- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05524194
6MW3511 in Patients With Advanced Solid Tumor
August 31, 2022 updated by: Mabwell (Shanghai) Bioscience Co., Ltd.
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
This is a phase I/II , open-label, multicenter single arm study designed to evaluate the safety, tolerability, pharmacokinetic (PK), and immunogenicity of 6MW3511.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
272
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental: 6MW3511
Subjects will receive 6MW3511 by intravenous administration.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to Week 3
|
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.
|
Up to 4 weeks after last treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: 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.
|
Up to 2 years
|
Disease control rate (DCR)
Time Frame: 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.
|
Up to 2 years
|
Maximum observed concentration (Cmax) of 6MW3511
Time Frame: 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.
|
Up to 4 weeks after last treatment
|
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time Frame: 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).
|
Up to 4 weeks after last treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
October 1, 2022
Primary Completion (ANTICIPATED)
June 1, 2024
Study Completion (ANTICIPATED)
September 1, 2024
Study Registration Dates
First Submitted
August 28, 2022
First Submitted That Met QC Criteria
August 31, 2022
First Posted (ACTUAL)
September 1, 2022
Study Record Updates
Last Update Posted (ACTUAL)
September 1, 2022
Last Update Submitted That Met QC Criteria
August 31, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6MW3511-2022-CP101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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