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siG12D LODER

Phase 1

Pancreatic Ductal Adenocarcinoma | Small molecule | Oncology |Silexion Therapeutics Corp|Last Updated: Apr 9, 2019

Success Probability

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

siG12D LODER · 1 trial · 2 indications

Phase 1 1
NCT01188785Phase I - Escalating Dose Study of siG12D LODER (Local Drug EluteR) in Patients With Locally Advanced Adenocarcinoma of the Pancreas, and a Single Dose Study of siG12D LODER (Local Drug EluteR) in Patients With Non-operable Adenocarcinoma of the PancreasPancreatic Ductal Adenocarcinoma
COMPLETED15 Analytics
PHASE1COMPLETED
Phase I - Escalating Dose Study of siG12D LODER (Local Drug EluteR) in Patients With Locally Advanced Adenocarcinoma of the Pancreas, and a Single Dose Study of siG12D LODER (Local Drug EluteR) in Patients With Non-operable Adenocarcinoma of the Pancreas
Pancreatic Ductal AdenocarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Adverse Events
Phase 0 - 6 weeks, Phase I - 2 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1 armEXPERIMENTALSOC + siG12D LODER

Interventions

NameTypeDescription
siG12D LODERDRUGPhase 0 - subjects diagnosed with an operable adenocarcinoma of the pancreas will have 8 siG12D LODER placed in tumor. The siG12D LODER will be placed in the subject's tumor using an EUS biopsy needle. Phase I - subjects diagnosed with locally non-operable advanced adenocarcinoma of the pancreas. These subjects will have one of three different siG12D LODERs dose levels placed in tumor - Either 1 siG12D LODER, 2 siG12D LODERs or 8 siG12D LODERs. The siG12D LODER/s will be placed in the subject's tumor using an EUS biopsy needle.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: Phase 0: Provide written informed consent and be between the ages of 18 and up, inclusive. * Patient that is diagnosed as respectable locally pancreatic tumor * Have a target tumor accessible for intratumoral administration by EUS (Endoscopic Ultrasound) guidance as determined...

Countries:Israel
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Frequently asked questions about siG12D LODER

What is siG12D LODER used for?

siG12D LODER is an investigational small molecule being developed for the treatment of Pancreatic Ductal Adenocarcinoma, a form of pancreatic cancer. It is designed as a local drug eluteR for patients with locally advanced or non-operable adenocarcinoma of the pancreas. The drug is currently in clinical development and is not yet approved.

What does siG12D LODER target?

siG12D LODER is a small molecule that targets the KRAS G12D mutation, a common oncogenic driver in pancreatic cancer. By delivering the drug locally, it aims to inhibit the activity of this mutated gene. The drug is being studied specifically in patients with Pancreatic Ductal Adenocarcinoma.

Who makes siG12D LODER?

siG12D LODER is being developed by Silexion Therapeutics Corp, a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with pancreatic cancer. Silexion Therapeutics Corp is publicly traded under the ticker symbol SLXN.

What phase is siG12D LODER in?

siG12D LODER is in Phase 1 clinical development. A Phase 1 trial has been completed, which was an escalating dose study in patients with locally advanced adenocarcinoma of the pancreas. The drug remains investigational and has not received regulatory approval for any indication.

What clinical trials is siG12D LODER in?

siG12D LODER has been studied in one completed Phase 1 clinical trial, identified as NCT01188785. This trial enrolled 15 participants and evaluated escalating doses of the drug in patients with locally advanced or non-operable adenocarcinoma of the pancreas. The study was conducted in Israel and included adults aged 18 years and older.

Is siG12D LODER the same as siG12D LODER?

siG12D LODER is the primary name for this investigational drug. It is also referred to as a local drug eluteR in the context of its delivery mechanism. No other alternative names have been established for this asset in clinical development.