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Trial Title:
A Study of 7MW3711 in Subjects With Advanced Solid Tumors
NCT ID:
NCT06008379
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 a antibody-drug conjugate(ADC) drected 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 pahse 2
dose(RP2D) of 7MW3711 in subjects with advanced solid tumors.
The part of cohort expansion(part 2) will enrolled subejcts with selected advanced solid
tumors and is to assess the preliminary efficacy of 7MW3711 in selected 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.
- Part 1: 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; part 2: Histologically or cytologically confirmed locally
advanced or metastatic selected advanced solid tumors having progressed after at
least one line of standard systermic therapy or intolerate 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:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Qiming Wang
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yongzhong Luo
Facility:
Name:
Xuzhou Central Hospital
Address:
City:
Xuzhou
Zip:
221009
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Liang Han
Facility:
Name:
The Lung Cancer Center of Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
2000043
Country:
China
Status:
Recruiting
Contact:
Last name:
Sun Lu, Doctor
Phone:
021-22200000*3121
Email:
shun-lu@hotmail.com
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhengbo Song, Doctor
Email:
songzb@zjcc.org.cn
Start date:
August 28, 2023
Completion date:
January 30, 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/NCT06008379
