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Advanced Solid TumorPhase 1NCT04272944

A Study of MSB2311 in Advanced Solid Tumors

A Phase 1 study testing 10 mg/kg Q2W and 20 mg/kg Q3W in people with Advanced Solid Tumor, run by Transcenta Therapeutics (Hangzhou) Co., Ltd. at 1 site in China.

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 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
10 mg/kg Q2W and 20 mg/kg Q3W
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteChina
Study dates
13 Aug 2018to 31 Jan 2022
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Mabspace Biosciences (Suzhou) Co., Ltd.

    Suzhou, Jiangsu, 215123

Other trials in China

About this study

Official title: 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.

Being tested
10 mg/kg Q2W, 20 mg/kg Q3W

What participants receive

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

  • 10 mg/kg Q2WDrug

    Also called MSB2311 10 Q2W

    10 mg/kg MSB2311 every two weeks

  • 20 mg/kg Q3WDrug

    Also called MSB2311 20 Q3W

    20 mg/kg MSB2311 every three weeks.

Study groups in NCT04272944
Study groupRoleWhat they receive
10 mg/kg Q2WExperimental10 mg/kg IV every 2 weeks
Receives: Drug: 10 mg/kg Q2W
20 mg/kg Q3WExperimental20 mg/kg IV every 3weeks
Receives: Drug: 20 mg/kg Q3W

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(MTD) or recommended phase2 dose（RP2D）

    Measured by number of subjects experiencing DLT in each escalation cohort

    Measured: Up to 90 days following the last dose

Secondary outcomes (9)

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

    Changes in AUC over time in subjects with MSB2311

    Measured: Up to 30 days following the last dose

  2. Peak Plasma concentration (Cmax)for MSB2311

    Cmax is the maximum observed plasma concentration

    Measured: Up to 30 days following the last dose

  3. Time to the Maximum Observed Plasma Concentration (Tmax)

    Tmax is the time in hours/days to reach Cmax following dosing

    Measured: Up to 30 days following the last dose

  4. 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

    Measured: Up to 30 days following the last dose

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

    Measured: Up to 90 days following the last dose

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

    Measured: Up to 90 days following the last dose

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

    Measured: Up to 90 days following the last dose

  8. Best overall response as measured by RESISTv1.1

    Measured: Up to 90 days following the last dose

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

    Measured: Up to 90 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 posted17 Feb 2020
  2. Study start13 Aug 2018
  3. Primary completion31 Jan 2022
  4. Study completion31 Jan 2022

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
MSB2311 IV at 10 mg/kg Q2W, 20 mg/kg 3QW
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04272944
Sponsor's protocol ID
MSB2311-CSP-002
Status last verified
Apr 2023
First submitted
12 Feb 2020
Last updated
18 Dec 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 10 mg/kg Q2W and 20 mg/kg Q3W in people with Advanced Solid Tumor, run by Transcenta Therapeutics (Hangzhou) Co., Ltd. at 1 site in China.

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 9 inclusion and 18 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 China. 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 NCT04272944.

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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