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

NCT02132403 | Terminated Phase 1 DMC

• 1 other identifier: 2013-1115
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; adenocarcinoma of the pancreas (PDAC); mixed adenocarcinoma of the pancreas; locally advanced; recurrent; metastatic

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  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).

  Up to 30 days post last dose

Secondary Outcomes (2)

• Adverse Effects

  Up to 30 days post final dose

• Disease Response based on RECIST Criteria

  Up to 8 weeks following final dose.

Study Arms (1)

IMPRIME PGG, BTH1704, & Gemcitabine

EXPERIMENTAL

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.

Drug: BTH1704; Drug: IMPRIME PGG; Drug: Gemcitabine

Interventions

BTH1704 DRUG

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

Also known as: Humanized Human Milk Fat Globule 1 Antibody, huHMFG1, R1550, AS1402, Therex

IMPRIME PGG, BTH1704, & Gemcitabine

IMPRIME PGG DRUG

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

Also known as: Beta 1,3/1,6 glucan

IMPRIME PGG, BTH1704, & Gemcitabine

Gemcitabine DRUG

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

Also known as: Gemzar®

IMPRIME PGG, BTH1704, & Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years
• Histologically or cytologically confirmed adenocarcinoma of the pancreas, including pancreatic adenosquamous carcinoma, pancreatic anaplastic adenocarcinoma, pancreatic signet ring carcinoma, papillary mucinous carcinoma, acinar cell carcinoma, and ampulla of vater carcinoma,that is locally advanced (not able to proceed with surgery), recurrent, or metastatic (mixed adenocarcinoma of the pancreas is acceptable where the invasive component is predominantly adenocarcinoma)
• Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1
• Has an ECOG PS of 0, 1, or 2
• Has been off chemotherapy for \> or = 2 weeks
• Has a patent biliary stent if required for biliary ductal obstruction, has adequate nutritional intake, and pain which is stable for a minimum of 24 hrs (pain score ≤ 3/10)
• Has total bilirubin \< 2 mg/dL, AST and ALT \< 3.0 × ULN or \< 5 x ULN for subjects with known hepatic metastases
• Has serum creatinine \< 2.5 × ULN
• Has hemoglobin ≥ 9 g/dL, ANC ≥ 1.0 × 10\^9/L, and platelet count ≥ 100 × 10\^9/L
• Must be willing and able to comply with study
• Has read, understood and signed the ICF
• Women of childbearing potential must not be pregnant or breast-feeding. In addition, a medically acceptable method of birth control must be used or total abstinence. Women who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be WOCP.
• Men who are not surgically or medically sterile must agree to use an acceptable method of contraception. Male patients with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms at least 30 days after the last dose of study drug. Total abstinence is an acceptable alternative.
• Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy.
• Availability of tissue if applicable (from the primary tumor or metastases)for banking

You may not qualify if:

• Has a diagnosis of resectable pancreatic adenocarcinoma
• Had surgery within 4 weeks prior to study treatment
• Has either untreated or symptomatic CNS mets
• Has a known hypersensitivity to BTH1704, murine proteins, or any component of BTH1704
• Has a known hypersensitivity to baker's yeast
• Has had previous exposure to Imprime PGG
• Has previously received an organ or progenitor/stem cell transplant
• Has a history of blood clots, pulmonary embolism, or DVT unless controlled by anticoagulant treatment
• Has a known history of HIV positivity or untreated \& uncontrolled hepatitis B or C
• Has any clinically significant infection
• Has any other severe, uncontrolled medical condition, including uncontrolled DM or unstable CHF or has a known or suspected allergy to the study drug
• Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormality that may increase the risk associated with study participation
• Presence of any non-healing wound, fracture, or ulcer
• Has any condition that, in the opinion of the investigator, might jeopardize the safety of the patient or interfere with protocol compliance
• Has any mental or medical condition that prevents the patient from giving informed consent

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• HiberCell, Inc.: collaborator

Study Sites (1)

UI Cancer Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Anophthalmia with pulmonary hypoplasia; Recurrence; Neoplasm Metastasis

Interventions

epitumomab; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Neeta Venepalli, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 7, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 1, 2015

Record last verified: 2015-04

Locations

US (1)