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Advanced Solid TumorPhase 1NCT04381325

A Study of MSB0254 Injection in Advanced Solid Tumors

A Phase 1 study testing MSB0254 Injection in people with Advanced Solid Tumor, run by Transcenta Therapeutics (Hangzhou) Co., Ltd. at 2 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study was an open, multi-dose dose escalation phase I clinical study to evaluate the safety, tolerability and PK characteristics of MSB0254 in patients with locally advanced or metastatic solid tumors, and to preliminarily measure its anti-tumor efficacy. 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?
MSB0254 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesChina
Study dates
1 Apr 2020to 8 Jun 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 by standard treatment failure or lack of standard treatment or inability to tolerate standard treatment;
  • For patients enrolled in the extended period:
  • Group 1: vascular rich tumors, including but not limited to neuroendocrine tumors, thymic squamous cell carcinoma and soft tissue Sarcoma, the specific categories are as follows. If it is necessary to enroll other types of tumor subjects, it is necessary to cooperate with the sponsor The responsible person shall discuss and confirm.
  • Neuroendocrine tumor (net): low and medium grade (G1 or G2) confirmed by histopathology: low grade Other (G1) was defined as mitotic image number < 2 / 10, high power field of view [HPF] and / or Ki-67 differentiation Index < 3%; The intermediate level (G2) is defined as the number of mitotic images 2-20 / 10 high-power field of vision[HPF] and / or Ki-67 differentiation index 3-20%. If the mitotic image and Ki of the same tumor tissue-67 indicators correspond to different levels and follow higher levels;
  • Thymic squamous cell carcinoma (TSCC): thymic squamous cell carcinoma confirmed by histology or cytology;
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  • Soft tissue sarcoma (STS): soft tissue sarcoma confirmed by histology or cytology;
  • Group 2: hepatocellular carcinoma (HCC): hepatocellular carcinoma confirmed histologically or cytologically. Barcelona Clinic Liver cancer stage B and C (BCLC B and C)
  • The eastern United States cooperative tumor group (ECOG) score was 0 or 1
  • Expect to survive at least 3 months
  • Must have at least one assessable lesion as defined in RECIST v1.1;
  • Suitable organs and hematopoietic function should be available. Laboratory tests during screening should meet the appropriate criteria:
  • Male and female subjects of childbearing age will agree to use effective, investigator-approved contraceptive methods from the date of the informed consent until 3 months after the last administration
  • Previous treatment of subjects enrolled in the extended study:
  • Net: Net subjects with disease progression after at least 2-wire system antitumor drug treatment regimen: connected Systematic treatment for unresectable net, followed by recurrence / progression, or intolerance, or Unwilling to receive treatment. Frontline treatment may include somatostatin analogues, interferon, PRRT (peptide) Receptor radionuclide therapy), mTOR inhibitor or chemotherapy (unlimited chemotherapy drugs and times, Chemotherapy is regarded as a drug treatment regimen), anti angiogenesis drugs (including anti VEGF-A monoclonal antibody) Or VEGFR tyrosine kinase inhibitor);
  • Thymic squamous cell carcinoma and soft tissue sarcoma: failure of previous conventional systemic chemotherapy;
  • HCC: HCC subjects with disease progression or intolerance after treatment with 2-line system antitumor drugs: after receiving systematic treatment for unresectable HCC, they relapse / progress, or are unable to tolerate Those who are affected or unwilling to receive treatment. Frontline systemic therapy must include immune checkpoint inhibitors and anti-inflammatory drugs Angiogenesis drugs (including anti-vegf-a monoclonal antibody or VEGFR tyrosine kinase inhibitor).

