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

A Phase Ib/ll Clinical Study of Safety and Efficacy of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: 9MW2821; Drug: Other anti-cancer therapy

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Feng Wang; Phone Number: 13938244776; Email: fengw010@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 451161
      • The First Affiliated Hospital of Zhengzhou University
      • Principal Investigator: Feng Wang
      • Contact: Feng Wang; Phone Number: 13938244776; Email: fengw010@163.com

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. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AE/SAE (phase Ib)	Adverse event (AE), serious adverse event (SAE)	Up to approximately 24 months
Objective Response Rate, ORR (phase II)	The proportion of participants with complete response (CR) or partial response (PR)	Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response, DOR	Time from the date of the first CR or PR to the earliest date of disease progression or death	Up to approximately 24 months
Time To Response, TTR	Time from the date of first infusion to the date of CR or PR	Up to approximately 24 months
Disease Control Rate, DCR	The percentage of subjects who experience CR, PR or stable disease (SD)	Up to approximately 24 months
Progression-Free Survival, PFS	Time from the date of first infusion to the earliest date of disease progression or death	Up to approximately 24 months
Overall Survival, OS	Time from the date of first infusion to the date of death	Up to approximately 24 months
Pharmacokinetics parameter, Tmax	Peak time	Up to approximately 24 months
Pharmacokinetics parameter, Cmax	Maximum concentration	Up to approximately 24 months
Pharmacokinetics parameter, AUC	Area under the concentration-time curve	Up to approximately 24 months
Pharmacokinetics parameter, t1/2	Half-life	Up to approximately 24 months
Pharmacokinetics parameter, V	Apparent volume of distribution	Up to approximately 24 months
Pharmacokinetics parameter, CL	Clearance	Up to approximately 24 months
Immunogenicity parameter	Anti-Drug Antibody (ADA) of 9MW2821	Up to approximately 24 months

Collaborators and Investigators

• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
• Investigators: Principal Investigator: Feng Wang, The First Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 21, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 9MW2821-CP201

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