NCT06115642
A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors
Enrolling by Invitation
PHASE1Ages 18–75InterventionalTreatmentShanghai 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
Where it's being run
10 sites across 8 statesJapan3
California1
District of Columbia1
Texas1
Beijing Municipality1
Hu'nan1
Miyagi1
Osaka1
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