Spots Global Cancer Trial Database for Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors

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Trial Identification

Brief Title: Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors

Official Title: Phase 1 Study With Expansion Cohorts to Assess the Safety, Tolerability, and Activity of Oraxol (Paclitaxel + HM30181A) in Combination With Pembrolizumab in Subjects With Advanced Solid Malignancies

Study ID: NCT03588039

Conditions

Solid Tumor

Interventions

Oraxol

Pembrolizumab

Study Description

Brief Summary: This is an open-label, Phase 1 dose-escalation study followed by a 2-arm expansion cohort of Oraxol administered in combination with pembrolizumab.

Detailed Description: This is a two part study. The dose escalation part will enroll subjects with advanced solid tumors for which pembrolizumab is an FDA-approved therapy, to determine the MTD and identify the recommended phase 2 dose of paclitaxel administered as Oraxol in combination with pembrolizumab. Upon determination of the phase 2 dose, the dose expansion part will enroll subjects with advanced/metastatic gastric/gastro-esophageal, or NSCLC into 2 independent cohorts/arms to further evaluate the activity and safety of the study treatment.