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

Advanced Malignant Neoplasm Clinical Trial

Official title:

Phase I/II Clinical Trial of 6MW3211 Injection to Evaluate Safety, Tolerability, PK/PD, Immunogenicity and Preliminary Efficacy in Subjects With Advanced Malignant Neoplasm.(Only Phase I Has Been Submitted to US FDA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05048160
• Other study ID #: 6MW3211-2021-CP101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Advanced Malignant Neoplasm
• Neoplasms

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