
JapanRekrutierend» Google-MapsResearch Site
277-8577 Kashiwa-shi
JapanRekrutierend» Google-MapsResearch Site
104-0045 Chuo-ku
JapanRekrutierend» Google-MapsResearch Site
03722 Seoul
Korea, Republic ofRekrutierend» Google-MapsResearch Site
06351 Seoul
Korea, Republic ofRekrutierend» Google-MapsResearch Site
110-744 Seoul
Korea, Republic ofRekrutierend» Google-MapsResearch Site
138-736 Seoul
Korea, Republic ofRekrutierend» Google-MapsResearch Site
08035 Barcelona
SpainRekrutierend» Google-Maps
Studien-Informationen
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)
Ein-/Ausschlusskriterien
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.
Exclusion Criteria:
- Any anticancer therapy or immunotherapy within 4 weeks of start of first dose.
- 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.
Studien-Rationale
Primary outcome: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:
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)
Studien-Arme
- 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. - 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.
Geprüfte Regime
- AMG 910:
Dose Exploration Dose Expansion
Quelle: ClinicalTrials.gov