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LM716

Phase 1

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

LM716 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

LM716 clinical trials

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
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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?

LM716 is an investigational small molecule developed by Novartis AG for the treatment of neoplasms, specifically advanced solid tumors. It is in Phase 1 clinical development in oncology and has been studied in a biomarker-selected patient population. LM716 has not been approved by the FDA and remains an investigational agent.

What is LM716 used for?

LM716 is being studied for use in patients with neoplasms, including advanced solid tumors. The clinical program has focused on biomarker-selected patients, meaning enrollment has been limited to those whose tumors express a specific biomarker. It is investigational and has not been approved for any indication.

Who makes LM716?

LM716 is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor of the clinical program evaluating LM716 in oncology, including the Phase 1 study conducted in Japanese patients with advanced solid tumors.

What phase is LM716 in?

LM716 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The completed study enrolled 12 patients and was an uncontrolled, non-randomized, open-label trial, so it did not include a placebo or comparator arm.

What clinical trials is LM716 in?

LM716 has been evaluated in one completed Phase 1 trial, NCT01911936, titled A Phase I Study of LJM316 in Japanese Patients With Advanced Solid Tumors. The study enrolled 12 patients aged 18 years and older in Japan and included both male and female participants. No trials of LM716 are currently active.

Is LM716 the same as LJM716?

Yes, LM716 and LJM716 refer to the same investigational compound from Novartis. The completed Phase 1 trial in Japanese patients with advanced solid tumors is registered under the name LJM716, while LM716 is the shorter form of the same drug name used in reference materials.