Who cannot join

  • Had suffered from malignant tumors other than the primary tumor at the time of enrollment within 5 years before screening (except: after Fully treated cervical carcinoma in situ, local squamous cell carcinoma of the skin, basal cell carcinoma, localized cancer Adenocarcinoma, ductal carcinoma in situ or stage I uterine cancer);
  • High grade (G3) neuroendocrine carcinoma, adenoid carcinoma, islet cell carcinoma, goblet cell carcinoid, large Cellular neuroendocrine carcinoma and small cell carcinoma;
  • Functional net and need to be accompanied by the use of long-acting somatostatin analogues to control symptoms, such as insulinoma Gastrinoma, glucagon tumor, somatostatin tumor, adrenocorticotropic hormone tumor, vascular activity Intestinal peptidoma with carcinoid syndrome, zoai syndrome or disease-specific active symptoms-
  • Patients with symptoms of brain or pia meningeal metastases.
  • The lung metastasis of the tumor has a cavity, or the investigator judges that there is bleeding tendency or bleeding risk;
  • patients requiring local treatment or repeated drainage, the investigator identified poorly controlled effusion of the body cavity (pleural fluid, ascites, pericardial effusion, etc.)
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  • The adverse reactions of previous treatment did not recover to CTCAEv5.0 score ≤1 (excluding hair loss and anemia);
  • Had received any previous systemic therapy targeting VEGF or VEGFR2 signaling pathway;
  • Drugs or chemotherapy or radiotherapy received in other clinical trials within 4 weeks prior to enrollment (mitomycin C and nitrosorea should be administered at least 6 weeks before the last dose)
  • Patients who had major surgery within 4 weeks prior to screening (excluding needle biopsy) and who were expected to have major surgery during the study period (including the 28-day screening period) or had severe unhealed wounds, ulcers, or trauma
  • Left ventricular ejection fraction ≤50%;
  • Heart failure patients with greater than or equal to Ⅱ level（NYHA）;
  • Clinically significant arrhythmias (including frequent ventricular premature beats, symptomatic or treatable ventricular tachycardia, and asymptomatic persistent ventricular tachycardia);
  • After regular antihypertensive treatment for 4 weeks, the blood pressure did not reach systolic blood pressure < 150mmhg and / or diastolic blood pressure < 150mmhg 90mmHg, or after regular antihypertensive treatment, the blood pressure reaches systolic blood pressure < 150mmhg and / or diastolic blood pressure The duration of pressure < 90mmHg is less than 4 weeks
  • There are currently venous thromboemboli that require treatment;
  • Myocardial infarction, stroke or other severe arterial thromboembolism events occurred within 6 months before enrollment.
  • Any grade 2 or more bleeding occurred within 6 months prior to enrollment;
  • Intraperitoneal abscess, or abdominal wall fistula, gastrointestinal perforation, or a history of poorly controlled/recurrent inflammatory bowel disease (including crohn's disease or ulcerative colitis) occurred within 6 months prior to enrollment.
  • The patient is receiving （NSAIDS;Such as indomethacin, ibuprofen, naproxen or similar drugs) or antiplatelet drugs (such as clopidogrel, ticlopidine, dipyridamole or analgrel) for long-term treatment;Aspirin is permitted with a maximum dose of 325 mg per day;Celecoxib is permitted for analgesic treatment;However, low-dose aspirin (≤325mg/d) and celecoxib should not be used at the same time.
  • Patients are known to be allergic to MSB0254 or its excients, monoclonal antibodies, or any other therapeutic protein, such as fresh frozen plasma, human serum albumin (HSA), cytokines, or interleukin.If severe allergic reactions are suspected (CTCAE v5.0 grade ≥3), the patient should be excluded.
  • Urine protein concentration of patients according to dipstick or routine urine analysis (UA) is >1 +,The patients also had edema or serum albumin levels below the lower limit of the normal range (LLN).Alternatively, if the urine protein concentration of the patient is ≥2+ according to the dipstick or routine urine analysis, the urine protein concentration in the 24-hour urine protein analysis must be>1g, accompanied by edema or serum albumin lower than LLN;
  • Patients with a known history of hepatitis c or chronic active hepatitis b. Except for HBV carriers, hepatitis b patients who are stable after drug treatment (hbv-dna titer must not be higher than 1000 copies [CPS]/mL or 200 IU/mL) and hepatitis c patients who are stable after drug treatment (hcv-rna negative)
  • A known history of HIV infection or a positive test for human immunodeficiency virus (HIV);
  • Positive treponema pallidum test;
  • A history of alcohol, drug or substance abuse in the past 1 year;
  • Has a clear history of neurological or mental disorders, such as epilepsy or dementia;
  • Poor compliance of the subject;
  • Women who are pregnant (confirmed by a urine or serum pregnancy test) or breast-feeding;
  • the investigators concluded that the study was not suitable for participants for other reasons

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310003

  • FuDan University ZhongShan Hospital

    Shanghai

Other trials in China

About this study

Official title: Phase I Clinical Trial to Evaluate the Safety and Tolerability and Pharmacokinetics of MSB0254 Injection in Patients With Advanced Solid Tumors

This study was an open, multi-dose dose escalation phase I clinical study to evaluate the safety, tolerability and PK characteristics of MSB0254 in patients with locally advanced or metastatic solid tumors, and to preliminarily measure its anti-tumor efficacy.

Being tested
MSB0254 Injection

What participants receive

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

  • MSB0254 InjectionDrug

    An intravenous infusion with concentration from 4 mg/kg to 16 mg/kg every 2 weeks (Q2W).

    An intravenous infusion with concentration 20 mg/kg every 3 weeks (Q3W).

Study groups in NCT04381325
Study groupRoleWhat they receive
MSB0254 InjectionExperimentalThis experiment will start from 4mg/kg with a dose increase of 3+3, and is planned to be carried out in 5 dose groups, namely 4mg/kg, 8mg/kg (100% increase), 12mg/kg (50% increase), 16mg/kg (33% increase) and 20mg/kg (25% increase).MSB0254 injection was administered intravenously on day 1 and day 15 every 28 days.To collect pharmacokinetic blood samples after repeated administration, MSB0254 injection was not administered on day 1 of the third cycle (C3D1).The observation period of DLT was 28 days after the first administration. An intravenous infusion with concentration 20 mg/kg every 3 weeks (Q3W).
Receives: Drug: MSB0254 Injection

What is being measured

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

  1. Safety and tolerability of MSB0254

    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 (8)

  1. Area under the plasma concentration versus time curve (AUC) for MSB0254

    Changes in AUC over time in subjects with MSB0254

    Measured: Up to 30 days following the last dose

  2. Peak Plasma concentration (Cmax)for MSB0254

    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. The immunogenicity of MSB0254 injection

    The immunogenicity of MSB0254 injection was evaluated by testing the production of anti-drug antibody (ADA).

    Measured: Up to 30 days following the last dose

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

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

    Measured: Up to 90 days following the last dose

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

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

    Measured: Up to 90 days following the last dose

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

    Progression-free survival (PFS) 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 posted8 May 2020
  2. Study start1 Apr 2020
  3. Primary completion8 Jun 2022
  4. Study completion8 Jun 2022

Why it stopped: Sponsor Decision

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04381325
Sponsor's protocol ID
MSB0254-CSP-001
Status last verified
Mar 2023
First submitted
7 May 2020
Last updated
5 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MSB0254 Injection in people with Advanced Solid Tumor, run by Transcenta Therapeutics (Hangzhou) Co., Ltd. at 2 sites 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 17 inclusion and 29 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: stopped early, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 was stopped early (reason given: Sponsor Decision). Results are not available in the source record.

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 MSB0254 (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 NCT04381325.

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 5 Apr 2023.

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