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

Phase 1

Not yet recruiting

• Conditions: Solid Tumors
• Interventions: Drug: 9MW2821; Drug: Other anti-cancer therapy

• Registration Number: NCT06947226
• Lead Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted: 2025-04-21
• Study First Submitted QC: 2025-04-21
• Last Update Submitted: 2025-04-21
• Study First Posted: 2025-04-27
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 188

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combination Cohort	9MW2821	Subjects will receive intravenous (IV) infusion of 9MW2821 + other anticancer therapy as per protocol
Combination Cohort	Other anti-cancer therapy	Subjects will receive intravenous (IV) infusion of 9MW2821 + other anticancer therapy as per protocol
Single agent Cohort	9MW2821	Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China