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Recruiting EARLY_Phase 1 NCT07274813

A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors

Trial Parameters

Condition Advanced/Metastatic Solid Tumors
Sponsor Shanghai Henlius Biotech
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 254
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-12-29
Completion 2027-03-30
Interventions
HLX37

Brief Summary

This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX37 in patients with advanced/metastatic solid tumors.

Eligibility Criteria

Selection criteria * Before the trial, fully understand the content, process and possible adverse reactions of the trial, sign the informed consent form, voluntarily participate in the trial, and be able to complete the research in accordance with the requirements of the trial protocol. * At the time of signing the ICF, the applicant must be at least 18 years old and no more than 75 years old, with no gender restrictions. * part 1 of Stage Ia enrolled subjects with advanced or metastatic solid tumors confirmed by histology or cytology, who had failed at least one standard systemic treatment in the advanced or metastatic stage of the disease (subjects who had received neoadjuvant or adjuvant therapy, if disease progression or recurrence occurred within 6 months after the end of treatment) Then this treatment plan will be regarded as a failure of standard treatment, or there is currently no effective standard treatment method. Part 2 of stage Ia enrollment confirmed by histology or cytol

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