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JOURNAL ONKOLOGIE – STUDIE

Study of AMG 199 in Subjects With MUC17-Positive Gastric and Gastroesophageal Junction Cancer

Rekrutierend

NCT-Nummer:
NCT04117958

Studienbeginn:
Januar 2020

Letztes Update:
03.06.2021

Wirkstoff:
AMG 199

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Amgen

Collaborator:
-

Studienleiter

MD
Study Director
Amgen

Kontakt

Studienlocations
(3 von 18)

Universitaetsklinikum Hamburg Eppendorf Onkologisches Zentrum
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Gynäkologisches Tumorzentrum am Universitätsklinikum Leipzig
4103 Leipzig
DeutschlandRekrutierend» Google-Maps
Darmkrebszentrum am Klinikum der Universität München Campus Großhadern
Marchioninistraße 15
81377 München
DeutschlandRekrutierend» Google-Maps
Pankreaskrebszentrum am Klinikum rechts der Isar
Ismaninger Straße 22
81675 München
DeutschlandRekrutierend» Google-Maps
City of Hope National Medical Center
91010 Duarte
United StatesRekrutierend» Google-Maps
University of California at Irvine Medical Center
92868 Orange
United StatesRekrutierend» Google-Maps
Wake Forest Baptist Health
27157 Winston-Salem
United StatesRekrutierend» Google-Maps
Aichi Cancer Center Hospital
464-8681 Nagoya-shi
JapanRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Kashiwa-shi
JapanRekrutierend» Google-Maps
National Cancer Center Hospital
104-0045 Chuo-ku
JapanRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital Yonsei University Health System
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
138-736 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Amsterdam UMC - location VUmc
1105 AZ Amsterdam
NetherlandsRekrutierend» Google-Maps
Hospital Universitari Vall d Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia
46010 Valencia
SpainRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

AMG 199 is a novel half-life extended (HLE) bispecific T cell engager (BiTE®) molecule

designed to direct T cells towards MUC17-expressing cells. This is a first-in-human study in

adult subjects with MUC17-positive gastric cancer or gastroesophageal junction (GEJ) cancer,

to assess AMG 199 safety, tolerability, pharmacokinetics (PK), and anti-tumor activity, with

additional exploratory objectives to assess pharmacodynamics (PD), correlative biomarker

analysis, and immunogenicity.

The primary end point is to evaluate the safety and tolerability of AMG 199 in adult

subjects, and determine the MTD and RP2D. The secondary end point is characterize the PK and

anti-tumor activity of AMG 199.

Ein-/Ausschlusskriterien

Inclusion Criteria:

Key Inclusion Criteria:

- Subjects with histologically or cytologically confirmed metastatic or locally advanced

unresectable gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma

positive for MUC17. 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 one measurable lesion ≥ 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:

Key Exclusion Criteria:

- Any anticancer therapy or immunotherapy within 4 weeks of start of first dose.

- Central nervous system (CNS) metastases, leptomeningeal, or spinal cord compression.

- Autoimmune disorders requiring chronic systemic steroid therapy or any other form of

immunosuppressive therapy. Subjects may be included if the treatment is discontinued

more than 3 months prior to the first dose of AMG 199, there is a low likelihood of

relapse from the autoimmune disorder, AND there is agreement between the investigator

and the Amgen Medical Monitor.

Studien-Rationale

Primary outcome:

1. Incidence of Dose-limiting toxicities (DLT) (Time Frame - 2 years):
To evaluate the safety and tolerability of AMG 199 in adult subjects and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

2. Incidence of Treatment-emergent adverse events (TEAEs) (Time Frame - 2 years):
To evaluate the safety and tolerability of AMG 199 in adult subjects and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

3. Incidence of Treatment-related adverse events (TRAEs) (Time Frame - 2 years):
To evaluate the safety and tolerability of AMG 199 in adult subjects and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

4. Number of subjects with changes in vital signs (Time Frame - 2 years):
To evaluate the safety and tolerability of AMG 199 in adult subjects and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

5. Number of subjects with changes in clinical laboratory tests (Time Frame - 2 years):
To evaluate the safety and tolerability of AMG 199 in adult subjects and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

6. Number of subjects with changes in electrocardiogram (ECG) (Time Frame - 2 years):
To evaluate the safety and tolerability of AMG 199 in adult subjects and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

Secondary outcome:

1. Maximum serum concentration (Cmax) of AMG 199 (Time Frame - 2 years):
To characterize the PK (Pharmacokinetics) of AMG 199.

2. Minimum serum concentration (Cmin) of AMG 199 (Time Frame - 2 years):
To characterize the PK (Pharmacokinetics) of AMG 199.

3. Area under the concentration-time curve (AUC) of AMG 199 (Time Frame - 2 years):
To characterize the PK (Pharmacokinetics) of AMG 199.

4. Accumulation following multiple dosing of AMG 199 (Time Frame - 2 years):
To characterize the PK (Pharmacokinetics) of AMG 199.

5. Half-life (t1/2) of AMG 199 (Time Frame - 2 years):
To characterize the PK (Pharmacokinetics) of AMG 199.

6. Objective response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST. (Time Frame - 2 years):
To evaluate preliminary anti-tumor activity of AMG 199

7. Duration of response (DOR). (Time Frame - 2 years):
To evaluate preliminary anti-tumor activity of AMG 199

8. Time to progression (TTP) (Time Frame - 2 years):
To evaluate preliminary anti-tumor activity of AMG 199

9. Progression-free survival (PFS), 6-month PFS (Time Frame - 6 months):
To evaluate preliminary anti-tumor activity of AMG 199

10. Progression-free survival (PFS), 1-year PFS (Time Frame - 1 year):
To evaluate preliminary anti-tumor activity of AMG 199

11. Overall survival (OS), 1-year OS. (Time Frame - 1 year):
To evaluate preliminary anti-tumor activity of AMG 199

12. Overall survival (OS), 2-year OS (Time Frame - 2 years):
To evaluate preliminary anti-tumor activity of AMG 199

Studien-Arme

  • Experimental: Dose-exploration phase
    The dose-exploration phase of the study will estimate the MTD (Maximum Tolerated Dose) of AMG 199 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 phase
    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 199:
    AMG 199 is a BiTE® molecule designed to direct T cells towards MUC17-expressing cells.

Quelle: ClinicalTrials.gov


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