A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Preliminary Efficacy of 9MW3811 in Patients With Advanced Solid Tumors
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 9MW3811 Injection
|
Drug: 9MW3811 Injection
Intravenous injection
|
Outcome Measures
Primary Outcome Measures
- Incidence of adverse events (AEs) as assessed by CTCAE v5.0 [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.
- Incidence of dose-limiting toxicity (DLT) as assessed by CTCAE v5.0 [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
Secondary Outcome Measures
- Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators [up to 24 weeks]
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
- Disease Control Rate (DCR), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators [up to 24 weeks]
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
- Duration of Response (DoR), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators [up to 24 weeks]
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
- Progression Free Survival (PFS), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators [up to 24 weeks]
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
- Maximum Plasma Concentration (Cmax) [up to 24 weeks]
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
- Time to reach Cmax (Tmax) [up to 24 weeks]
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
- Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) [up to 24 weeks]
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
- Terminal elimination half-life (t1/2) [up to 24 weeks]
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
- AUC from time 0 extrapolated to infinity (AUC0-inf) [up to 24 weeks]
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
- Terminal elimination rate constant (λz) [up to 24 weeks]
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
- Apparent clearance (CL) [up to 24 weeks]
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
- Volume of distribution (Vz) [up to 24 weeks]
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
- Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline [up to 24 weeks]
To determine the immunogenicity of 9MW3811.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female participants between 18 and 75 years of age, inclusive.
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Histologically or cytologically confirmed advanced malignant solid tumors, for which standard therapy does not exist or has proven ineffective or intolerable.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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Life expectancy of ≥ 3 months.
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Participants must have measurable disease according to RECIST (version 1.1).
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Adequate organ functions.
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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:
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Participants with cancerous meningitis and/or central nervous system metastases with clinical symptoms.
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History of other active malignant tumor within 3 years prior to screening.
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Suffering from poorly controlled body cavity effusion.
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Suffering from active autoimmune disease.
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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.
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History of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
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History of other severe or uncontrolled systemic disease, i.e. poorly controlled diabetes.
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Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
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Major surgery within 28 days prior to the first dose of study drug.
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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.
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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.
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Participants who have received systemic treatment with immunosuppressants within 2 weeks prior to the first dose of study drug.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China | 310022 |
Sponsors and Collaborators
- Mabwell (Shanghai) Bioscience Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 9MW3811-2023-CP102