Solid Tumors
Conditions
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.
Interventions
DRUGIntravenous 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).
Sponsors
Mabwell (Shanghai) Bioscience Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Outcome results
None listed