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Liver Cancer, AdultPhase 1MTS105 for HCCNCT06689540

Mts105 for Advanced Hepatocellular Carcinoma

A Phase 1 study testing MTS105 in people with Liver Cancer, Adult and Metastatic Liver Cancers, run by Shen Lin at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is the first-in-human trial of MTS105 (mRNA-LNP). The goal of this clinical trial is to evaluate the safety, tolerability of intravenous injection of MTS105 in advanced hepatocellular carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MTS105
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteChina
Study dates
18 Nov 2024to 31 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Histologically or cytologically confirmed diagnosis of hepatocellular carcinoma (HCC), excluding fibrolamellar or sarcomatoid subtypes, as well as mixed hepato-cholangiocellular carcinoma;
  • Positive for GPC3 expression per immunohistochemical (IHC) staining.
  • Failure of standard systemic therapies, including at least one immune checkpoint inhibitor and one targeted therapy (Tyrosine Kinase Inhibitors, and/or anti vascular endothelial growth factor agent).
  • Presence of a measurable tumor lesion (per RECIST/ mRECIST criteria).
  • Barcelona Clinical Liver Cancer Stage B or C (BCLC B/C)
  • Child-Pugh Score ≤ 6
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  • ECOG score ≤ 1
  • Adequate organ and bone marrow function as defined by the following laboratory criteria:
  • Hematology: No blood transfusion or colony-stimulating factor therapy within 7 days prior to the first dose. The following hematological parameters should be met:Absolute neutrophil count ≥ 1.5 × 10^9/L;Lymphocyte count ≥ 0.5 × 10^9/L;Hemoglobin ≥ 90 g/L;Platelet count ≥ 75 × 10^9/L;
  • Liver function:Total bilirubin ≤ 2.5 mg/dL;Albumin ≥ 28 g/L;Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × ULN;
  • International Normalized Ratio (INR) ≤ 2.3;Oral anticoagulant therapy at a stable dose for at least 2 weeks. If oral warfarin is used, the patient must have an INR ≤ 3.0 and no bleeding events within 28 days prior to administration;
  • Renal function:Serum creatinine ≤ 1.5 × ULN, or endogenous creatinine clearance ≥ 45 mL/min (as determined by the CKD-EPI formula);Urinary protein < 2+, or urinary protein ≥ 2+ but with 24-hour protein quantification ≤ 1.0 g
  • Cardiac function:Left ventricular ejection fraction (LVEF) ≥ 50%; No clinically significant abnormal ECG findings (chronic atrial fibrillation is allowed, provided it does not require medication);
  • Capable of full communication with the investigator, with the ability to understand and comply with study requirements, and able to understand and sign the informed consent form (ICF).
  • ≥18 years

Who cannot join

  • Any known active intracranial metastases, or brain metastases that have been treated for less than 4 weeks.
  • Recent Antitumor Therapy:
  • Treatment with any immune checkpoint inhibitor within 4 weeks (28 days) prior to the first dose.
  • Received any investigational drug within 4 weeks prior to the first dose.
  • Received localized therapy for hepatocellular carcinoma (HCC), including but not limited to arterial chemoembolization (TACE), arterial infusion chemotherapy (HAIC), Y-90 radioembolization, ablative therapy, or stereotactic radiation therapy (SBRT), within 4 weeks prior to the first dose.
  • Received other anticancer therapies, such as multi-targeted tyrosine kinase inhibitors (mTKIs) and/or anti-VEGF therapies, within 3 weeks.
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  • Received non-specific immunomodulatory therapy, including but not limited to interleukin, interferon, thymidine, etc., within 2 weeks prior to the first dose.
  • Received herbal or proprietary Chinese medicine for antitumor indications within 1 week prior to the first dose.
  • Previously received experimental treatment targeting GPC3 (patients may be enrolled if they remain positive for GPC3 upon testing).
  • History of liver transplantation or hematopoietic stem cell transplantation.
  • Unresolved toxicity from prior anticancer therapy (> grade 1, according to CTCAE v5.0).
  • Major surgery (other than biopsy) within 28 days prior to the first dose.
  • Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 90 mmHg).
  • Class III-IV heart failure by New York Heart Association (NYHA) criteria within 6 months prior to the first dose, unstable angina, myocardial infarction, bypass surgery, stent placement, cerebral infarction, or clinically significant valvular heart disease.
  • QTcF ≥ 450 ms in men and ≥ 470 ms in women (by Fridericia formula).
  • Severe infection within 4 weeks before the first dose (excluding viral hepatitis), or any signs or symptoms of active infection within 2 weeks before the first dose, or patients requiring antibiotic treatment within 2 weeks (excluding local medications and prophylactic antibiotics); unexplained fever > 38.5°C before the first dose.
  • For HBV-associated HCC:
  • HBsAg (+) : less than 2 weeks of HBV antiviral standard treatment before the first administration of study drug, with an HBV DNA viral load ≥ 1000 IU/mL.
  • HBcAb (+) , HBsAg (-): HBV DNA viral load ≥ 1000 IU/mL.
  • Hepatitis C virus-infected subjects who have not completed 4 weeks of antiviral treatment.
  • Positive for human immunodeficiency virus (HIV+).
  • Subjects requiring systemic corticosteroids (equivalent dose of prednisone > 10 mg/day) or other immunosuppressive drugs within 14 days prior to the first dose or during the study.
  • History of autoimmune disease requiring systemic treatment within 2 years prior to the first dose.
  • History of other malignancies within 2 years prior to the first dose (excluding cured skin basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ, breast ductal carcinoma in situ, or other cancers that the investigator believes are cured and have an extremely low risk of recurrence).
  • Women who are pregnant or breastfeeding.
  • Any other condition that, in the opinion of the investigator, makes participation in the study inappropriate.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lin Professor, M.D contact

