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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: 8MW2311


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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； Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 8MW2311<br> | Drug: 8MW2311<br>* All subjects will receive a single intravenous (IV) infusion of 8MW2311 every 21 days (q21d), other dosing frequencies may be used.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

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 |