Not yet recruitingNCT05911984Updated Jun 22, 2023

A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Preliminary Efficacy of 9MW3811 in Patients With Advanced Solid Tumors

A Phase 1 interventional study of 9MW3811 Injection in Advanced Malignant Solid Tumor, sponsored by Mabwell (Shanghai) Bioscience Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Mabwell (Shanghai) Bioscience Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Mar 2024, 2 years 7 months ago, but the record still lists the study as not yet recruiting.

Phase: Phase 1
Study type: Interventional
Enrollment: 27
Allocation: Not applicable
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Conditions studied

Advanced Malignant Solid Tumor

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Neoplasms 9,365

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 27 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Mabwell (Shanghai) Bioscience Co., Ltd. is the lead sponsor of 53 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 27 participants (estimated)

Study arms

Experimental
9MW3811 Injection
Drug: 9MW3811 Injection

Interventions

Drug9MW3811 Injection
Intravenous injection

What researchers measure

Primary outcomes

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.
Time frame: 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
Time frame: Cycle 1 Day 1 to Cycle 1 Day 21

Secondary outcomes

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.
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
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
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
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
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
To determine the preliminary efficacy of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Time frame: 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.
Time frame: 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.
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)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in patients with advanced solid tumors.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 24 weeks
Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline
To determine the immunogenicity of 9MW3811.
Time frame: up to 24 weeks

Study locations

1 site

Zhejiang Cancer Hospital
Hangzhou, Zhejiang 310022, China
- Xiangdong Cheng, Professor · Contact · chengxd516@126.com · 0571-88122222

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05911984
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Responsible party: Sponsor
First posted: Jun 22, 2023
Start date: Jun 30, 2023 (estimated)
Primary completion: Mar 2024 (estimated)
Completion: Mar 2024 (estimated)
Last update: Jun 22, 2023

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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