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Advanced Solid TumorsPhase 1NCT03463473

A Phase I Study of MSB2311 in Advanced Solid Tumors

A Phase 1 study testing 3 mg/kg Q3W MSB2311 Injection, 10 mg/kg Q3W MSB2311 Injection and 20 mg/kg Q3W MSB2311 Injection in people with Advanced Solid Tumors, run by Transcenta Therapeutics (Hangzhou) Co., Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
3 mg/kg Q3W MSB2311 Injection, 10 mg/kg Q3W MSB2311 Injection and 20 mg/kg Q3W MSB2311 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
12 Apr 2018to 1 Jun 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
3 mg/kg Q3W MSB2311 Injection, 10 mg/kg Q3W MSB2311 Injection, 20 mg/kg Q3W MSB2311 Injection, 10 mg/kg Q2W MSB2311 Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3 mg/kg Q3W MSB2311 InjectionDrug

    Also called 3 mg/kg Q3W MSB2311

    An intravenous infusion with concentration from 3 mg/kg (Q3W)

  • 10 mg/kg Q3W MSB2311 InjectionDrug

    Also called 10 mg/kg Q3W MSB2311

    An intravenous infusion with concentration from 10 mg/kg (Q3W)

  • 20 mg/kg Q3W MSB2311 InjectionDrug

    Also called 20 mg/kg Q3W MSB2311

    An intravenous infusion with concentration from 20 mg/kg (Q3W)

  • 10 mg/kg Q2W MSB2311 InjectionDrug

    Also called 10 mg/kg Q2W MSB2311

    An intravenous infusion with concentration from 10 mg/kg (Q2W)

Study groups in NCT03463473
Study groupRoleWhat they receive
3 mg/kg (Q3W) MSB2311 InjectionExperimentalMSB2311 will be administered as an IV infusion once every 3 weeks (Q3W) starting at 3 mg/kg.
Receives: Drug: 3 mg/kg Q3W MSB2311 Injection
10 mg/kg (Q3W) MSB2311 InjectionExperimentalMSB2311 will be administered as an IV infusion once every 3 weeks (Q3W) starting at 10 mg/kg.
Receives: Drug: 10 mg/kg Q3W MSB2311 Injection
20 mg/kg (Q3W) MSB2311 InjectionExperimentalMSB2311 will be administered as an IV infusion once every 3 weeks (Q3W) starting at 20 mg/kg.
Receives: Drug: 20 mg/kg Q3W MSB2311 Injection
10 mg/kg (Q2W) MSB2311 InjectionExperimentalMSB2311 will be administered as an IV infusion once every 2weeks (Q2W) starting at 10 mg/kg.
Receives: Drug: 10 mg/kg Q2W MSB2311 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability of MSB2311

    Measured by number adverse events that are related to treatment

    Measured: Up to 90 days following the last dose

  2. Maximum tolerated dose or recommended phase 2 dose

    Measured by number of subjects experiencing DLT in each escalation cohort

    Measured: Up to 90 days following the last dose

Secondary outcomes (10)

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

    Measured: Up to 30 days following the last dose

  2. Peak Plasma concentration (Cmax)for MSB2311

    Incidence and quantity of anti-drug antibodies

    Measured: Up to 30 days following the last dose

  3. Volume of plasma from which MSB2311 is completely removed per unit time (CL)

    Measured: Up to 30 days following the last dose

  4. The incidence of subjects generating anti-drug antibody

    Measured: Up to 30 days following the last dose

  5. Objective response rate (ORR) as measured by RESISTv1.1

    Measured: Up to 30 days following the last dose

  6. Duration of response (DOR) as measured by RESISTv1.1

    Measured: Up to 30 days following the last dose

  7. Progression-free survival (PFS) as measured by RESISTv1.1

    Measured: Up to 30 days following the last dose

  8. Best overall response as measured by RESISTv1.1

    Measured: Up to 30 days following the last dose

  9. Overall survival (OS) as measured by RESISTv1.1

    Measured: Up to 30 days following the last dose

  10. Elimination half-life and apparent plasma terminal phase elimination rate constant (t1/2 ) of MSB2311

    Measured: Up to 30 days following the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2018
  2. Study start12 Apr 2018
  3. Primary completion1 Jun 2020
  4. Study completion1 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Dose escalation : 3mg/kg Q3W, 10 mg/kg Q3W, 20 mg/kg Q3W, 10 mg/kg Q2W
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03463473
Sponsor's protocol ID
MSB2311-CSP-001
Status last verified
May 2019
First submitted
28 Feb 2018
Last updated
18 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 3 mg/kg Q3W MSB2311 Injection, 10 mg/kg Q3W MSB2311 Injection and 20 mg/kg Q3W MSB2311 Injection in people with Advanced Solid Tumors, run by Transcenta Therapeutics (Hangzhou) Co., Ltd. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of MSB2311 (time frame: Up to 90 days following the last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03463473.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.

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