A Phase Ib/II Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic and Efficacy Study of Bemcentinib Plus Pacritinib In Patients With Advanced Lung Adenocarcinoma
The University of Texas Health Science Center at San Antonio
Summary
This is a Phase Ib/II, open-label, single institution dose-escalation, safety, pharmacokinetics, pharmacodynamic and efficacy study.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients with histologically-or cytologically confirmed diagnosis of locally advanced and/or metastatic lung adenocarcinoma (Stage IV/AJCC Edition 8) (any PD-L1 status) without actionable driver mutations, who has failed at least one line of systemic treatment. Patients with locally advanced and/or metastatic lung adenocarcinoma with driver mutation who have failed standard targeted therapies can also be enrolled on this study. 2. Be refractory to, or intolerant of, an established therapy known to provide clinical benefit for their condition. Patients can be eligible fo…
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.
Location
- University of Texas Health Science Center at San AntonioSan Antonio, Texas