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NCT03102320 · ClinicalTrials.gov registry record · Phase 1
Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 173
- Enrollment target
NCT03102320: Completed Phase 1 study, sponsored by Bayer.
NCT03102320 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 173 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (188% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03102320, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 173 participants
- Enrollment target
Study Summary
The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule). Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker analyses.
Primary Outcome
During SLI, patients with cholangiocarcinoma received anetumab ravtansine in combination with cisplatin and patients with pancreatic adenocarcinoma received anetumab ravtansine in combination with gemcitabine. The highest dose of anetumab ravtansine that can be given so that not more than 1 out of 6 patients experiences a dose-limiting toxicity (DLT) during the DLT evaluation period were declared as the MTD for anetumab ravtansine in combination with cisplatin or with gemcitabine.
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG Anetumab ravtansine (BAY94-9343)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2017-05-26 |
| Est. Completion | 2021-07-26 |
| Phase | Phase 1 |
What the finished NCT03102320 record still lists
NCT03102320 is an interventional study that assigns participants to a tested intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (188% higher).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT03102320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03102320 about?
NCT03102320 is a clinical study titled "Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors". The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerab...
What is the current status of trial NCT03102320?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 173 participants. The study started on 2017-05-26. Estimated completion is 2021-07-26.
What interventions are being tested in trial NCT03102320?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), Anetumab ravtansine (BAY94-9343) (DRUG).
Who is sponsoring clinical trial NCT03102320?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03102320's enrollment target sits among peer trials
173 324th of 2000 higher than 1,677 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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