NCT06516887

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Specific Aim 1. Determine the safety, tolerability and maximum tolerated dose (MTD) of pacritinib in combination with bemcentinib in patients with advanced lung adenocarcinoma. We propose a prospective, open-label, phase Ib trial to evaluate safety, tolerability and MTD of pacritinib (JAK2 inhibitor) in combination with bemcentinib (AXL inhibitor) in patients with treatment refractory lung adenocarcinoma. The primary objectives of the phase Ib study are to determine the maximum tolerated dose (MTD), pharmacokinetics/pharmacodynamics (PK/PD), dose-limiting toxicities (DLTs) and efficacy of oral pacritinib in combination with bemcentinib. This phase Ib part of the study will use a Bayesian Optimal Interval (BOIN)70 design to determine MTD. This Bayesian dose-finding approach combines the ease of implementation of the traditional "3+3" design with the improved performance of more complex model-based designs in terms of accurately identifying the MTD. Compared to the modified probability toxicity interval design, it has a substantially lower risk of overdosing patients and generally has a higher probability of correctly selecting the MTD. In the phase Ib part of the study, subjects with advanced lung adenocarcinoma will be treated with pacritinib in combination with bemcentinib at increasing doses until MTD for combination treatment has been established. Six dose levels of combination treatments will be considered.

Conditions

• Advanced Lung Adenocarcinoma

Interventions

Type	Name	Description
DRUG	bemcentinib	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.
DRUG	pacritinib	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.

Timeline

• Start date: 2024-12-27
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2024-07-24
• Last updated: 2025-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study