Trials / Completed
CompletedNCT02013154
A Study of DKN-01 in Combination With Paclitaxel or Pembrolizumab
A Multi-part, Phase 1, Multi-center, Open-label Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel or Pembrolizumab in Patients With Relapsed or Refractory Esophagogastric Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 151 (actual)
- Sponsor
- Leap Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A study to evaluate the safety and tolerability of DKN-01 in combination with weekly paclitaxel or pembrolizumab in participants with relapsed or refractory Esophagogastric Malignancies
Detailed description
This is a dose-escalating, open-label study conducted in multiple parts (Part A dose-escalation, Parts B-F expansion cohorts, and a monotherapy substudy). Parts A-E (DKN-01 plus paclitaxel) and the DKN-01 monotherapy substudy includes 28-day cycle treatment cycles; Part F (DKN-01 plus pembrolizumab) includes 21-day treatment cycles. Depending on their cancer type, subjects with histologically confirmed recurrent or refractory esophageal, gastro-esophageal junction tumors, or gastric adenocarcinoma will be enrolled in each study part to receive DKN-01 150 mg or 300 mg in combination with paclitaxel or pembrolizumab. Subjects who are unable to receive paclitaxel or pembrolizumab for any reason are allowed to receive single agent DKN-01 300 mg as part of a monotherapy substudy. Results are reported by treatment group, irrespective of the study part in which the subject was enrolled.
Conditions
- Esophageal Neoplasms
- Adenocarcinoma of the Gastroesophageal Junction
- Gastroesophageal Cancer
- Squamous Cell Carcinoma
- Gastric Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DKN-01 150 mg | Administered by IV infusion |
| DRUG | Paclitaxel | Administered by IV infusion |
| DRUG | Pembrolizumab | Administered by IV infusion |
| DRUG | DKN-01 300 mg | Administered by IV infusion |
Timeline
- Start date
- 2014-05-05
- Primary completion
- 2019-07-19
- Completion
- 2021-01-11
- First posted
- 2013-12-17
- Last updated
- 2025-08-03
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02013154. Inclusion in this directory is not an endorsement.