9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors

NCT06926998 | Not Yet Recruiting Phase 1

• 1 other identifier: 9MW2821-CP204
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecological Malignancies

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

  Up to 24 months

Secondary Outcomes (10)

• DoR

  Up to 24 months

• TTR

  Up to 24 months

• DCR

  Up to 24 months

• PFS

  Up to 24 months

• OS

  Up to 24 months

Study Arms (1)

Treatment Cohort

EXPERIMENTAL

9MW2821+ other anti-cancer therapy

Drug: 9MW2821+other anticancer therapy

Interventions

9MW2821+other anticancer therapy DRUG

Subjects will receive intravenous (IV) infusion of 9MW2821 +other anticancer therapy as per protocol

Treatment Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Study Officials

• Hanmei Lou, Professor

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanmei Lou, Professor

CONTACT

13355783145; louhm@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 15, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)