NCT07726212Not yet recruitingPhase 1
A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study of MC002
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
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 143 (estimated)
- First submitted
- 10 Jul 2026
- Start date
- Sept 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Hangzhou MacroLink Biopharmaceutical LLC
- Diseases
- Lung cancer, Gastric and esophageal cancer
- NCT number
- NCT07726212
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 143
- From Sept 2026 to the primary completion date, Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Participants who have undergone a bone marrow transplantation, solid organ transplantation, stem cell transplant.
- Use of ≥10 mg of prednisone or equivalent dose of steroids per day within 3 months of administration (inhaled, intranasal, intraocular, topical and intraarticular joint injections of corticosteroids are allowed).Participants with a history of HCV infection who have not completed curative anti HCV treatment and whose HCV load is above the limit of quantification. Concurrent HCV treatment is not allowed in the trial.Live viral vaccine therapies within 4 weeks prior to the first dose of study drug.
- Participants who have received treatment with any herbal or alternative therapies within 7 days prior to the first dose of the study drug.
Other illness
- Known hypersensitivity to either the drug substances or inactive ingredient
Lab values
- Participants with QTc \>470 msec.
Other
- Male and female participants of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception
Who the study is looking for
- 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
- Adequate organ functions.
- ECOG Performance Status (PS) of 0-1
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.