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

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)

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 .

Study Overview

• Status: Recruiting
• Conditions: Advanced Malignant Neoplasm
• Intervention / Treatment: Drug: Intravenous Infusion

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.

• Study Type: Interventional
• Enrollment (Anticipated): 272
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 6MW3211; Dosage form: injection; Specification: 240 mg / 8 ml/Vial	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs	All the adverse events	Up to 28 days post last dose
ORR	Objective Response Rate	1 Year
DOR	Duration of Remission	1 Year
PFS	Progression-Free Survival	1 Year
DCR	Disease Control Rate	1 Year
OS	Overall Survival	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK Parameters	The area under the curve (AUC)	1 Year
PK Parameters	Maximum concentration(Cmax)	1 Year
PK Parameters	Time at which maximum concentration(Tmax)	1 Year
PK Parameters	The half life(T1/2)	1 Year

Collaborators and Investigators

• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
• Investigators: Principal Investigator: Jian Zhang, Professor, Fudan University Cancer Hospital of China

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 27, 2021
• Primary Completion (ANTICIPATED): June 1, 2024
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (ACTUAL): September 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 6MW3211-2021-CP101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No