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NCT04291079 · ClinicalTrials.gov registry record · Phase 1
SRK-181 Alone or in Combination With Anti-PD-(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON)
A Phase 1 study, sponsored by Scholar Rock.
- Completed
- Registry status
- Phase 1
- Development phase
- 112
- Enrollment target
NCT04291079 is a Phase 1 study that has completed, run by Scholar Rock. The registered enrollment target is 112 participants.
The verdict
NCT04291079, a Phase 1 study, has completed, sponsored by Scholar Rock.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 112 participants
- Enrollment target
Study Summary
This was a multi-center, open-label, Phase 1, first-in-human (FIH), dose-escalation, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SRK-181 administered alone and in combination with anti-PD-(L)1 therapy in adult patients with locally advanced or metastatic solid tumors. The study was divided into 3 treatment parts (Part A1, Part A2, and Part B) and a Long-Term Extension Phase (LTEP).
Interventions
- BIOLOGICAL SRK-181
- BIOLOGICAL anti-PD-(L)1 antibody therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2020-04-23 |
| Est. Completion | 2025-04-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04291079
The ClinicalTrials.gov registry entry for NCT04291079 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Scholar Rock, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SRK-181 is the first listed.
NCT04291079 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04291079 about?
NCT04291079 is a clinical study titled "SRK-181 Alone or in Combination With Anti-PD-(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON)". This was a multi-center, open-label, Phase 1, first-in-human (FIH), dose-escalation, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SRK-181 administered alone and in combination with anti-PD-(L)1 therapy in adult patients ...
What is the current status of trial NCT04291079?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 112 participants. The study started on 2020-04-23. Estimated completion is 2025-04-14.
What interventions are being tested in trial NCT04291079?
The interventions under investigation include: SRK-181 (BIOLOGICAL), anti-PD-(L)1 antibody therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT04291079?
This trial is sponsored by Scholar Rock, which has 7 total clinical trials registered on ClinicalTrials.gov.
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