Status:
NOT_YET_RECRUITING
A Clinical Study of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors
Lead Sponsor:
Mabwell (Shanghai) Bioscience Co., Ltd.
Conditions:
Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is a Phase Ib/ll, open-label, multicenter study designed to evaluate the safety and efficacy of 9MW2821 monotherapy or combined with other anticancer therapy in advanced solid tumors.
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 75 years (including 18 and 75 years).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histopathological diagnosed of recurrent or locally advanced or metastatic solid tumors.
- Adequate tumor tissues submitted for test.
- Life expectancy of ≥ 12 weeks.
- 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 contraception during the study and at least 6 months after termination of study therapy.
- Subjects are willing to follow study procedures.
Exclusion
- History of another malignancy within 3 years before the first dose of study drug.
- Ongoing clinically significant toxicities related to prior treatment.
- Grade ≥ 2 peripheral neuropathy.
- Severe or uncontrolled gastrointestinal diseases.
- Other severe or uncontrolled diseases, including severe respiratory diseases, cardiovascular and cerebrovascular diseases of clinical significance.
- Experienced clinically significant bleeding or had a clear bleeding tendency.
- Central nervous system (CNS) metastasis and/or malignant meningitis.
- Clinically significant pleural, abdominal, or pericardial effusion.
- Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug;
- Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
- Pregnant and lactating women.
- Other conditions that, in the Investigator's opinion, may not be suitable for the subject to be enrolled.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT06947226
Start Date
April 1 2025
End Date
April 1 2027
Last Update
April 27 2025
Active Locations (1)
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1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 451161