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NCT03565445 · ClinicalTrials.gov registry record · Phase 1
A Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors
A Phase 1 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 190
- Enrollment target
NCT03565445: Completed Phase 1 study, sponsored by Astellas Pharma Global Development.
NCT03565445 is a Phase 1 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 190 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (217% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03565445, a Phase 1 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 190 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the tolerability and safety profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab and determine the recommended Phase 2 dose (RP2D) of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab. This study will also evaluate the antitumor effect of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab.
Primary Outcome
DLT is any AE that cannot be attributed to a cause other than study drug: Grade (Gr) 4 NTP or Gr ≥ 3 febrile NTP Gr 4 TCP; or Gr 3 TCP accompanied by bleeding that requires transfusion Gr 4 anemia or Gr 3 anemia requiring transfusion Gr ≥ 3 NHAE Gr ≥ 2 pneumonitis AST or ALT \> 5x upper limit of normal (ULN; Gr ≥ 3) without liver metastases AST or ALT \> 8 x ULN in participants with liver metastases AST or ALT \> 3 x ULN \& total bilirubin \> 2 x ULN (in participant with Gilbert syndrome: AST o
Interventions
- DRUG pembrolizumab
- DRUG nivolumab
- DRUG ASP1948
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2018-07-02 |
| Est. Completion | 2023-03-27 |
| Phase | Phase 1 |
What the finished NCT03565445 record still lists
NCT03565445 is an interventional study that assigns participants to a tested intervention. The registered 190 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 (217% higher).
The record links to 0 conditions, and to 3 interventions - of which pembrolizumab is the first listed.
NCT03565445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03565445 about?
NCT03565445 is a clinical study titled "A Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors". The purpose of this study is to evaluate the tolerability and safety profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ...
What is the current status of trial NCT03565445?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 190 participants. The study started on 2018-07-02. Estimated completion is 2023-03-27.
What interventions are being tested in trial NCT03565445?
The interventions under investigation include: pembrolizumab (DRUG), nivolumab (DRUG), ASP1948 (DRUG).
Who is sponsoring clinical trial NCT03565445?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03565445's enrollment target sits among peer trials
190 284th of 2000 higher than 1,713 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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