Advanced Malignant Solid TumorPhase 1NCT05911984
A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Preliminary Efficacy of 9MW3811 in Patients With Advanced Solid Tumors
A Phase 1 study testing 9MW3811 Injection in people with Advanced Malignant Solid Tumor, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignant Solid Tumor
- What is being tested?
- 9MW3811 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2023to Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xiangdong Cheng, Professor, 0571-88122222, chengxd516@126.com
About this study
Official title: 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.
- Conditions
- Advanced Malignant Solid Tumor
- Being tested
- 9MW3811 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9MW3811 InjectionDrug
Intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| 9MW3811 Injection | Experimental | Not described Receives: Drug: 9MW3811 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) as assessed by CTCAE v5.0
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.
Measured: up to 24 weeks
Incidence of dose-limiting toxicity (DLT) as assessed by CTCAE v5.0
A DLT is defined as any of the adverse drug reactions listed in the protocol that will be assessed during Cycle 1
Measured: Cycle 1 Day 1 to Cycle 1 Day 21
Secondary outcomes (13)
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Measured: up to 24 weeks
Disease Control Rate (DCR), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Measured: up to 24 weeks
Duration of Response (DoR), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Measured: up to 24 weeks
Progression Free Survival (PFS), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Measured: up to 24 weeks
Maximum Plasma Concentration (Cmax)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Measured: up to 24 weeks
Time to reach Cmax (Tmax)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Measured: up to 24 weeks
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Measured: up to 24 weeks
Terminal elimination half-life (t1/2)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Measured: up to 24 weeks
AUC from time 0 extrapolated to infinity (AUC0-inf)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Measured: up to 24 weeks
Terminal elimination rate constant (λz)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Measured: up to 24 weeks
Apparent clearance (CL)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Measured: up to 24 weeks
Volume of distribution (Vz)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Measured: up to 24 weeks
Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline
To determine the immunogenicity of 9MW3811.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start30 Jun 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911984
- Sponsor's protocol ID
- 9MW3811-2023-CP102
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Preliminary Efficacy of 9MW3811 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05911984
- Acronym / sponsor ID
- 9MW3811-2023-CP102
- Conditions
- Advanced Malignant Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 9MW3811 Injection | Experimental | Drug: 9MW3811 Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 9MW3811 InjectionIntravenous injection | Drug | 9MW3811 Injection |
Primary outcome
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.
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
13 secondary outcomes
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
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
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
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
Maximum Plasma Concentration (Cmax)
Time frame: up to 24 weeks
Time to reach Cmax (Tmax)
Time frame: 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
Terminal elimination half-life (t1/2)
Time frame: up to 24 weeks
AUC from time 0 extrapolated to infinity (AUC0-inf)
Time frame: up to 24 weeks
Terminal elimination rate constant (λz)
Time frame: up to 24 weeks
Apparent clearance (CL)
Time frame: up to 24 weeks
Volume of distribution (Vz)
Time frame: up to 24 weeks
Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 9MW3811 Injection in people with Advanced Malignant Solid Tumor, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) as assessed by CTCAE v5.0 (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.