Clinical trial NCT05048160: A Clinical Study of 6MW3211 Injection in the Treatment of Advanced Malignant Neoplasm
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Advanced Malignant Neoplasm
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-17
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .

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.

Eligibility criteria: 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.

Primary outcomes:
measure: AEs
timeFrame: Up to 28 days post last dose
measure: ORR
timeFrame: 1 Year
measure: DOR
timeFrame: 1 Year
measure: PFS
timeFrame: 1 Year
measure: DCR
timeFrame: 1 Year
measure: OS
timeFrame: 1 Year
Secondary outcomes:
measure: PK Parameters
timeFrame: 1 Year
measure: PK Parameters
timeFrame: 1 Year
measure: PK Parameters
timeFrame: 1 Year
measure: PK Parameters
timeFrame: 1 Year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University Cancer Hospital of China
name: Jian Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References: