A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors

NCT ID: NCT06008366

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 281 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-05
• Study Completion Date: 2026-02-01

Brief 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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose escalation and dose expansion

All subjects enrolled in the part of dose escalation and dose expansion will receive 7MW3711 by introvenous infusion

Group Type: EXPERIMENTAL

7MW3711 for injection

Intervention Type: DRUG

IV administration of 7MW3711, Q3W, 3 weeks a cycle

Cohort expansion

All subjects enrolled in the part of cohort expansion will be treated by 7MW3711 will receive 7MW3711 by introvenous infusion

Group Type: EXPERIMENTAL

7MW3711 for injection

Intervention Type: DRUG

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

Interventions

7MW3711 for injection

IV administration of 7MW3711, Q3W, 3 weeks a cycle

Intervention Type: DRUG

7MW3711 for injection

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mabwell (Shanghai) Bioscience Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ethics Committee of Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian Zhang, Ph.D

Role: CONTACT

syner2000@163.com

18017312991

Facility Contacts

剑 张, Doctor

Role: primary

syner2000@163.com

18017312991

Other Identifiers

7MW3711-2023-CP101

Identifier Type: -

Identifier Source: org_study_id