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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: Completed Phase 1 study, sponsored by Scholar Rock.
NCT04291079 is a Phase 1 study that has completed, run by Scholar Rock. The registered enrollment target is 112 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Dose limiting toxicities (DLTs), as assessed by the Investigator, but not including toxicities clearly related to disease progression or intercurrent illness
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 |
What the finished NCT04291079 record still lists
NCT04291079 is an interventional study that assigns participants to a tested intervention. The registered 112 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 (87% higher).
The record links to 0 conditions, and to 2 interventions - of which SRK-181 is the first listed.
NCT04291079 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04291079's enrollment target sits among peer trials
112 508th of 2000 higher than 1,489 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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