NCT05144334

A Study of BTX-1188 in Subjects With Advanced Malignancies

An Open Label, Escalating Multiple Dose Study to Evaluate the Safety, Toxicity, Pharmacokinetics, and Preliminary Activity of BTX-1188 in Subjects With Advanced Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Biotheryx, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open label, nonrandomized, sequential dose escalation, multiple dose study designed to evaluate the safety, toxicity, and pharmacokinetics (PK) as well as preliminary efficacy of BTX-1188 orally administered in subjects with advanced malignancies.

Detailed description

Study BTX-1188-001 is a multicenter, open label, nonrandomized, sequential dose escalation study to evaluate the safety, toxicity, PK, and preliminary efficacy of BTX-1188. Dose escalation will be conducted in subjects with acute myeloid leukemia (AML) and advanced lymphoid and solid tumors. Based on the results of the dose escalation, a recommended Phase 2 dose will be determined.

Conditions

• Advanced Solid Tumor
• Non Hodgkin Lymphoma
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	BTX-1188	One 28 day cycle of treatment will consist of 4 weeks of treatment with BTX-1188 administered orally per dosing schedule.

Timeline

• Start date: 2022-01-24
• Primary completion: 2023-09-12
• Completion: 2023-09-12
• First posted: 2021-12-03
• Last updated: 2023-09-18

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study