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

An Open-Label, Multicenter Phase Ib/ll Clinical Study Evaluating the Safety and Efficacy of 9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors

To evaluate the safety, tolerability, and preliminary efficacy of 9MW2821 in combination with other anti-tumor agents in patients with advanced gynecological malignancies.

Study Overview

• Status: Not yet recruiting
• Conditions: Gynecological Malignancies
• Intervention / Treatment: Drug: 9MW2821+other anticancer therapy

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Hanmei Lou, Professor; Phone Number: 13355783145; Email: louhm@zjcc.org.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
      • Contact: Hanmei Lou; Phone Number: 13355783145; Email: louhm@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
2. Female subjects aged 18 to 75 years (including 18 and 75 years).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histopathological diagnosed of advanced gynecological tumors.
5. Subjects must submit tumor tissues for test.
6. Life expectancy of ≥ 12 weeks.
7. Subjects must have measurable disease according to RECIST (version 1.1).
8. Adequate organ functions.
9. Sexually active fertile subjects must agree to use methods of contraception during the study and at least 180 days after termination of study therapy.
10. Subjects are willing to follow study procedures.

Exclusion Criteria:

1. History of another malignancy within 3 years before the first dose of study drug.
2. Patients with ongoing clinically significant toxicities related to prior treatment.
3. Presence of Grade ≥ 2 peripheral neuropathy.
4. Exclusion of prior diseases and prior treatments as specified in the protocol.
5. 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.
6. Clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to the first dose of medication.
7. Subjects with central nervous system (CNS) metastases and/or carcinomatous meningitis.
8. Pleural, peritoneal, or pericardial effusion with clinical symptoms or requiring repeated drainage procedures.
9. 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;.
10. 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.
11. Pregnant or lactating women.
12. Not suitable to receive study treatment for other conditions as per investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Cohort; 9MW2821+ other anti-cancer therapy	Drug: 9MW2821+other anticancer therapy; Subjects will receive intravenous (IV) infusion of 9MW2821 +other anticancer therapy as per protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective Response Rate	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DCR	Disease Control Rate	Up to 24 months
TTR	Time to Response	Up to 24 months
OS	Overall Survival	Up to 24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)	Maximum observed concentration (Cmax)	24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)	Area under the concentration-time curve (AUC)	24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)	Half-life (t1/2)	24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)	Clearance (CL)	24 months
DoR	Duration of Response	Up to 24 months
PFS	Progression Free Survival	Up to 24 months
Incidence of Anti-Drug Antibody (ADA)	ADA	24 months

Collaborators and Investigators

• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
• Investigators: Principal Investigator: Hanmei Lou, Professor, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 9MW2821-CP204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No