To hear about similar clinical trials, please enter your email below
Trial Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Preliminary Efficacy of 9MW3811 in Patients With Advanced Solid Tumors
NCT ID:
NCT05911984
Condition:
Advanced Malignant Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
9MW3811 Injection
Description:
Intravenous injection
Arm group label:
9MW3811 Injection
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female participants between 18 and 75 years of age, inclusive.
2. Histologically or cytologically confirmed advanced malignant solid tumors, for which
standard therapy does not exist or has proven ineffective or intolerable.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy of ≥ 3 months.
5. Participants must have measurable disease according to RECIST (version 1.1).
6. Adequate organ functions.
7. 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:
1. Participants with cancerous meningitis and/or central nervous system metastases with
clinical symptoms.
2. History of other active malignant tumor within 3 years prior to screening.
3. Suffering from poorly controlled body cavity effusion.
4. Suffering from active autoimmune disease.
5. 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.
6. History of clinically significant cardiac or cerebrovascular diseases within 6
months prior to the first dose of study drug.
7. History of other severe or uncontrolled systemic disease, i.e. poorly controlled
diabetes.
8. Previously received allogeneic hematopoietic stem cell transplantation or solid
organ transplantation.
9. Major surgery within 28 days prior to the first dose of study drug.
10. 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.
11. 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.
12. Participants who have received systemic treatment with immunosuppressants within 2
weeks prior to the first dose of study drug.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Contact:
Last name:
Xiangdong Cheng, Professor
Phone:
0571-88122222
Email:
chengxd516@126.com
Start date:
June 30, 2023
Completion date:
March 2024
Lead sponsor:
Agency:
Mabwell (Shanghai) Bioscience Co., Ltd.
Agency class:
Industry
Source:
Mabwell (Shanghai) Bioscience Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05911984
