6MW3511 in Patients With Advanced Solid Tumor

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I/II , open-label, multicenter single arm study designed to evaluate the safety, tolerability, pharmacokinetic (PK), and immunogenicity of 6MW3511.

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

Details

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

Criteria

Inclusion Criteria:

1. In dose-escalation cohorts, histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.In the dose-expansion cohorts , histologically or cytologically confirmed selected advanced solid tumors (to be determined).

2. Male or female subjects aged over 18 years old (inclusive) and not more than 80 years old (inclusive).

3. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.

Exclusion Criteria:

1. History of other malignant tumors within 3 years, except for the tumors that had been cured.

2. Symptomatic or active central nervous system metastasis.

3. Patients with active autoimmune disease.

4. History of allogeneic hematopoietic stem cell transplantation or organ transplantation.

5. Patients previously treated with PD-（L）1/ TGF-β antibody or combined PD-（L）1 with TGF-β antibody.

6. Pregnant or breast feeding.