A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Soli… (NCT07274813) | Clinical Trial Compass
RecruitingEarly Phase 1
A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors
China254 participantsStarted 2025-12-29
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 cytology Locally advanced (stage â…¢B/â…¢C) or metastatic (stage IV) NSCLC that is not suitable for radical treatment (complete surgical resection, concurrent/sequential chemoradiotherapy) (according to the 8th edition of lung cancer TNM staging by the Union for International Cancer Control and the American Joint Committee on Cancer AJCC), and should meet the following criteria:
Subjects without targeted driver gene alterations (AGA) :
For non-squamous NSCLC subjects, there must be previous test resu…
What they're measuring
1
The Dose-Limiting Toxicity (DLT) of HLX37 within 21 days after the first Administration
Timeframe: From first dose to the end of Cycle 1 (each cycle is 3 weeks)
2
2. The maximum tolerated dose (MTD) of HLX37
Timeframe: From first dose to the end of Cycle 1 (each cycle is 3 weeks)