A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study of MC002
NCT07726212 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 143
Last updated 2026-07-27
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
Conditions
- Advanced Esophageal Cancer
- Advanced Lung Cancer
Interventions
- DRUG
-
MC002(ADC)
MC002 is a recombinant antibody-drug conjugate targeting the oncofetal antigen.A complete treatment cycle is defined as 21 calendar days. MC002 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
Sponsors & Collaborators
-
Hangzhou MacroLink Biopharmaceutical LLC
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2027-12-31
- Completion
- 2028-06-30
- FDA Drug
- Yes
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