A Study of MSB2311 in Advanced Solid Tumors

NCT04272944 | Completed Phase 1 FDA Drug

• 1 other identifier: MSB2311-CSP-002
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of MSB2311

  Measured by number adverse events that are related to treatment

  Up to 90 days following the last dose

• 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

Secondary Outcomes (9)

• Area under the plasma concentration versus time curve (AUC) for MSB2311

  Up to 30 days following the last dose

• Peak Plasma concentration (Cmax)for MSB2311

  Up to 30 days following the last dose

• Time to the Maximum Observed Plasma Concentration (Tmax)

  Up to 30 days following the last dose

• Terminal elimination half-life (t1/2)

  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

Study Arms (2)

10 mg/kg Q2W

EXPERIMENTAL

10 mg/kg IV every 2 weeks

Drug: 10 mg/kg Q2W

20 mg/kg Q3W

EXPERIMENTAL

20 mg/kg IV every 3weeks

Drug: 20 mg/kg Q3W

Interventions

10 mg/kg Q2W DRUG

10 mg/kg MSB2311 every two weeks

Also known as: MSB2311 10 Q2W

10 mg/kg Q2W

20 mg/kg Q3W DRUG

20 mg/kg MSB2311 every three weeks.

Also known as: MSB2311 20 Q3W

20 mg/kg Q3W

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suzhou Transcenta Therapeutics Co., Ltd.: lead

Study Sites (1)

Mabspace Biosciences (Suzhou) Co., Ltd.

Suzhou, Jiangsu, 215123, China

Location

Study Officials

• Mengde Wang

  Suzhou Transcenta Therapeutics Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: MSB2311 IV at 10 mg/kg Q2W, 20 mg/kg 3QW

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: August 13, 2018
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: December 18, 2023

Record last verified: 2023-04

Locations

CN (1)