NCT04291079

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, Open-Label, Dose-Escalation, and Dose-Expansion Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of SRK-181 Alone and in Combination With Anti-PD-(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Scholar Rock, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cancer

Interventions

Type	Name	Description
BIOLOGICAL	SRK-181	anti-latent TGFβ1 monoclonal antibody
BIOLOGICAL	anti-PD-(L)1 antibody therapy	approved anti-PD-(L)1 antibody therapy for each tumor type

Timeline

• Start date: 2020-04-23
• Primary completion: 2025-04-14
• Completion: 2025-04-14
• First posted: 2020-03-02
• Last updated: 2025-04-29

Locations

22 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study