Status:
UNKNOWN
A Clinical Study of 9MW2821 in Subjects With Advanced Malignant Solid Tumors
Lead Sponsor:
Mabwell (Shanghai) Bioscience Co., Ltd.
Conditions:
Solid Tumors
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is a Phase 1/2, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity an...
Eligibility Criteria
Inclusion
- 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.
- Histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma).
- For Cohort Expansion: Subjects must submit tumor tissue for Nectin-4 expression.
- 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
- Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, or any other anticancer therapy 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 nectin-4 targeted ADC 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 within 14 days prior to the first dose of study drug
- Use of any investigational drug or device within 2 months prior to the first dose of study drug.
- Condition or situation which may put the subject at significant risk.
Key Trial Info
Start Date :
June 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT05216965
Start Date
June 11 2022
End Date
December 1 2025
Last Update
June 15 2022
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032