NCT04123574

A Pilot Study of BXCL701 in Patients With Pancreatic Cancer

A Pilot Proof of Mechanism Study of BXCL701, a Small Molecule Inhibitor of Dipeptidyl Peptidases (DPPs), in Patients With Pancreatic Cancer

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: BioXcel Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A study to assess the biochemical and immunomodulatory effects of BXCL701 in pancreatic cancer.

Detailed description

This is a Phase 0 or "window of opportunity" study where paired specimen analysis, taken before and after drug exposure, will permit the evaluation of target modulation and assessment of immune effector cell infiltration into the tumor and the generation of relevant immune cytokines. In this study, BXCL701 will be administered at a dose of 0.3 mg, twice daily for a total daily dose of 0.6mg (the previously defined maximum tolerated dose \[MTD\] of the drug), to all patients for a short period of 14 days. This study is designed to assess the biochemical and immunomodulatory effects of BXCL701 in pancreatic cancer.

Conditions

• Cancer of Pancreas
• Cancer of the Pancreas
• Neoplasms, Pancreatic
• Pancreas Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Talabostat Mesylate	BXCL701 tablets dosage strengths include 0.2mg and 0.05mg tablets for oral administration. Patients are to self-administer the prescribed number of BXCL701 tablets for a total daily dose of 0.6 mg. BXCL701 should not be taken on an empty stomach. Daily blood pressure monitoring will be performed during the dosing period. Administration of at least 1L of intravenous (IV) fluids is required on Day 1. On days when pharmacokinetic (PK) assessments are being performed, BXCL701 should be administered at the study center and should be administered at (approximately) the same time of day on each treatment day.

Timeline

• Start date: 2019-10-15
• Primary completion: 2021-12-06
• Completion: 2021-12-06
• First posted: 2019-10-11
• Last updated: 2022-02-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study