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

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).

Timeline

Start

2020-04-23

Primary completion

2025-04-14

Completion

2025-04-14

Outcome

Met primary endpoint

paper All primary and secondary objectives were met in the study. PMID 41530380 ↗

release “The Company believes these data from the Phase 1 DRAGON trial supports proof of concept and that the trial has met its primary objectives.” scholarrock.com ↗

Publications

• Yap TA, Sweis RF, Vaishampayan U, Kilari D, Gainor JF, McKean M, Barve M, Tarhini AA, Bockorny B, Sonpavde G, Park D, Babu S, Ju Y, Liu L, Henry S, Tirucherai GS, DeWall S, Qatanani M, Marantz JL, Gan L. Linavonkibart and pembrolizumab in immune checkpoint blockade-resistant advanced solid tumors: a phase 1 trial. Nat Med. 2026 Mar;32(3):992-1001. doi: 10.1038/s41591-025-04157-w. Epub 2026 Jan 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LINAVONKIBART	Monoclonal antibody	1000 mg	—
Subject	LINAVONKIBART	Monoclonal antibody	1500 mg	—
Subject	LINAVONKIBART	Monoclonal antibody	2000 mg	—
Subject	LINAVONKIBART	Monoclonal antibody	3000 mg	—
Background	Pembrolizumab	Monoclonal antibody	200 mg	—

Indications