Status:
NOT_YET_RECRUITING
9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors
Lead Sponsor:
Mabwell (Shanghai) Bioscience Co., Ltd.
Conditions:
Gynecological Malignancies
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
To evaluate the safety, tolerability, and preliminary efficacy of 9MW2821 in combination with other anti-tumor agents in patients with advanced gynecological malignancies.
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.
- 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 advanced gynecological tumors.
- Subjects must submit tumor tissues 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 must agree to use methods of contraception during the study and at least 180 days 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.
- Patients with ongoing clinically significant toxicities related to prior treatment.
- Presence of Grade ≥ 2 peripheral neuropathy.
- Exclusion of prior diseases and prior treatments as specified in the protocol.
- Comorbidities: a. Hemoglobin A1C ≥ 8%; b. Ocular diseases or symptoms present prior to the first dose of study medication; c. Severe respiratory diseases; d. Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study medication; e. Active autoimmune diseases within 2 years prior to the first dose of study medication, or a history of autoimmune diseases with potential for recurrence; f. Active infections; g. Severe arterial or venous thromboembolic events.
- Clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to the first dose of medication.
- Subjects with central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Pleural, peritoneal, or pericardial effusion with clinical symptoms or requiring repeated drainage procedures.
- Prior Treatments: a. Major surgical procedures within 28 days prior to the first dose of study medication; b. Administration of other investigational drugs or experimental medical devices within 28 days prior to the first dose of study medication; c. Use of P-glycoprotein inhibitors or inducers, or potent CYP3A4 inhibitors within 14 days prior to the first dose of study medication; d. Receipt of live vaccines within 28 days prior to the first dose of study medication or planned administration of any live vaccine during the study period; e. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;.
- Subjects with a history of drug abuse or psychiatric disorders, or suspected allergy, intolerance, or severe infusion reactions to the investigational drug or any of its components.
- Pregnant or lactating women.
- Not suitable to receive study treatment for other conditions as per investigator.
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT06926998
Start Date
April 15 2025
End Date
May 1 2027
Last Update
April 15 2025
Active Locations (1)
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1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022