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AMG 337

Phase 1

Advanced Malignancy | Small molecule | Oncology |Amgen Inc.|Last Updated: Nov 7, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment111

FDA Designations

No designations recorded

Clinical trial landscape

AMG 337 · 2 trials · 7 indications

Phase 1 2
NCT02096666A Phase 1/2 Study Evaluating AMG 337 in Asian SubjectsStomach Neoplasms
COMPLETED11 Analytics
NCT01253707A Study of AMG 337 in Subjects With Advanced Solid TumorsAdvanced Malignancy
COMPLETED111 Analytics
PHASE1COMPLETED
A Phase 1/2 Study Evaluating AMG 337 in Asian Subjects
Stomach NeoplasmsUnlock trial analytics
PHASE1COMPLETED
A Study of AMG 337 in Subjects With Advanced Solid Tumors
Advanced MalignancyUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase 1- Adverse events and clinical laboratory abnormalities
17 months

Adverse events and clinical laboratory abnormalities defined as DLTs.

Phase 2- Overall Response Rate (per RECIST v1.1) in subjects with MET amplified measurable gastric/gastroesophageal junction/esophageal adenocarcinoma (cohort 1)
17 months

Determine anti-tumor activity of AMG 337 in subjects with MET amplified gastric/gastroesophageal junction/esophageal adenocarcinoma (cohort 1)

To evaluate the safety and tolerability of AMG 337 by reviewing clinically significant or ≥ Grade 3 changes in safety laboratory tests, physical examinations, ECGs, or vitals signs in all subjects enrolled.
4 years
Characterize the pharmacokinetics of AMG 337 when administered orally. PK parameters will include, but are not limited to, area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax).
4 years
Determine the maximum tolerated dose of AMG 337, if possible. The MTD is defined at the highest dose level with an observed incidence of dose limiting toxicity in < 33% of subjects enrolled in a cohort.
4 years

Secondary Endpoints

Phase 1- Pharmacokinetic parameters
17 months
Phase 1- Other adverse events, clinical laboratory abnormalities and ECG parameters
17 months
Phase 2- Overall Response Rate (per RECIST v1.1) in subjects with other MET amplified solid tumors (subjects with measurable disease in cohort 2)
17 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single armEXPERIMENTAL -
Dose EscalationEXPERIMENTAL -

Interventions

NameTypeDescription
AMG 337DRUGPhase 1- AMG 337 150 mg, 200mg and 300 mg orally daily. Additional 150 mg and 200 mg orally twice daily. Phase 2- AMG 337 (dose determined by Phase 1)
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Able to self administer daily AMG 337 as a whole capsule * Male or female 20 years of age or over * Phase 1: Subjects must have a pathologically confirmed, advanced solid tumor for which the subjects have received prior therapy for advanced disease, for which no standard thera...

Countries:JapanUnited States
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Frequently asked questions about AMG 337

What is AMG 337 used for?

AMG 337 is an investigational small molecule being studied for the treatment of stomach neoplasms and advanced malignancy. It is being developed by Amgen Inc. for oncology indications. As of the available data, AMG 337 is in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes AMG 337?

AMG 337 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is an investigational small molecule in Phase 1 clinical development for oncology indications, including stomach neoplasms and advanced malignancy.

What phase is AMG 337 in?

AMG 337 is in Phase 1 clinical development. It is an investigational small molecule being studied for stomach neoplasms and advanced malignancy. The drug has not been approved by regulatory authorities and remains in clinical trials.

What clinical trials is AMG 337 in?

AMG 337 has been studied in two completed Phase 1 clinical trials. NCT01253707 enrolled 111 participants with advanced solid tumors in the United States. NCT02096666 enrolled 11 participants with stomach neoplasms in Japan. Both trials are completed, and no active trials are currently listed.

Is AMG 337 the same as any other drug?

No alternative names for AMG 337 have been identified in the available data. The drug is referred to solely as AMG 337 in clinical trial records and development information.