NCT05048160

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)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 272 (estimated)
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-09-27
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2021-09-17
• Last updated: 2022-05-09

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study