A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors

Launched by MABWELL (SHANGHAI) BIOSCIENCE CO., LTD. · Mar 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called 9MW2821 for patients with advanced malignant solid tumors, which are cancerous growths that can occur in various parts of the body. This is the first time this treatment is being tested in humans, and the trial aims to understand how safe it is, how well it works, and how the body processes it. The study is currently recruiting participants who are between 18 and 80 years old and have already tried other cancer treatments. Eligible participants must have a certain level of physical ability and life expectancy, and they need to agree to follow the study guidelines.

Participants in this trial will receive the treatment through an intravenous (IV) infusion, meaning it will be delivered directly into their bloodstream. They will also need to provide tumor samples for testing and attend regular follow-up appointments. It's important to know that certain health conditions or recent treatments may prevent someone from joining the study. Overall, this trial could provide valuable information about a potential new option for treating advanced solid tumors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
• • Male or female subjects aged 18 to 80 years (including 18 and 80 years).
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• • Phase Ia：Histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma). Phase Ib：Only local advanced or metastatic UC tumors.
• • Subjects must have received ICIs or GC/GP therapies in the previous treatment.
• • Subjects must submit tumor tissues for test.
• • Life expectancy of ≥ 3 months.
• • Subjects must have measurable disease according to RECIST (version 1.1).
• • Adequate organ functions.
• • Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
• • Subjects are willing to follow study procedures.
• Exclusion Criteria:
• • Chemotherapy、radiotherapy or immunotherpy within 14 days prior to the first dose of study drug.
• • Preexisting treatment related toxicity Grade ≥ 2 (except alopecia).
• • Major surgery within 28 days prior to first dose of study drug.
• • History of uncontrolled diabetes mellitus.
• • Preexisting peripheral neuropathy Grade ≥ 2.
• • Received treatment of ADCs with MMAE payload.
• • Any live vaccines within 4 weeks before first dose of study drug or during the study.
• • Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
• • Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.
• • Uncontrolled central nervous system metastases.
• • History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.
• • History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.
• • Has ocular conditions that may increase the risk of corneal epithelium damage.
• • Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
• • Any P-glycoprotein (P-gp) inducers/inhibitors or CYP3A4 inducers/inhibitors for high and medium effect within 14 days prior to the first dose of study drug.
• • Use of any investigational drug or device within 30 days prior to the first dose of study drug.
• • Conditions or situations which may put the subject at significant risk.