A Clinical Study of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors
- Registration Number
- NCT05416749
- Lead Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 216
- Male or female, aged≥18 years old;
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor;
- Subjects must have measurable disease according to RECIST (version 1.1)；
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
- Life expectancy >3 months;
- Adequate organ performance based on laboratory blood tests;
- 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；
- Ability to understand and the willingness to sign a written informed consent document；
- History of other malignancy within 3 years before the first dose of study drug.
- History of IL-2 or IL-2 analogues anticancer therapy.
- 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.
- Major surgery within 28 days prior to first dose of study drug.
- Any live vaccines within 28 days before first dose of study drug or during the study.
- Systemic glucocorticoids or other immunosuppressants received within 14 days before first dose of study drug.
- Toxicity related to preexisting treatment ≥Grade 2.
- Central nervous system metastasis and/or cancerous meningitis.
- Inadequately controlled body cavity effusions.
- Interstitial pneumonia or interstitial lung disease, other pneumonia history or active pneumonia that may interfere with the judgement of immune-related pulmonary toxicity.
- Active autoimmune disease, or autoimmune diseases history with recurrence possibility.
- Clinically significant cardiac or cerebrovascular disease.
- Use of any investigational drug within 28 days prior to the first dose of study drug.
- Known sensitivity to any of the ingredients of the study drug.
- Known active hepatitis B or C infection, or other serious infection.
- History of drug abuse or drug addiction.
- Pregnancy or lactation.
- Other disease or condition which may put the subject at significant risk.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 8MW2311 8MW2311 -
- Primary Outcome Measures
Name Time Method AEs Up to 28 days post last dose All the adverse events
ORR Up to 24 months Objective Response Rate
- Secondary Outcome Measures
Name Time Method PK Parameter Tmax Up to 24 months Time at which maximum concentration(Tmax)
CBR Up to 24 months Clinical Benefit Rate
DoR Up to 24 months Duration of Remission
TTP Up to 24 months Time to Progression
TTR Up to 24 months Time to Response
BOR Up to 24 months Best of Response
OS Up to 24 months Overall Survival
PK Parameter Cmax Up to 24 months Maximum concentration (Cmax)
PFS Up to 24 months Progression-Free Survival
Incidence of ADA Up to 24 months Incidence of Anti-Drug Antibody (ADA)
DCR Up to 24 months Disease Control Rate
PK Parameter AUC Up to 24 months The area under the curve (AUC)
PK Parameter T1/2 Up to 24 months The half life(T1/2)
Trial Locations
- Locations (3)
The first affiliated hospital of bengbu medicial college
🇨🇳Bengbu, Anhui, China
Hunan cancer hospital
🇨🇳Changsha, Hunan, China
Jian Zhang
🇨🇳Shanghai, Shanghai, China