RecruitingPhase 1Phase 2NCT07810933

A Phase 1/2 Study of SY-12321 in Patients With ALK-positive Advanced Malignancies

An Open-label, Multicenter Phase Ⅰ/Ⅱ Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SY-12321 in Patients With ALK-positive Advanced Malignancies

Sponsor

Shouyao Holdings (Beijing) Co. LTD

Enrollment

330 participants

Start Date

Aug 12, 2026

Study Type

INTERVENTIONAL

Conditions

ALK Positive Advanced Malignancies

Summary

A phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetic profiles, and preliminary efficacy of SY-12321 in trial participants with ALK-positive advanced malignancies, including non-small cell lung cancer (NSCLC), inflammatory myofibroblastic tumor (IMT), anaplastic large-cell lymphoma (ALCL), colorectal cancer, pancreatic cancer, breast cancer, and others.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called SY-12321 for people with alk positive advanced malignancies. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSY-12321

A fourth-generation ALK tyrosine kinase inhibitor (Other Names: SY-12321 capsules)

Locations(2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

View Full Details on ClinicalTrials.gov

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NCT07810933