Trials / Terminated
TerminatedNCT03588039
Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors
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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Athenex, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oraxol | Oral paclitaxel will be supplied in capsules and oral HM30181AK-US will be supplied in tablets |
| BIOLOGICAL | Pembrolizumab | Intravenously administered |
Timeline
- Start date
- 2018-10-25
- Primary completion
- 2023-05-12
- Completion
- 2023-05-12
- First posted
- 2018-07-17
- Last updated
- 2023-05-19
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03588039. Inclusion in this directory is not an endorsement.