Clinical Trial: NCT04291079
SRK-181 Alone or in Combination With Anti-PD-(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON)
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Scholar Rock, Inc. |
| Information Provided By: | Scholar Rock, Inc. |
| Last Update Posted: | 2025-04-29 |
Study Overview
Brief 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).
Official Title
Conditions
Intervention / Treatment
- Biological: SRK-181
- Biological: anti-PD-(L)1 antibody therapy
Other Study ID Numbers
- SRK-181-001
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Scholar Rock, Inc. |
| Information Provided By: | Scholar Rock, Inc. |
| Last Update Posted: | 2025-04-29 |
Study Overview
Brief 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).
Official Title
Conditions
Intervention / Treatment
- Biological: SRK-181
- Biological: anti-PD-(L)1 antibody therapy
Other Study ID Numbers
- SRK-181-001