A Study of MSB2311 in Advanced Solid Tumors

Phase I Clinical Trial on the Tolerability and Pharmacokinetics of Recombinant Humanized Anti-PD-L1 Monoclonal Antibody MSB2311 Injection in the Treatment of Patients With Advanced Solid Tumors

This is a first-in-human (FIH), open-label, Phase 1 dose-Escalation Study of MSB2311, a humanized anti-PD-L1 monoclonal antibody, in subjects with advanced solid tumors. Qualified subjects will be enrolled to receive their assigned dose regimen of MSB2311 until disease progression or intolerable toxicity, withdrawal of consent, or end of study, whichever occurs first. The maximum treatment duration is 2 years. During the study, subjects will be evaluated for safety and toxicity, PK/PD, immunogenicity and anti-tumor activity of MSB2311.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: 10 mg/kg Q2W; Drug: 20 mg/kg Q3W

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215123
      • Mabspace Biosciences (Suzhou) Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Voluntary informed consent, knowledge of the study and willingness to follow and has ability to complete all trial procedures

• There is a histologically or cytologically confirmed, locally advanced or metastatic tumor that is not resectable

  • b period participants shall provide the archive paraffin embedding tumor tissue samples
• The eastern United States cooperative tumor group (ECOG) score was 0 or 1
• Expect to survive at least 3 months
• Subjects must have measurable lesions (at least 1 lesion) and minimum tumor-specific antigen levels where applicable
• If you have received antitumor therapy, you need to meet certain conditions
• There are suitable organs and hematopoietic functions
• Male subjects and female subjects of child-bearing age shall agree to take effective, investigator-approved contraceptive measures from the date of signing the informed consent until 3 months after the last administration

Exclusion Criteria:

• The patient has had a malignant tumor other than the tumor treated in this study within 5 years prior to the first administration, unless the medical examiner of the study group and sponsor agrees that the old tumor has been cured or will not metastasise or cause death in this study
• Adverse reactions to previous treatments did not return to CTCAE v4.03 rating ≤ 1, except for residual alopecia effect
• Patients who had been treated with anti-pd-1 or pd-l1 antibodies, or who had been treated with antibodies/drugs that target any other t-cell co-regulatory proteins within 12 weeks of the first administration of the drug in this study
• Patients with primary CNS tumors or CNS metastases known or identified during screening
• Subjects with active or pre-existing autoimmune disease that may recur or patients at high risk
• Patients who had major surgery in the first 4 weeks of screening and who were expected to have major surgery during the study period including a 28-day screening period
• Subjects who require systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment or during the study period
• Sudden pulmonary disease, interstitial pulmonary disease or pneumonia, or other uncontrolled systemic disease, including diabetes, pulmonary fibrosis, acute pulmonary disease, cardiovascular disease, including hypertension, except local interstitial pneumonia induced by radiotherapy
• A history of human immunodeficiency virus infection, or other acquired or congenital immunodeficiency, or a history of organ transplantation, or stem cell transplantation
• Had a history of tuberculosis, or had tuberculosis disease at the time of screening
• Patients with chronic hepatitis b or active hepatitis c.Hepatitis b carriers, stable hepatitis b after drug treatment and cured hepatitis c patients can be included in the group
• Patients who have been seriously infected within 4 weeks prior to first administration, or who have developed signs or symptoms of any active infection within the previous 2 weeks, or who require antibiotic treatment within the previous 2 weeks;Unexplained fever occurred before the first administration and the body temperature exceeded 38.5℃
• Subjects who have previously been known to have a severe allergic reaction to a macromolecular protein preparation/monoclonal antibody or to any component of the test drug
• Immune-related adverse events (irAE) grade ≥3 occurred after receiving immunotherapy
• Participated in clinical trials of other drugs within 4 weeks before enrollment
• A history of alcohol, drug or substance abuse within the last 1 year
• Has a clear history of neurological or psychiatric disorders, such as epilepsy, dementia, poor compliance
• A woman who is pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 mg/kg Q2W; 10 mg/kg IV every 2 weeks	Drug: 10 mg/kg Q2W; 10 mg/kg MSB2311 every two weeks; Other Names: MSB2311 10 Q2W
Experimental: 20 mg/kg Q3W; 20 mg/kg IV every 3weeks	Drug: 20 mg/kg Q3W; 20 mg/kg MSB2311 every three weeks.; Other Names: MSB2311 20 Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum tolerated dose(MTD) or recommended phase2 dose（RP2D）	Measured by number of subjects experiencing DLT in each escalation cohort	Up to 90 days following the last dose
Safety and tolerability of MSB2311	Measured by number adverse events that are related to treatment	Up to 90 days following the last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the Maximum Observed Plasma Concentration (Tmax)	Tmax is the time in hours/days to reach Cmax following dosing	Up to 30 days following the last dose
Terminal elimination half-life (t1/2)	The time required for the plasma level of the study drug to decrease by one-half during the terminal elimination phase	Up to 30 days following the last dose
Area under the plasma concentration versus time curve (AUC) for MSB2311	Changes in AUC over time in subjects with MSB2311	Up to 30 days following the last dose
Peak Plasma concentration (Cmax)for MSB2311	Cmax is the maximum observed plasma concentration	Up to 30 days following the last dose
Objective response rate (ORR) as measured by RESISTv1.1		Up to 90 days following the last dose
Duration of response (DOR) as measured by RESISTv1.1		Up to 90 days following the last dose
Progression-free survival (PFS) as measured by RESISTv1.1		Up to 90 days following the last dose
Best overall response as measured by RESISTv1.1		Up to 90 days following the last dose
Overall survival (OS) as measured by RESISTv1.1		Up to 90 days following the last dose

Collaborators and Investigators

• Sponsor: Suzhou Transcenta Therapeutics Co., Ltd.
• Investigators: Study Director: Mengde Wang, Suzhou Transcenta Therapeutics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2018
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: MSB2311-CSP-002

Drug and device information, study documents

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