A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study of MC002
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou MacroLink Biopharmaceutical LLC
About this trial
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
Eligibility criteria
Qualifiers
18 years of age and over, male or female, able to understand and willing to sign the Informed Consent Form (ICF).
Life expectancy of 3 month or greater
participants with histologically or cytologically confirmed recurrent or metastatic unresectable advanced solid tumors who experience disease progression after receiving systemic standard therapy, or have no standard therapy.
At least one measurable lesion as assessed by RECIST 1.1
Disqualifiers
Pregnant or nursing females.Participants who have received chemotherapy, investigational therapy, immunotherapy, or any other antitumor active drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose.
Known hypersensitivity to either the drug substances or inactive ingredient
Participants who have undergone a bone marrow transplantation, solid organ transplantation, stem cell transplant.
Participants with QTc >470 msec.
Trial design
Treatments tested in this trial
- MC002（ADC）
Treatment groups
143 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov