RecruitingPhase 1Phase 2NCT06516887

Study of Bemcentinib Plus Pacritinib In Patients With Advanced Lung Adenocarcinoma

A Phase Ib/II Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic and Efficacy Study of Bemcentinib Plus Pacritinib In Patients With Advanced Lung Adenocarcinoma


Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

44 participants

Start Date

Dec 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase Ib/II, open-label, single institution dose-escalation, safety, pharmacokinetics, pharmacodynamic and efficacy study.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two targeted drugs — bemcentinib and pacritinib — in people with advanced or metastatic lung adenocarcinoma (a type of lung cancer) who have already tried at least one prior treatment. The goal of the first phase is to find the safest and most effective dose of this combination, and the second phase will further evaluate whether it works. Adults 18 and older with a confirmed diagnosis of advanced lung adenocarcinoma, adequate organ function, and good performance status may be eligible. Participation involves taking both medications orally, attending regular clinic visits, and possibly providing tumor biopsy samples for research. This summary was generated with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGbemcentinib

Bemcentinib has been investigated in a phase I/II clinical trials for solid tumors. Phase I and II clinical studies of BGB324 are ongoing in non-small cell carcinoma, in which combinations with other agents such as Phase I study of docetaxel (NCT02922777), erlotinib (NCT02424617), and pembrolizumab (NCT03184571) are also being investigated. In a phase I dose escalation study of bemcentinib in combination with docetaxel study, patients with treatment naïve, advanced lung adenocarcinoma receive docetaxel 75 mg/m2 given IV every 21 days in combination with bemcentinib. Bemcentinib dose will be escalated in a standard 3+3 fashion until a maximum tolerated dose is determined.

DRUGpacritinib

For use in clinical studies as an oral agent, pacritinib is supplied as size #0 hard gelatin capsules with gray bodies and scarlet caps. Capsules contain 100 mg pacritinib (free base) and the following inactive ingredients: microcrystalline cellulose NF, polyethylene glycol 8000 NF, and magnesium stearate NF. The capsule gelatin is bovine derived. Pharmacies at investigational sites will receive subject-specific bottles containing 120 capsules packaged in 200 mL high-density polyethylene bottles with child-resistant closures.


Locations(1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

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NCT06516887


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