A Clinical Study of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors

NCT ID: NCT06947226

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combination Cohort

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

Group Type EXPERIMENTAL

9MW2821

Intervention Type DRUG

Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol

Other anti-cancer therapy

Intervention Type DRUG

Subjects will receive other anticancer therapy as per protocol

Single agent Cohort

Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol

Group Type EXPERIMENTAL

9MW2821

Intervention Type DRUG

Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol

Interventions

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9MW2821

Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol

Intervention Type DRUG

Other anti-cancer therapy

Subjects will receive other anticancer therapy as per protocol

Intervention Type DRUG

Eligibility Criteria

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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. Male or 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 recurrent or locally advanced or metastatic solid tumors.
5. Adequate tumor tissues submitted 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, and their partners, must agree to use contraception during the study and at least 6 months 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. Ongoing clinically significant toxicities related to prior treatment.
3. Grade ≥ 2 peripheral neuropathy.
4. Severe or uncontrolled gastrointestinal diseases.
5. Other severe or uncontrolled diseases, including severe respiratory diseases, cardiovascular and cerebrovascular diseases of clinical significance.
6. Experienced clinically significant bleeding or had a clear bleeding tendency.
7. Central nervous system (CNS) metastasis and/or malignant meningitis.
8. Clinically significant pleural, abdominal, or pericardial effusion.
9. Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug;
10. Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
11. Pregnant and lactating women.
12. Other conditions that, in the Investigator's opinion, may not be suitable for the subject to be enrolled.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mabwell (Shanghai) Bioscience Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Feng Wang

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Locations

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The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Countries

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China

Central Contacts

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Feng Wang

Role: CONTACT

13938244776

Facility Contacts

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Feng Wang

Role: primary

13938244776

Other Identifiers

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9MW2821-CP201

Identifier Type: -

Identifier Source: org_study_id

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