A Phase I/II Study of 3H-10000 (an Anti-FGFR2b Antibody-Drug Conjugate) in Subjects With Unresectable or Metastatic Advanced Solid Tumors
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3H-10000 in the treatment of unresectable or metastatic solid tumors .
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Subjects must be willing and able to sign the ICF and to adhere to the study visit schedule and other protocol requirements.
• Male or female subjects aged ≥18 years at the time of signing the ICF.
• According to RECIST v1.1, there is at least one measurable lesion.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 point.
• Life expectancy of ≥3 months.
Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Contact Information
Primary
Shuchao Wu
shuchao.wu@3hpharma.com
0086-21-50895559
Time Frame
Start Date: 2026-01-04
Estimated Completion Date: 2029-01
Participants
Target number of participants: 170
Treatments
Experimental: Stage I - dose escalation
Dose escalation of 3H-10000 in patients with advanced solid tumors.
Experimental: stage II - expansion
Expansion evaluating the recommended dose and schedule of 3H-10000 identified from Stage I.
Related Therapeutic Areas
Sponsors
Leads: 3H Pharmaceuticals Co., Ltd.