A Clinical Study of 9MW2821 in Subjects With Advanced Malignant Solid Tumors

NCT ID: NCT05216965

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-11
• Study Completion Date: 2025-12-31

Brief Summary

This study is a Phase 1/2, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9MW2821 administered by intravenous (IV) infusion.

Conditions

Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

9MW2821

Group Type: EXPERIMENTAL

9MW2821

Intervention Type: DRUG

All subjects will receive a single intravenous (IV) infusion of 9MW2821 once weekly for the first 3 weeks of every 4 week cycle (i.e., on Days 1, 8 and 15).

Interventions

9MW2821

All subjects will receive a single intravenous (IV) infusion of 9MW2821 once weekly for the first 3 weeks of every 4 week cycle (i.e., on Days 1, 8 and 15).

Intervention Type: DRUG

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. Male or female subjects aged 18 to 80 years (including 18 and 80 years).

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

4. Histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma).

5. For Cohort Expansion: Subjects must submit tumor tissue for Nectin-4 expression.

6. Life expectancy of ≥ 3 months.

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 methods of 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. Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, or any other anticancer therapy within 14 days prior to the first dose of study drug.

2. Preexisting treatment related toxicity Grade ≥ 2 (except alopecia).

3. Major surgery within 28 days prior to first dose of study drug.

4. History of uncontrolled diabetes mellitus.

5. Preexisting peripheral neuropathy Grade ≥ 2.

6. Received treatment of nectin-4 targeted ADC with MMAE payload.

7. Any live vaccines within 4 weeks before first dose of study drug or during the study.

8. Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.

9. Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.

10. Uncontrolled central nervous system metastases.

11. History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.

12. History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.

13. Has ocular conditions that may increase the risk of corneal epithelium damage.

14. Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.

15. Any P-glycoprotein (P-gp) inducers/inhibitors or CYP3A4 inducers/inhibitors within 14 days prior to the first dose of study drug

16. Use of any investigational drug or device within 2 months prior to the first dose of study drug.

17. Condition or situation which may put the subject at significant risk.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mabwell (Shanghai) Bioscience Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jian Zhang, Professor

Role: primary

syner2000@163.com

13918273761

References

Zhang J, Liu R, Wang S, Feng Z, Yang H, Gao S, Li X, Yao X, Chen J, Gong Z, Li Y, Li X, Wang S, Hu C, Liu J, Zhang M, Yuan F, Shi B, Lou H, Zhao P, Qiu F, Guo H, Hu B, Xu D, Huang H, Zhang X, Feng M, Wang X, Li G, Liu D, Chen X, Wang P. Bulumtatug Fuvedotin (BFv, 9MW2821), a next-generation Nectin-4 targeting antibody-drug conjugate, in patients with advanced solid tumors: a first-in-human, open-label, multicenter, phase I/II study. Ann Oncol. 2025 Aug;36(8):934-943. doi: 10.1016/j.annonc.2025.04.009. Epub 2025 Apr 25.

Reference Type: DERIVED

PMID: 40288679 (View on PubMed)

Other Identifiers

9MW2821-2021-CP102

Identifier Type: -

Identifier Source: org_study_id