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
Overview
- Phase
- Phase 1
- Intervention
- Intravenous Infusion
- Conditions
- Solid Tumors
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Enrollment
- 272
- Primary Endpoint
- Number of participants with a Dose Limiting Toxicity (DLT)
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Experimental: 6MW3511
Subjects will receive 6MW3511 by intravenous administration.
Intervention: Intravenous Infusion
Outcomes
Primary Outcomes
Number of participants with a Dose Limiting Toxicity (DLT)
Time Frame: 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)
Time Frame: Up to 4 weeks after last treatment
Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs.
Secondary Outcomes
- Objective response rate (ORR)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Maximum observed concentration (Cmax) of 6MW3511(Up to 4 weeks after last treatment)
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(Up to 4 weeks after last treatment)