A Phase I Study of MSB2311 in Advanced Solid Tumors

December 11, 2023 updated by: Suzhou Transcenta Therapeutics Co., Ltd.

First-in-human, Open-label, Phase 1 Dose-Escalation Study of MSB2311, A Humanized Anti-PD-L1 Monoclonal Antibody in Subjects With Advanced Solid Tumors

This is a phase I study to determine the safety and toxicity, PK/PD, immunogenicity, biomarkers, anti-tumor activity and establish a preliminary recommended Phase 2 dose (RP2D) in subjects with advanced solid tumors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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, biomarkers, and anti-tumor activity of MSB2311.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Able to understand and willing to sign the ICF.
  • Male or female subject ≥ 18 years.
  • Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors that are refractory to standard therapy, or for which no standard therapy exists.
  • Subject has measurable disease per RECIST v1.1.
  • ECOG Performance Status 0 to 1
  • Subjects with life expectancy of ≥ 3 month
  • No herbal/alternative medications prior to the first dose
  • Must have adequate hematological, hepatic and renal function as defined in the protocol.
  • Prior anti-tumor therapies of different kinds must have stopped before the first dose as defined by protocol
  • Effective contraception for both male and female subjects if the risk of conception exists

Exclusion Criteria:

  • Pregnant or nursing females.
  • Any remaining AEs > grade 1 from prior anti-tumor treatment as per CTCAE v4. 03, with exception of the residual hair loss;
  • Received a biologic G-CSF, GM-CSF or erythropoietin within 14 days prior to the first dose of study drug;
  • Subjects who had prior treatment with an anti-PD-L1 product
  • History of documented autoimmune disease except for autoimmune hypothyroidism and well-controlled Type 1 diabetes mellitus.
  • W/o autoimmune condition requiring systemic treatment with immunosuppressive medications within 14 days before the planned first dose of study drug.
  • Primacy central nervous system (CNS) malignancy or symptomatic CNS metastases are not allowed, with exceptions defined in protocol.
  • Major surgery within the 28-days from the screening
  • Subjects with idiopathic pulmonary fibrosis or unresolved active or chronic inflammatory pulmonary disease are excluded.
  • History of human immunodeficiency virus (HIV) infection, active hepatitis B or C. HBV carriers
  • History of primary immunodeficiency, stem cell or organ transplant, or previous clinical diagnosis of tuberculosis disease.
  • Clinically significant acute infections 4 weeks and any infection 2 weeks prior to the first dose administration.
  • Known allergies, hypersensitivity, or intolerance to protein-based therapies or with a history of any significant drug allergy
  • Subjects who experienced immunotherapy-related adverse events (irAE) grade ≥ 3, or who had to discontinue prior anti-PD-1 treatment due to irAEs of any grade.
  • Severe or uncontrolled cardiac disease requiring treatment as defined in protocol
  • Any other serious underlying medical, psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, might impair the subject's benefit from the trial treatment
  • Known history of hypersensitivity to any components of the MSB2311 product.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 3 mg/kg (Q3W) MSB2311 Injection
MSB2311 will be administered as an IV infusion once every 3 weeks (Q3W) starting at 3 mg/kg.
Drug: 3 mg/kg Q3W MSB2311 Injection
An intravenous infusion with concentration from 3 mg/kg (Q3W)
Other Names:
  • 3 mg/kg Q3W MSB2311
Experimental: 10 mg/kg (Q3W) MSB2311 Injection
MSB2311 will be administered as an IV infusion once every 3 weeks (Q3W) starting at 10 mg/kg.
Drug: 10 mg/kg Q3W MSB2311 Injection
An intravenous infusion with concentration from 10 mg/kg (Q3W)
Other Names:
  • 10 mg/kg Q3W MSB2311
Experimental: 20 mg/kg (Q3W) MSB2311 Injection
MSB2311 will be administered as an IV infusion once every 3 weeks (Q3W) starting at 20 mg/kg.
Drug: 20 mg/kg Q3W MSB2311 Injection
An intravenous infusion with concentration from 20 mg/kg (Q3W)
Other Names:
  • 20 mg/kg Q3W MSB2311
Experimental: 10 mg/kg (Q2W) MSB2311 Injection
MSB2311 will be administered as an IV infusion once every 2weeks (Q2W) starting at 10 mg/kg.
Drug: 10 mg/kg Q2W MSB2311 Injection
An intravenous infusion with concentration from 10 mg/kg (Q2W)
Other Names:
  • 10 mg/kg Q2W MSB2311

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and tolerability of MSB2311
Time Frame: Up to 90 days following the last dose
Measured by number adverse events that are related to treatment
Up to 90 days following the last dose
Maximum tolerated dose or recommended phase 2 dose
Time Frame: Up to 90 days following the last dose
Measured by number of subjects experiencing DLT in each escalation cohort
Up to 90 days following the last dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration versus time curve (AUC) for MSB2311
Time Frame: Up to 30 days following the last dose
Up to 30 days following the last dose
Peak Plasma concentration (Cmax)for MSB2311
Time Frame: Up to 30 days following the last dose
Incidence and quantity of anti-drug antibodies
Up to 30 days following the last dose
Volume of plasma from which MSB2311 is completely removed per unit time (CL)
Time Frame: Up to 30 days following the last dose
Up to 30 days following the last dose
The incidence of subjects generating anti-drug antibody
Time Frame: Up to 30 days following the last dose
Up to 30 days following the last dose
Objective response rate (ORR) as measured by RESISTv1.1
Time Frame: Up to 30 days following the last dose
Up to 30 days following the last dose
Duration of response (DOR) as measured by RESISTv1.1
Time Frame: Up to 30 days following the last dose
Up to 30 days following the last dose
Progression-free survival (PFS) as measured by RESISTv1.1
Time Frame: Up to 30 days following the last dose
Up to 30 days following the last dose
Best overall response as measured by RESISTv1.1
Time Frame: Up to 30 days following the last dose
Up to 30 days following the last dose
Overall survival (OS) as measured by RESISTv1.1
Time Frame: Up to 30 days following the last dose
Up to 30 days following the last dose
Elimination half-life and apparent plasma terminal phase elimination rate constant (t1/2 ) of MSB2311
Time Frame: Up to 30 days following the last dose
Up to 30 days following the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suzhou Transcenta Therapeutics Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yonggang Wu, MD, Suzhou Transcenta Therapeutics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MSB2311-CSP-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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