6MW3511 in Patients With Advanced Solid Tumor

NCT ID: NCT05524194

Last Updated: 2022-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2024-09-30

Brief 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.

Detailed Description

This is a Phase I/II, open-label, dose-escalation trial with consecutive parallel-group expansion in selected solid tumor indications. The study consists of a dose escalation phase to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for 6MW3511, and a dose expansion phase which will characterize treatment of 6MW3511 at the RP2D.

Conditions

Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: 6MW3511

Subjects will receive 6MW3511 by intravenous administration.

Group Type: EXPERIMENTAL

Intravenous Infusion

Intervention Type: DRUG

Dose-limiting toxicity (DLT) are assessed during the first 3 weeks (21 days) after initial administration. Then, the intended dosing frequency is every 2 weeks (Q2W).

Interventions

Intravenous Infusion

Dose-limiting toxicity (DLT) are assessed during the first 3 weeks (21 days) after initial administration. Then, the intended dosing frequency is every 2 weeks (Q2W).

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mabwell (Shanghai) Bioscience Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

6MW3511-2022-CP101

Identifier Type: -

Identifier Source: org_study_id