6MW3511 in Patients With Advanced Solid Tumor

Phase 1

Not yet recruiting

• Conditions: Solid Tumors
• Interventions: Drug: Intravenous Infusion

• Registration Number: NCT05524194
• Lead Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

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.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-28
• Study First Submitted QC: 2022-08-31
• Last Update Submitted: 2022-08-31
• Study First Posted: 2022-09-01
• Last Update Posted: 2022-09-01
• Study Start: 2022-10
• Primary Completion: 2024-06
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 272

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: 6MW3511	Intravenous Infusion	Subjects will receive 6MW3511 by intravenous administration.

Primary Outcome Measures

Name	Time	Method
Number of participants with a Dose Limiting Toxicity (DLT)	Up to Week 3	DLTs will be assessed during the first 3 weeks of treatment for dose-escalation phase.
Number of participants with adverse events (AEs)	Up to 4 weeks after last treatment	Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs.

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Up to 2 years	The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Disease control rate (DCR)	Up to 2 years	The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.
Maximum observed concentration (Cmax) of 6MW3511	Up to 4 weeks after last treatment	The endpoints for assessment of PK of 6MW3511 include serum concentrations of 6MW3511 at different timepoints after administration.
Number of subjects who develop detectable anti-drug antibodies (ADAs)	Up to 4 weeks after last treatment	The immunogenicity of 6MW3511 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).