A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors

A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of 9MW2821 in Advanced Malignant Solid Tumors

This study is a Phase 1, 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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Malignant Solid Tumors
• Intervention / Treatment: Drug: 9MW2821

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Jun Guo, Professor; Phone Number: 13911233048; Email: guoj307@126.com
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing University Cancer Hospital
      • Principal Investigator: Jun Guo, Professor
      • Contact: Jun Guo, Professor; Phone Number: 139 1123 3048; Email: guoj307@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.
• Phase Ia：Histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma). Phase Ib：Only local advanced or metastatic UC tumors.
• Subjects must have received ICIs or GC/GP therapies in the previous treatment.
• Subjects must submit tumor tissues for test.
• 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.

Exclusion Criteria:

• Chemotherapy、radiotherapy or immunotherpy 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 ADCs 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 for high and medium effect within 14 days prior to the first dose of study drug.
• Use of any investigational drug or device within 30 days prior to the first dose of study drug.
• Conditions or situations which may put the subject at significant risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 9MW2821	Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	Up to 28 days post last drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)	Maximum observed concentration (Cmax)	24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)	Area under the concentration-time curve (AUC)	24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)	Half-life (t1/2)	24 months
Pharmacokinetic parameter：total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)	Clearance (CL)	24 months
Objective Response Rate	ORR	Up to 24 months
Disease Control Rate	DCR	Up to 24 months
Duration of Response	DoR	Up to 24 months
Time to Response	TTR	Up to 24 months
Progression Free Survival	PFS	Up to 24 months
Overall Survival	OS	Up to 24 months
Incidence of Anti-Drug Antibody (ADA)	ADA	Up to 24 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 9MW2821-2021-CP101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No