Clinical trial NCT06926998: 9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Gynecological Malignancies
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-15
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: ORR
timeFrame: Up to 24 months
Secondary outcomes:
measure: DoR
timeFrame: Up to 24 months
measure: TTR
timeFrame: Up to 24 months
measure: DCR
timeFrame: Up to 24 months
measure: PFS
timeFrame: Up to 24 months
measure: OS
timeFrame: Up to 24 months
measure: Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
timeFrame: 24 months
measure: Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
timeFrame: 24 months
measure: Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
timeFrame: 24 months
measure: Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
timeFrame: 24 months
measure: Incidence of Anti-Drug Antibody (ADA)
timeFrame: 24 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Hanmei Lou, Professor
role: PRINCIPAL_INVESTIGATOR
References: