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A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study of MC002
Sponsor: Hangzhou MacroLink Biopharmaceutical LLC
Summary
The goal of this clinical trial is to learn if ADC drug MC002 works to treat locally advanced/metastatic solid tumors in adults. It will also learn about the safety of MC002. The main questions it aims to answer are: Does participants tolerate the drug MC002 ? What medical problems do participants have when treating with MC002? Does participants benefit from the MC002 . Participants will: Intravenous infusion MC002 every 3 weeks in clinical Visit the clinic once every 3 weeks for checkups and tests Keep a diary of their symptoms
Official title: A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics, and Preliminary Efficacy of MC002 in Participants With Locally Advanced/Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
143
Start Date
2026-09
Completion Date
2028-06
Last Updated
2026-07-24
Healthy Volunteers
No
Interventions
antibody-drug conjugate
MC002 is a recombinant antibody-drug conjugate targeting the oncofetal antigen.