Status:
SUSPENDED
A Clinical Study of 8MW2311 in Subjects With Locally Advanced or Metastatic Solid Tumors
Lead Sponsor:
Mabwell (Shanghai) Bioscience Co., Ltd.
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ant...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT05416749
Start Date
August 5 2022
End Date
March 1 2026
Last Update
November 20 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
The first affiliated hospital of bengbu medicial college
Bengbu, Anhui, China
2
Hunan cancer hospital
Changsha, Hunan, China
3
Jian Zhang
Shanghai, Shanghai Municipality, China