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

NCT05048160 | Unknown Phase 1 FDA Drug

• 1 other identifier: 6MW3211-2021-CP101
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

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 .

Conditions

Advanced Malignant Neoplasm

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• PK Parameters

  1 Year

• PK Parameters

  1 Year

• PK Parameters

  1 Year

• PK Parameters

  1 Year

Study Arms (1)

6MW3211

EXPERIMENTAL

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

Drug: Intravenous Infusion

Interventions

Intravenous Infusion 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).

6MW3211

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

Infusions, Intravenous

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Officials

• Jian Zhang, Professor

  Fudan University Cancer Hospital of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Zhang, Professor

CONTACT

18017312991; syner2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 17, 2021
• Study Start: September 27, 2021
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)