Study of Bemcentinib Plus Pacritinib In Patients With Advanced Lung Adenocarcinoma

Conditions

bemcentinib — DRUG
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.
pacritinib — DRUG
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.

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

Experimental: Pharmacokinetic Phase 1b (PK) Study Cohort
Patients will receive bemcentinib and pacritinib in combination from Days 1 to Day 28. PK samples will be collected on Day 1 (pre-dose, 4, 6h), pre-dose Day 2, Day 7 (pre-dose, 4h and 6h post-dose), pre-dose Day 8, pre-dose Day 14, and Day 22 (pre-dose and 6h post-dose) samples. The Day 22 sample will cover the steady state values for both compounds. Six dose levels of combination treatments will be considered: * Dose level -1: pacritinib 100 mg oral dose (p.o.) daily + bemcentinib 50 mg p.o. daily; * Dose level 1: pacritinib 100 mg oral dose (p.o.) twice daily (BID) + bemcentinib 50 mg p.o. daily; * Dose level 2: pacritinib 100 mg p.o. BID + bemcentinib 75 mg p.o. daily; * Dose level 3: pacritinib 100 mg BID + bemcentinib 100 mg p.o. daily; * Dose level 4: pacritinib 200 mg BID + bemcentinib 100 mg p.o. daily; * Dose level 5: pacritinib 200 mg BID + bemcentinib 125 mg p.o. daily.
Experimental: Phase II Cohort
Of these participants taking the Maximum tolerated dose, up to 15 will undergo a biopsy. Progression free survival will be the primary objective of this study phase.

Progression Free Survival (PFS) [ Time Frame: Up to 48 months ]

Facility	City	State	ZIP	Site coordinators
University of Texas Health Science Center at San Antonio	San Antonio	Texas	78229	-

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