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

NCT05216965 | Unknown Phase 1

• 1 other identifier: 9MW2821-2021-CP102
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  Up to 28 days post last drug administration

• Objective Response Rate (Phase 2)

  Defined as the percentage of subjects who experience a best response of either CR or PR. CR and PR must be confirmed ≥ 28 days later.

  Up to 24 months

Secondary Outcomes (10)

• Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)

  24 months

• Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)

  24 months

• Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)

  24 months

• Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)

  24 months

• Disease Control Rate

  Up to 24 months

Study Arms (1)

9MW2821

EXPERIMENTAL

Drug: 9MW2821

Interventions

9MW2821 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).

9MW2821

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
• Male or female subjects aged 18 to 80 years (including 18 and 80 years).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma).
• For Cohort Expansion: Subjects must submit tumor tissue for Nectin-4 expression.
• Life expectancy of ≥ 3 months.
• Subjects must have measurable disease according to RECIST (version 1.1).
• Adequate organ functions.
• 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.
• Subjects are willing to follow study procedures.

You may not qualify if:

• 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.
• Preexisting treatment related toxicity Grade ≥ 2 (except alopecia).
• Major surgery within 28 days prior to first dose of study drug.
• History of uncontrolled diabetes mellitus.
• Preexisting peripheral neuropathy Grade ≥ 2.
• Received treatment of nectin-4 targeted ADC with MMAE payload.
• Any live vaccines within 4 weeks before first dose of study drug or during the study.
• Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
• Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.
• Uncontrolled central nervous system metastases.
• History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.
• History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.
• Has ocular conditions that may increase the risk of corneal epithelium damage.
• Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
• Any P-glycoprotein (P-gp) inducers/inhibitors or CYP3A4 inducers/inhibitors within 14 days prior to the first dose of study drug

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40288679 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 1, 2022
• Study Start: June 11, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)