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SRK-181 Alone or in Combination With Anti-PD-(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON)

NCT04291079 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2025-04-29

No results posted yet for this 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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Scholar Rock, Inc.

    lead INDUSTRY

Principal Investigators

  • Lu Gan, MD · Scholar Rock, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-23
Primary Completion
2025-04-14
Completion
2025-04-14
FDA Drug
Yes

Countries

  • United States
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04291079 on ClinicalTrials.gov