A Clinical Study of 6MW3211 Injection in the Treatment of Advanced Malignant Neoplasm

NCT ID: NCT05048160

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-27
• Study Completion Date: 2024-12-31

Brief Summary

This study is a single arm, non-randomized, open label, multiple doses phase I/II international, multicenter clinical trial to evaluate safety, tolerability, PK/PD, immunogenicity and preliminary efficacy in subjects with advanced malignant neoplasm. The study is consisted of two stages: dose escalation and clinical expansion.

Only Phase I has been submitted to US FDA,and the protocol number is still the same as 6MW3211-2021-CP101.The US title is : A Phase 1, First-in-Human (FIH), Multicenter, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 6MW3211 in Patients with Advanced Malignancies .

Detailed Description

Six cohorts are included in dose escalation stage, at doses of 0.3~45 mg/kg, respectively. Safety, tolerability, and dose-limiting toxicity (DLT) are assessed during the first 3 weeks (21 days) after initial administration. Then, the intended dosing frequency is every 2 weeks (Q2W), IV.

From the first study drug administration, some dosing cycles will be observed for phase I, initial tumor efficacy assessments will be performed at week 7, after that tumor efficacy assessment will be carry out for every 6 weeks.

Conditions

Advanced Malignant Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

6MW3211

• Dosage form: injection
• Specification: 240 mg / 8 ml/Vial

Group Type: EXPERIMENTAL

Intravenous Infusion

Intervention Type: DRUG

Dose-limiting toxicity (DLT) are assessed during the first 3 weeks (21 days) after initial administration. Then, the intended dosing frequency is every 2 weeks (Q2W).

Interventions

Intravenous Infusion

Dose-limiting toxicity (DLT) are assessed during the first 3 weeks (21 days) after initial administration. Then, the intended dosing frequency is every 2 weeks (Q2W).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1. Men or women, age ≥18.
• 2.Subjects with advanced malignancy histopathologically and/or cytologically, with at least one evaluable tumor lesion.
• 3.ECOG PS is 0 or 1.
• 4.Survival expectation of at least 3 months.
• 5.Adequate organs and hematopoietic functions
• 6.Voluntarily signing of informed consent

Exclusion Criteria

• 1.Subjects with brain metastases of clinically active central nervous system (CNS).
• 2.Subjects that require to take anticoagulants and/or aspirin.
• 3.Blood transfusion within 2 weeks prior to the first administration of study treatment.
• 4.Inadequately controlled body cavity effusions.
• 5.Subjects with active, or have a history and possible recurrence of autoimmune diseases .
• 6.Have uncontrolled systemic diseases.
• 7.Subjects who had received anticancer therapy or radiotherapy within 4 weeks or 5 half-lives (whichever is shorter) before enrollment.
• 8.Subjects are known to have previously experienced severe allergic reactions to large molecular protein formulations/monoclonal antibodies.
• 9.Pregnant or lactating women.

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

Sponsors

Mabwell (Shanghai) Bioscience Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

Fudan University Cancer Hospital of China

Locations

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian Zhang, Professor

Role: CONTACT

syner2000@163.com

18017312991

Facility Contacts

Jian Zhang, Professor

Role: primary

syner2000@163.com

18017312991

Other Identifiers

6MW3211-2021-CP101

Identifier Type: -

Identifier Source: org_study_id