Last updated: June 14, 2022
Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Overall Status: Active - Recruiting
Phase
1/2
Condition
Solid Tumors
Neoplasms
Treatment
N/AClinical Study ID
NCT05216965
9MW2821-2021-CP102
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Competent to comprehend, sign, and date an independent ethics committee/institutionalreview 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 (exceptsarcoma).
- 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 ofcontraception during the study and at least 6 months after termination of studytherapy.
- Subjects are willing to follow study procedures.
Exclusion
Exclusion Criteria:
- Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, orany 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 diseaseswithin 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 thefirst 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 ofdrug abuse or mental illness.
- Any P-glycoprotein (P-gp) inducers/inhibitors or CYP3A4 inducers/inhibitors within 14days prior to the first dose of study drug
- Use of any investigational drug or device within 2 months prior to the first dose ofstudy drug.
- Condition or situation which may put the subject at significant risk.
Study Design
Total Participants: 208
Study Start date:
June 11, 2022
Estimated Completion Date:
December 31, 2025
Connect with a study center
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 200032
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.