6MW3511 in Patients With Advanced Solid Tumor

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase I/II, Multicenter, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamics of 6MW3511 in Patients With Advanced Solid Tumor

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: Intravenous Infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Male or female subjects aged over 18 years old (inclusive) and not more than 80 years old (inclusive). Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1. Exclusion Criteria: History of other malignant tumors within 3 years, except for the tumors that had been cured. Symptomatic or active central nervous system metastasis. Patients with active autoimmune disease. History of allogeneic hematopoietic stem cell transplantation or organ transplantation. Patients previously treated with PD-（L）1/ TGF-β antibody or combined PD-（L）1 with TGF-β antibody. Pregnant or breast feeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: 6MW3511<br>Subjects will receive 6MW3511 by intravenous administration. | Drug: Intravenous Infusion<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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