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Trial Title:
6MW3511 in Patients With Advanced Solid Tumor
NCT ID:
NCT05524194
Condition:
Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Intravenous Infusion
Description:
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).
Arm group label:
Experimental: 6MW3511
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
October 2022
Completion date:
September 2024
Lead sponsor:
Agency:
Mabwell (Shanghai) Bioscience Co., Ltd.
Agency class:
Industry
Source:
Mabwell (Shanghai) Bioscience Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05524194
