Study of SBP-101 in Pancreatic Cancer

Study Overview

This phase 1 first-in-human study evaluates safety and tolerability of SBP-101 in subjects with previously treated pancreatic ductal adenocarcinoma and will identify the maximum tolerated dose (MTD). In addition, this study will also assess the pharmacokinetic (PK) profile and preliminary efficacy of SBP-101.

This first-in-human study of SBP-101 will be conducted in two phases: dose escalation and expansion. The dose escalation phase of the study is to evaluate the safety, tolerability and PK profile of SBP-101 in subjects with previously treated locally advanced or metastatic pancreatic ductal adenocarcinoma. Up to 48 subjects may be enrolled in dose escalation. The expansion phase of the study will consist of 24 additional subjects who will receive the maximum tolerated dose of SBP-101 based on data from the dose escalation phase of the study.

Pancreatic Cancer
Ductal Adenocarcinoma of the Pancreas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-12-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-04-18
First Submitted that Met QC Criteria 2016-01-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-04-20
First Posted (ACTUAL) 2016-01-15	Results First Posted N/A	Last Verified 2018-04

Study Registration Dates

Results Reporting Dates

Study Record Updates

First Submitted

2015-12-22

Results First Submitted

N/A

Last Update Submitted that met QC Criteria

2018-04-18

First Submitted that Met QC Criteria

2016-01-13

Results First Submitted that Met QC Criteria

N/A

Last Update Posted (ACTUAL)

2018-04-20

First Posted (ACTUAL)

2016-01-15

Results First Posted

N/A

Last Verified

2018-04

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: SBP-101 SBP-101 is administered as a subcutaneous injection once daily, Monday through Friday for 3 weeks (total of 15 doses) followed by a 5-week rest period (3 weeks on, 5 weeks off = 1 treatment cycle). Dose escalation in phase 1a will continue until the maxim	DRUG: SBP-101 Subcutaneous drug, escalating dose cohorts

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: SBP-101

SBP-101 is administered as a subcutaneous injection once daily, Monday through Friday for 3 weeks (total of 15 doses) followed by a 5-week rest period (3 weeks on, 5 weeks off = 1 treatment cycle). Dose escalation in phase 1a will continue until the maxim

DRUG: SBP-101

Subcutaneous drug, escalating dose cohorts

Primary Outcome Measures	Measure Description	Time Frame
Maximum tolerated dose of SBP-101		Up to 18 months following the first dose of treatment

Primary Outcome Measures

Measure Description

Time Frame

Maximum tolerated dose of SBP-101

Up to 18 months following the first dose of treatment

Secondary Outcome Measures	Measure Description	Time Frame
Number of subjects with adverse events as a measure of safety and tolerability		Up to 30 months following the first dose of treatment
Tumor response will be evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) definitions		Every 8 weeks during treatment assessed up to 30 months
Area under the plasma concentration versus time curve (AUC)		Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)
Peak plasma concentration (Cmax)		Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)
Plasma drug half-life		Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)

Secondary Outcome Measures

Measure Description

Time Frame

Number of subjects with adverse events as a measure of safety and tolerability

Up to 30 months following the first dose of treatment

Tumor response will be evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) definitions

Every 8 weeks during treatment assessed up to 30 months

Area under the plasma concentration versus time curve (AUC)

Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)

Peak plasma concentration (Cmax)

Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)

Plasma drug half-life

Days 1 and 18 of Cycle 1 (each cycle is 8 weeks)

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.