- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05911984
A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Preliminary Efficacy of 9MW3811 in Patients With Advanced Solid Tumors
June 12, 2023 updated by: Mabwell (Shanghai) Bioscience Co., Ltd.
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Preliminary Efficacy of 9MW3811 in Patients With Advanced Solid Tumors
This is a single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety, tolerability and preliminary efficacy of 9MW3811 in patients with advanced solid tumors.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
27
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310022
- Zhejiang Cancer Hospital
-
Contact:
- Xiangdong Cheng, Professor
- Phone Number: 0571-88122222
- Email: chengxd516@126.com
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female participants between 18 and 75 years of age, inclusive.
- Histologically or cytologically confirmed advanced malignant solid tumors, for which standard therapy does not exist or has proven ineffective or intolerable.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥ 3 months.
- Participants must have measurable disease according to RECIST (version 1.1).
- Adequate organ functions.
- Sexually active fertile participants, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
Exclusion Criteria:
- Participants with cancerous meningitis and/or central nervous system metastases with clinical symptoms.
- History of other active malignant tumor within 3 years prior to screening.
- Suffering from poorly controlled body cavity effusion.
- Suffering from active autoimmune disease.
- History of chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, or other respiratory diseases that require hospitalization within 4 weeks prior to the first dose of study drug.
- History of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
- History of other severe or uncontrolled systemic disease, i.e. poorly controlled diabetes.
- Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- Major surgery within 28 days prior to the first dose of study drug.
- Participants with one or more clinically significant positive test results of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, treponema pallidum antibody or human immunodeficiency virus (HIV) antibody.
- Participants who have received treatment with biotherapy, endocrine therapy, immunotherapy, or other anti-tumor therapy within 2 weeks prior to the first dose of study drug; Radical radiotherapy received within 3 weeks or palliative radiotherapy received within 2 weeks prior to the first dose of study drug; Received treatment with chemotherapy within 3 weeks prior to the first dose of study drug (6 weeks for nitrosourea or mitomycin); Received treatment with oral fluorouracil or small molecule targeted drugs within 2 weeks or 5 half-lives prior to the first dose of study drug (whichever is shorter); Received treatment with anti-tumor traditional Chinese medicine within 1 week prior to the first dose of study drug; Participated in other clinical trials within 4 weeks prior to the first dose of study drug.
- Participants who have received systemic treatment with immunosuppressants within 2 weeks prior to the first dose of study drug.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 9MW3811 Injection
|
Intravenous injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events (AEs) as assessed by CTCAE v5.0
Time Frame: up to 24 weeks
|
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
|
up to 24 weeks
|
Incidence of dose-limiting toxicity (DLT) as assessed by CTCAE v5.0
Time Frame: Cycle 1 Day 1 to Cycle 1 Day 21
|
A DLT is defined as any of the adverse drug reactions listed in the protocol that will be assessed during Cycle 1
|
Cycle 1 Day 1 to Cycle 1 Day 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators
Time Frame: up to 24 weeks
|
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
|
up to 24 weeks
|
Disease Control Rate (DCR), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators
Time Frame: up to 24 weeks
|
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
|
up to 24 weeks
|
Duration of Response (DoR), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators
Time Frame: up to 24 weeks
|
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
|
up to 24 weeks
|
Progression Free Survival (PFS), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators
Time Frame: up to 24 weeks
|
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
|
up to 24 weeks
|
Maximum Plasma Concentration (Cmax)
Time Frame: up to 24 weeks
|
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
|
up to 24 weeks
|
Time to reach Cmax (Tmax)
Time Frame: up to 24 weeks
|
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
|
up to 24 weeks
|
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
Time Frame: up to 24 weeks
|
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
|
up to 24 weeks
|
Terminal elimination half-life (t1/2)
Time Frame: up to 24 weeks
|
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
|
up to 24 weeks
|
AUC from time 0 extrapolated to infinity (AUC0-inf)
Time Frame: up to 24 weeks
|
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
|
up to 24 weeks
|
Terminal elimination rate constant (λz)
Time Frame: up to 24 weeks
|
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
|
up to 24 weeks
|
Apparent clearance (CL)
Time Frame: up to 24 weeks
|
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
|
up to 24 weeks
|
Volume of distribution (Vz)
Time Frame: up to 24 weeks
|
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
|
up to 24 weeks
|
Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline
Time Frame: up to 24 weeks
|
To determine the immunogenicity of 9MW3811.
|
up to 24 weeks
|
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 (Estimated)
June 30, 2023
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
June 12, 2023
First Submitted That Met QC Criteria
June 12, 2023
First Posted (Actual)
June 22, 2023
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 12, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9MW3811-2023-CP102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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