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LM716

Phase 1

Neoplasms | Small molecule | Oncology |Novartis AG|Last Updated: Dec 17, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

LM716 · 1 trial · 1 indication

Phase 1 1
NCT01911936A Phase I Study of LJM716 in Japanese Patients With Advanced Solid TumorsNeoplasms
COMPLETED12 Analytics
PHASE1COMPLETED
A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of dose-limiting toxicities (DLTs) in the dose escalation part
First cycle (28 days)

Secondary Endpoints

Frequency and severity of adverse events, number of and reasons for
from informed consent till 30 days after end of treatment
LJM716 serum concentration-time- profile and estimated PK
up to 10 cycle (1 cycle = 28 days)
Tumor response according to RECIST 1.1
every 2 months until end of treatment up to 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LJM716EXPERIMENTAL -

Interventions

NameTypeDescription
LM716DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Patients with the following indications: i) (Dose escalation part only): HER2 overexpressing locally advanced/ metastatic breast cancer or gastric cancer for which no effective treatment option exists: * For breast cancer: documented 3+ by immunohistochemistry, or ampl...

Countries:Japan
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Frequently asked questions about LM716

What is LM716 used for?

LM716 is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is being developed as a potential oncology therapy for patients with advanced solid tumors.

Who makes LM716?

LM716 is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the safety and efficacy of LM716 in patients with cancer.

What phase is LM716 in?

LM716 is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The Phase 1 study was designed to evaluate the safety, tolerability, and pharmacokinetics of LM716 in patients with advanced solid tumors.

What clinical trials is LM716 in?

LM716 has been studied in one clinical trial with the identifier NCT01911936. This was a Phase 1 study conducted in Japanese patients with advanced solid tumors. The trial has been completed and enrolled a total of 12 participants.

Is LM716 the same as LJM716?

Yes, LM716 is also known as LJM716. The clinical trial NCT01911936, titled 'A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors,' refers to the same drug. Both names are used interchangeably in clinical research.