6MW3511 in Patients With Advanced Solid Tumor

Mabwell Bioscience

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Solid Tumors

Treatments: Drug: Intravenous Infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT05524194

6MW3511-2022-CP101

Details and patient eligibility

About

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

Full 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.

Enrollment: 272 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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272 participants in 1 patient group

Experimental: 6MW3511

Experimental group

Description:

Subjects will receive 6MW3511 by intravenous administration.

Treatment:

Drug: Intravenous Infusion