NCT02657330

Study of SBP-101 in Pancreatic Cancer

A Phase 1A/1B Study of SBP-101 in Previously Treated Subjects With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Panbela Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Cancer
• Ductal Adenocarcinoma of the Pancreas

Interventions

Type	Name	Description
DRUG	SBP-101	Subcutaneous drug, escalating dose cohorts

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2016-01-15
• Last updated: 2018-04-20

Locations

4 sites across 2 countries: United States, Australia