A Clinical Study of 6MW3211 Injection in the Treatment of Advanced Malignant Neoplasm

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a single arm, non-randomized, open label, multiple doses phase I/II international, multicenter clinical trial to evaluate safety, tolerability, PK/PD, immunogenicity and preliminary efficacy in subjects with advanced malignant neoplasm. The study is consisted of two stages: dose escalation and clinical expansion.

Only Phase I has been submitted to US FDA,and the protocol number is still the same as 6MW3211-2021-CP101.The US title is : A Phase 1, First-in-Human (FIH), Multicenter, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 6MW3211 in Patients with Advanced Malignancies .

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Criteria

Inclusion Criteria:

• 1. Men or women, age ≥18.

• 2.Subjects with advanced malignancy histopathologically and/or cytologically, with at least one evaluable tumor lesion.

• 3.ECOG PS is 0 or 1.

• 4.Survival expectation of at least 3 months.

• 5.Adequate organs and hematopoietic functions

• 6.Voluntarily signing of informed consent

Exclusion Criteria:

• 1.Subjects with brain metastases of clinically active central nervous system (CNS).

• 2.Subjects that require to take anticoagulants and/or aspirin.

• 3.Blood transfusion within 2 weeks prior to the first administration of study treatment.

• 4.Inadequately controlled body cavity effusions.

• 5.Subjects with active, or have a history and possible recurrence of autoimmune diseases .

• 6.Have uncontrolled systemic diseases.

• 7.Subjects who had received anticancer therapy or radiotherapy within 4 weeks or 5 half-lives (whichever is shorter) before enrollment.

• 8.Subjects are known to have previously experienced severe allergic reactions to large molecular protein formulations/monoclonal antibodies.

• 9.Pregnant or lactating women.