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NCT06115642

A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors

Enrolling by Invitation
PHASE1Ages 18–75InterventionalTreatment
Shanghai Henlius Biotech
~367 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:HLX43HLX10

At a glance

Recruiting sites
0 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The Dose-Limiting Toxicity (DLT) of HLX43 within 21 days after the first Administration
Measured over From first dose to the end of Cycle 1 (each cycle is 3 weeks)
+3 more outcomes measured

Conditions

Advanced/Metastatic Malignant Solid Tumors

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NCT06115642

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, Chinano site contact published

  • Georgetown University

    Washington D.C., District of Columbiano site contact published

  • Kindai University Hospital

    Sayama, Osaka, Japanno site contact published

  • MD Anderson Medical Center

    Houston, Texasno site contact published

  • National Cancer Center Hospital

    Tokyo, Japanno site contact published

  • Okayama University Hospital

    Okayama, Japanno site contact published

  • Sendai Kousei Hospital

    Sendai, Miyagi, Japanno site contact published

  • Shizuoka Cancer Center

    Shizuoka, Japanno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jie Wang, Dr. · PRINCIPAL_INVESTIGATOR · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

What this trial measures

  • The Dose-Limiting Toxicity (DLT) of HLX43 within 21 days after the first AdministrationFrom first dose to the end of Cycle 1 (each cycle is 3 weeks)

    DLT refers to the AEs that are determined to be related to the investigational product by the investigator, whose severity will affect the escalation of dose level. In this study, the DLT observation period lasts for 21 days after the first administration of HLX43.

  • Objective response rate (ORR)approximately up to 24 months

    Percentage of participants with complete response (CR) and partial response (PR) based on investigator assessment.

  • The maximum tolerated dose (MTD) of HLX43From first dose to the end of Cycle 1 (each cycle is 3 weeks)

    The highest dose level, at which DLT is observed in no more than one of 6 evaluable patients, is defined as MTD of HLX43

  • RP2Dapproximately up to 24 months

    The recommended phase 2 dose of HLX43