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Trial Title:
A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors
NCT ID:
NCT06008366
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
7MW3711 for injection
Description:
IV administration of 7MW3711, Q3W, 3 weeks a cycle
Arm group label:
Dose escalation and dose expansion
Intervention type:
Drug
Intervention name:
7MW3711 for injection
Description:
IV administration of 7MW3711, the dosage regimen including dosage and dosing frequency
for cohort expansion is conformed on basis of the data in part 1
Arm group label:
Cohort expansion
Summary:
7MW3711 is an antibody-drug conjugate(ADC) directed to a target wildly expressed on solid
tumors. This is an open-label, multicenter, phase 1/2 study to evaluate the Safety,
Tolerability, Pharmacokinetics, and Efficacy of 7MW3711 in subjects with advanced solid
tumors.
Detailed description:
Two parts are included in this study. The part of dose escalation and dose expansion(part
1) will enrolled subjects with advanced solid tumors and is to evaluate the safety and
tolerability and to determine the maximum tolerated dose and/or the recommend phase 2
dose(RP2D) of 7MW3711 in subjects with advanced solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Life expectancy of at least 3 months as assessed by the Investigator.
- Histologically or cytologically confirmed locally advanced or metastatic solid
tumor, progressive after last treatment received and who progressed on or after
standard therapies or intolerant to approved therapies or who lack of effient
standard therapies.
- An archival tumor tissue sample(formalin-fixed paraffin-embedded (FFPE) tumor tissue
block or at least 5 unstained slides) or a fresh tissue sample should be provided.
If the tissue sample cannot be provided during dose escalation, enrollment into the
study is allowed after discussion with the Investigator
- Measurable or evaluable disease by RECIST v1.1.
- Have adequate hematopoietic, renal and hepatic functions.
- Men or women willing to use adequate contraceptive measures throughout the study.
Exclusion Criteria:
- Have other prior malignancies within 3 years before the first administration.
- Known central nervous system metastatic disease or carcinomatous meningitis except
for treated and stable brain metastases.
- Have significant, uncontrolled, or active cardiovascular disease.
- Known history of COPD, or intestinal lung disease, or other respiratory diseases
requring inpatient treatments within 4 weeks prior to first administration.
- Have adverse events due to prior antitumor therapy not resolved to grade 1 or lower
by NCI CTCAE V5.0.
- Have active infections requiring treatment within 14 weeks; have infection of HIV,
active infection of HCV and HBV.
- Prior treatment with an antibody drug conjugate (ADC) that consists of an
topoisomerase I inhibitor.
- Prior treatment with B7-H3 targeted agents.
- Have received chemotherapy, immunotherapy, curative radiation within 3 weeks prior
to the first administration or targeted molecular within 2 weeks prior to first
administration. have received Chinese patent medicine or Chinese herbs of anti-tumor
indications within 1 weeks prior to the first administration.
- Have received any systemic immunosuppressants within 2 weeks prior to the first
administration except for topical corticosteroids.
- Have received any other investigational drugs or medical device within 4 weeks prior
to the first administration.
- History of drug abuse including narcotic and psychiatric drugs within 12 months
prior to screening.
- Pregnant, or nursing females.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ethics Committee of Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
剑 张, Doctor
Phone:
18017312991
Email:
syner2000@163.com
Start date:
September 5, 2023
Completion date:
February 1, 2026
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/NCT06008366
