NCT03412799

Study of SBP-101 Combined With Nab-Paclitaxel and Gemcitabine in Pancreatic Cancer

Phase 1A/1B Dose Escalation and Expansion Study of SBP-101 in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Panbela Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label phase 1A/1B study to assess the safety, tolerability and pharmacokinetics of SBP-101 when combined with nab-paclitaxel and gemcitabine in subjects with previously untreated metastatic pancreatic ductal adenocarcinoma and to identify a recommended phase 2 dose. The study will also assess preliminary efficacy of the 3-drug treatment combination.

Detailed description

The study will be conducted in two phases: dose escalation and expansion. Up to three dose levels of SBP-101 will be assessed in up to 18 subjects during dose escalation. The expansion phase of the study will consist of 10 additional subjects who will receive the recommended dose of SBP-101 combined with nab-paclitaxel and gemcitabine.

Conditions

• Pancreatic Cancer Metastatic
• Pancreatic Cancer Stage IV
• Stage IV Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	SBP-101	Administered as subcutaneous (SC) injection, escalating dose cohorts
DRUG	nab-paclitaxel	Administered as intravenous (IV) infusion
DRUG	Gemcitabine Injection	Administered as intravenous (IV) infusion

Timeline

• Start date: 2018-06-04
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2018-01-26
• Last updated: 2022-05-25

Locations

7 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study