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AMG 172

Phase 1

Renal Cell Adenocarcinoma | Small molecule | Oncology |Amgen Inc.|Last Updated: Mar 25, 2016

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

AMG 172 · 1 trial · 4 indications

Phase 1 1
NCT01497821AMG 172 First in Human Study in Patients With Kidney CancerRenal Cell Adenocarcinoma
COMPLETED37 Analytics
PHASE1COMPLETED
AMG 172 First in Human Study in Patients With Kidney Cancer
Renal Cell AdenocarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinically significant or ≥ Grade 3 CTCAE changes in safety laboratory tests, physical examinations, ECGs, or vital signs
28 days after the last subject enrolled of each cohort in Part 1 and every 10 subjects enrolled in Part 2 (if available)
PK parameters including but not limited to, maximum observed concentration (Cmax), area under the concentration-time curve (AUC) and half life (t1/2)
12 time points up to 8 weeks
Objective response rate for subjects treated at MTD based on RECIST 1.1
3 years
The MTD for at least one of two dosing schedules: every two weeks or every three weeks
3 years

Secondary Endpoints

Development of human anti-human antibody against AMG 172
1 year
Objective response rate for subjects not treated at MTD based on RECIST 1.1
3 years
Clinical benefit as measured by duration of response per RECIST 1.1
3 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose explorationEXPERIMENTALPre-specified nominal doses are proposed in the dose exploration at two dosing frequencies: every two weeks and every three weeks. Intermediate doses may also be used if required based on the Continuous Reassessment Method (CRM) design.
Dose expansionEXPERIMENTALDose and dosing frequency selected from Part 1 dose exploration.

Interventions

NameTypeDescription
AMG 172DRUGAMG 172 is an antibody drug conjugate
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Subjects must have a pathologically documented, definitively diagnosed, clear cell RCC that is relapsed/refractory following at least two lines of systemic therapy (one of which must be a tyrosine kinase), or the subject refuses standard therapy * Measurable disease per RECIST...

Countries:United StatesFranceGermany
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Frequently asked questions about AMG 172

What is AMG 172 used for?

AMG 172 is an investigational small molecule being developed for the treatment of renal cell adenocarcinoma, which includes clear cell renal carcinoma and clear cell renal cell carcinoma. It is being studied in patients with kidney cancer.

Who makes AMG 172?

AMG 172 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company sponsored the first-in-human study of this investigational drug.

What phase is AMG 172 in?

AMG 172 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 first-in-human study in patients with kidney cancer has been completed.

What clinical trials is AMG 172 in?

AMG 172 has been studied in one clinical trial, NCT01497821, titled "AMG 172 First in Human Study in Patients With Kidney Cancer." This Phase 1 study enrolled 37 participants and was conducted in the United States, France, and Germany. The trial has been completed.

How does AMG 172 work?

AMG 172 is a small molecule therapeutic. Its specific molecular target has not been disclosed in available information, so its mechanism of action is not detailed here.