A Clinical Study of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors
Study Details
Study Description
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, pharmacodynamics, preliminary antitumor activity and immunogenicity of 8MW2311 administered by intravenous (IV) infusion.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- AEs [Up to 28 days post last dose]
All the adverse events
- ORR [Up to 24 months]
Objective Response Rate
Secondary Outcome Measures
- BOR [Up to 24 months]
Best of Response
- DCR [Up to 24 months]
Disease Control Rate
- CBR [Up to 24 months]
Clinical Benefit Rate
- PFS [Up to 24 months]
Progression-Free Survival
- DoR [Up to 24 months]
Duration of Remission
- TTR [Up to 24 months]
Time to Response
- TTP [Up to 24 months]
Time to Progression
- OS [Up to 24 months]
Overall Survival
- PK Parameter AUC [Up to 24 months]
The area under the curve (AUC)
- PK Parameter Cmax [Up to 24 months]
Maximum concentration (Cmax)
- PK Parameter Tmax [Up to 24 months]
Time at which maximum concentration(Tmax)
- PK Parameter T1/2 [Up to 24 months]
The half life(T1/2)
- Incidence of ADA [Up to 24 months]
Incidence of Anti-Drug Antibody (ADA)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female, aged≥18 years old;
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Histologically or cytologically confirmed locally advanced or metastatic solid tumor;
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Subjects must have measurable disease according to RECIST (version 1.1)；
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Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
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Life expectancy >3 months;
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Adequate organ performance based on laboratory blood tests;
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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；
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Ability to understand and the willingness to sign a written informed consent document；
Exclusion Criteria:
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History of other malignancy within 3 years before the first dose of study drug.
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History of IL-2 or IL-2 analogues anticancer therapy.
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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.
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Major surgery within 28 days prior to first dose of study drug.
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Any live vaccines within 28 days before first dose of study drug or during the study.
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Systemic glucocorticoids or other immunosuppressants received within 14 days before first dose of study drug.
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Toxicity related to preexisting treatment ≥Grade 2.
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Central nervous system metastasis and/or cancerous meningitis.
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Inadequately controlled body cavity effusions.
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Interstitial pneumonia or interstitial lung disease, other pneumonia history or active pneumonia that may interfere with the judgement of immune-related pulmonary toxicity.
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Active autoimmune disease, or autoimmune diseases history with recurrence possibility.
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Clinically significant cardiac or cerebrovascular disease.
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Use of any investigational drug within 28 days prior to the first dose of study drug.
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Known sensitivity to any of the ingredients of the study drug.
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Known active hepatitis B or C infection, or other serious infection.
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History of drug abuse or drug addiction.
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Pregnancy or lactation.
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Other disease or condition which may put the subject at significant risk.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Mabwell (Shanghai) Bioscience Co., Ltd.
Investigators
- Principal Investigator: Jian Zhang, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 8MW2311-2022-CP101