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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05048160
Other study ID # 6MW3211-2021-CP101
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 27, 2021
Est. completion date December 2024

Study information

Verified date May 2022
Source Mabwell (Shanghai) Bioscience Co., Ltd.
Contact Jian Zhang, Professor
Phone 18017312991
Email syner2000@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 272
Est. completion date December 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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).

Locations

Country Name City State
China Fudan University Cancer Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Mabwell (Shanghai) Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary AEs All the adverse events Up to 28 days post last dose
Primary ORR Objective Response Rate 1 Year
Primary DOR Duration of Remission 1 Year
Primary PFS Progression-Free Survival 1 Year
Primary DCR Disease Control Rate 1 Year
Primary OS Overall Survival 1 Year
Secondary PK Parameters The area under the curve (AUC) 1 Year
Secondary PK Parameters Maximum concentration(Cmax) 1 Year
Secondary PK Parameters Time at which maximum concentration(Tmax) 1 Year
Secondary PK Parameters The half life(T1/2) 1 Year
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