Neoplasms

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Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Pancreatic Neoplasms

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Gastrointestinal Neoplasms

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Endocrine Gland Neoplasms

Gastrointestinal Diseases

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Endocrine System Diseases

Pancreatic Cancer

All Drugs and Chemicals

Antineoplastic Agents

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Anti-Infective Agents

Antibodies

Gemcitabine

Immunoglobulins

Pancrelipase

Pancreatin

Milk fat globule

Antimetabolites

Imprime PGG with BTH1704 at assigned doses administered on days 1, 8, 15, and 22 of a 28-day cycle with Gemcitabine on days 1, 8, and 15, at assigned doses, of a 28-day cycle.

BTH1704 at assigned doses administered on days 1, 8, 15, and 22 of a 28-day (4 week) cycle.

BTH1704

Imprime PGG at assigned doses administered on days 1, 8, 15, and 22 of a 28-day (4 week) cycle.

IMPRIME PGG

Gemcitabine on days 1, 8, and 15, at assigned doses, of a 28-day (4 week) cycle.

Neeta Venepalli, MD

This Phase Ib dose escalation study will evaluate BTH1704, a monoclonal antibody that targets an aberrantly glycosylated antigen Mucin 1, and Imprime PGG, a glucan contained in yeast that is essential in triggering a leukocyte-mediated cytotoxic response towards tumor cells, in combination with gemcitabine in patients with advanced PDAC. The three intravenous drugs are taken in tandem 4 times in a 28-day cycle. The MAD of BTH1704 (BTH, 3 dose levels) in combination with gemcitabine (Gem) and Imprime PGG (I) will be determined using a standard "3+3" design. Treatment continues until disease progression, unacceptable toxicity, physician discretion, or patient refusal.

(PM-01) IMPRIME PGG® With BTH1704 and Gemcitabine for Advanced Pancreatic Cancer

PM-01: Phase 1b Study of PGG Beta Glucan (Imprime PGG®) in Combination With Anti-MUC1 Antibody (BTH1704) and Gemcitabine (Gemzar®) for the Treatment of Advanced Pancreatic Cancer

The primary objective of this Phase 1b study is to determine the maximal administered dose (MAD) of BTH1704 (Mucin-1 targeted antibody) in combination with gemcitabine and Imprime PGG (beta 1,3/1,6 glucan) when given to patients with advanced and previously treated pancreatic ductal adenocarcinoma (PDAC).

Characterize adverse effects (AE) of I-BTH-Gem in patients with advanced PDAC in the second and third line setting.

Evaluate clinical response of I-BTH-Gem in patients with advanced PDAC in the second and third line setting (RECIST v 1.1).

HiberCell, Inc.

University of Illinois at Chicago

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
(PM-01) IMPRIME PGG® With BTH1704 and Gemcitabine for Advanced Pancreatic Cancer	NCT02132403	Pancreatic Canc...	BTH1704 IMPRIME PGG Gemcitabine	18 Years -	University of Illinois at Chicago
(PM-01) IMPRIME PGG® With BTH1704 and Gemcitabine for Advanced Pancreatic Cancer	NCT02132403	Pancreatic Canc...	BTH1704 IMPRIME PGG Gemcitabine	18 Years -	University of Illinois at Chicago

Spots Global Cancer Trial Database for adenocarcinoma of the pancreas (pdac)