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DTA-H19

Phase 1

Pancreatic Neoplasms | Monoclonal antibody | Oncology |Chemomab Therapeutics Ltd.|Last Updated: Mar 20, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

DTA-H19 · 1 trial · 1 indication

Phase 1 1
NCT00711997Phase 1/2a DTA-H19 in Patients With Unresectable Pancreatic CancerPancreatic Neoplasms
COMPLETED9 Analytics
PHASE1COMPLETED
Phase 1/2a DTA-H19 in Patients With Unresectable Pancreatic Cancer
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Study Endpoints

Primary Endpoints

Maximal Tolerated Dose (MTD) & Dose Limiting Toxicity (DLT) of Intratumoral Injections of BC-819
Week 4

If 2 patients in any cohort experience DLTs, then the next lower dose will be considered the MTD if there is a lower dose cohort. A DLT is defined as grade 3 or greater toxicity judged to be at least possibly related to the investigational products.

Secondary Endpoints

Tumor Response
4 weeks
Tumor Resectability
5 to 6 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BC-819EXPERIMENTALIntratumoral administration of BC-819

Interventions

NameTypeDescription
DTA-H19BIOLOGICALCohort #1: 4 mg DTA-H19 intratumorally 2 times per week for 2 weeks Cohort #2: 8 mg DTA-H19 intratumorally 2 times per week for 2 weeks
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Eligibility Criteria

Age Range18 Years to 79 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Provide written informed consent and be between the ages of 18 and 79, inclusive. * Have unresectable, locally advanced adenocarcinoma of the pancreas proven by biopsy or cytology (defined as direct extension to the superior mesenteric artery and/or celiac axis with loss of a ...

Countries:United StatesIsrael
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Frequently asked questions about DTA-H19

What is DTA-H19 used for?

DTA-H19 is an investigational monoclonal antibody being studied for the treatment of pancreatic neoplasms, specifically unresectable pancreatic cancer. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who is developing DTA-H19?

DTA-H19 is being developed by Chemomab Therapeutics Ltd., a biopharmaceutical company traded on the Nasdaq under the ticker symbol CMMB.

What phase is DTA-H19 in?

DTA-H19 is in Phase 1 clinical development. A Phase 1/2a study of DTA-H19 in patients with unresectable pancreatic cancer has been completed.

What clinical trials is DTA-H19 in?

DTA-H19 has been studied in a Phase 1/2a clinical trial registered as NCT00711997, which evaluated the drug in patients with unresectable pancreatic cancer. This trial was conducted in the United States and Israel and has been completed.

Is DTA-H19 an antibody?

Yes, DTA-H19 is a monoclonal antibody, a type of biologic drug designed to target specific proteins involved in disease processes.