SY-5007

DRUG4 trials

Sponsors

Shouyao Holdings (Beijing) Co. LTD

Conditions

Health SubjectsHealthy SubjectsMedullary Thyroid CancerNon-Small Cell Lung CancerSolid Tumor

Phase 1

Phase I/II Study of SY-5007, a RET Inhibitor, in Patients With RET-altered Advanced Solid Tumor

Shouyao Holdings (Beijing) Co. LTDMedullary Thyroid Cancer, Non-Small Cell Lung Cancer, Solid Tumor

Start: 2021-04-23End: 2025-02-10Target: 184Updated: 2023-04-12

A Study to Evaluate the Food Effects on Pharmacokinetics of SY-5007 Tablets in Healthy Subjects

Not yet recruitingNCT06325761

Shouyao Holdings (Beijing) Co. LTDHealth Subjects

Start: 2024-04-01End: 2024-05-01Target: 28Updated: 2024-03-22

A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of SY-5007 in Healthy Subjects

Not yet recruitingNCT06332053

Shouyao Holdings (Beijing) Co. LTDHealthy Subjects

Start: 2024-04-01End: 2024-06-01Target: 28Updated: 2024-03-27

Phase 3

Phase III Study of SY-5007, a RET Inhibitor, in Patients With Locally Advanced or Metastatic RET Fusion-positive NSCLC

Active, not recruitingNCT06031558

Shouyao Holdings (Beijing) Co. LTDNon-Small Cell Lung Cancer

Start: 2023-10-31End: 2026-06-20Target: 120Updated: 2026-06-16

Related Papers

Clinical efficacy and tolerability of the selective RET inhibitor soxataltinib (SY-5007) in advanced <i>RET</i> fusion–positive non–small cell lung cancer (NSCLC): Primary findings from a confirmatory phase III trial.

Journal of Clinical Oncology2026-05-28

First-in-human, phase 1 dose-escalation and dose-expansion study of a RET inhibitor SY-5007 in patients with advanced RET-altered solid tumors.

2024-11-045 citations

Efficacy and safety of SY-5007, a highly potent and selective RET inhibitor, in Chinese patients with advanced<i> RET</i>-fusion positive non-small cell lung cancer (NSCLC): Results from a multicenter, single-arm, phase II study.

Journal of Clinical Oncology2024-06-013 citations

A first-in-human phase I, dose-escalation and dose-expansion study of SY-5007, a highly potent and selective RET inhibitor, in Chinese patients with advanced <i>RET</i> positive solid tumors.

Journal of Clinical Oncology2023-06-017 citations