A Clinical Study of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors

Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Antitumor Activity of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors

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, pharmacodynamics, preliminary antitumor activity and immunogenicity of 8MW2311 administered by intravenous (IV) infusion.

Study Overview

• Status: Suspended
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: 8MW2311

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • The first affiliated hospital of bengbu medicial college
  • Hunan
    • Changsha, Hunan, China
      • Hunan Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Jian Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female, aged≥18 years old;
2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor;
3. Subjects must have measurable disease according to RECIST (version 1.1)；
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
5. Life expectancy >3 months;
6. Adequate organ performance based on laboratory blood tests;
7. 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；
8. Ability to understand and the willingness to sign a written informed consent document；

Exclusion Criteria:

1. History of other malignancy within 3 years before the first dose of study drug.
2. History of IL-2 or IL-2 analogues anticancer therapy.
3. 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.
4. Major surgery within 28 days prior to first dose of study drug.
5. Any live vaccines within 28 days before first dose of study drug or during the study.
6. Systemic glucocorticoids or other immunosuppressants received within 14 days before first dose of study drug.
7. Toxicity related to preexisting treatment ≥Grade 2.
8. Central nervous system metastasis and/or cancerous meningitis.
9. Inadequately controlled body cavity effusions.
10. Interstitial pneumonia or interstitial lung disease, other pneumonia history or active pneumonia that may interfere with the judgement of immune-related pulmonary toxicity.
11. Active autoimmune disease, or autoimmune diseases history with recurrence possibility.
12. Clinically significant cardiac or cerebrovascular disease.
13. Use of any investigational drug within 28 days prior to the first dose of study drug.
14. Known sensitivity to any of the ingredients of the study drug.
15. Known active hepatitis B or C infection, or other serious infection.
16. History of drug abuse or drug addiction.
17. Pregnancy or lactation.
18. Other disease or condition 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: 8MW2311	Drug: 8MW2311; All subjects will receive a single intravenous (IV) infusion of 8MW2311 every 21 days (q21d), other dosing frequencies may be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective Response Rate	Up to 24 months
AEs	All the adverse events	Up to 28 days post last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BOR	Best of Response	Up to 24 months
DCR	Disease Control Rate	Up to 24 months
CBR	Clinical Benefit Rate	Up to 24 months
PFS	Progression-Free Survival	Up to 24 months
DoR	Duration of Remission	Up to 24 months
TTR	Time to Response	Up to 24 months
TTP	Time to Progression	Up to 24 months
OS	Overall Survival	Up to 24 months
PK Parameter AUC	The area under the curve (AUC)	Up to 24 months
PK Parameter Cmax	Maximum concentration (Cmax)	Up to 24 months
PK Parameter Tmax	Time at which maximum concentration(Tmax)	Up to 24 months
PK Parameter T1/2	The half life(T1/2)	Up to 24 months
Incidence of ADA	Incidence of Anti-Drug Antibody (ADA)	Up to 24 months

Collaborators and Investigators

• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
• Investigators: Principal Investigator: Jian Zhang, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2022
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 8MW2311-2022-CP101

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