010 88196561

Linshenpku@163.com

China1 site, 1 recruiting

  • Peking University Cancer Hospital

    Beijing

    Lin Shen, Ph.D, +86 1088196561, linshenpku@163.com

    Changsong Qi, M.D., xiwangpku@126.com

    Recruiting

Other trials in China

About this study

Official title: First-in-human Clinical Study of Mts105 for Advanced Hepatocellular Carcinoma

This is the first-in-human trial of MTS105 (mRNA-LNP). The goal of this clinical trial is to evaluate the safety, tolerability of intravenous injection of MTS105 in advanced hepatocellular carcinoma.

Read the detailed description

MTS105 is an mRNA-LNP combination. Once the mRNA is delivered to the liver via lipid nanoparticles (LNP), it translates into a therapeutic bispecific T-cell engager designed to activate T cells to target and destroy liver cancer cells.

MTS105 is anticipated to offer liver-targeted delivery, specific binding to hepatocellular carcinoma cells, a broad therapeutic window, and potent anti-tumor effects.

Being tested
MTS105
Keywords
hcc, mts105, metis, mRNA, LNP
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

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

  • MTS105Biological

    MTS105 is a combination of mRNA, which encodes a therapeutic protein, and its delivery vehicle, a lipid nanoparticle (LNP). The starting dose is estimated based on the Minimal Anticipated Biological Effect Level (MABEL) derived from non-clinical studies.

    A starting dose of 0.05 μg/kg was proposed for this study; following dose strength for escalation are: 0.5 μg/kg, 3.0 μg/kg, 15 μg/kg, 30 μg/kg, 45 μg/kg.

Study groups in NCT06689540
Study groupRoleWhat they receive
dose level #1ExperimentalStarting dose, 0.05 ug/kg
Receives: Biological: MTS105
dose level #2Experimentaldose escalation, 0.5 ug/kg
Receives: Biological: MTS105
dose level #3Experimentaldose escalation, 3.0 ug/kg
Receives: Biological: MTS105
dose level #4Experimentaldose escalation, 15.0 ug/kg
Receives: Biological: MTS105
dose level #5Experimentaldose escalation, 30.0 ug/kg
Receives: Biological: MTS105
dose level #6Experimentaldose escalation, 45.0 ug/kg
Receives: Biological: MTS105

What is being measured

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

  1. Incidence of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs).

    Incidence of TEAEs,and SAEs.

    Measured: From enrollment to the end of treatment at 4 weeks

  2. Maximal Tolerance Dose (MTD)

    Determined based on the occurrence of dose-limiting toxicity (DLT).

    Measured: Within the first 28-days following first dose

Secondary outcomes (9)

  1. Peak Plasma Concentration (Cmax)

    Peak Plasma Concentration of the investigational product

    Measured: Within the first 28-days following first dose

  2. Area under the plasma concentration versus time curve (AUC)

    Measured: Within the first 28-days following first dose

  3. Time for peak concentration (Tmax)

    Time for peak concentration

    Measured: Within the first 28-days following first dose

  4. Elimination half-life

    Elimination rate of the therapeutic protein in circulation.

    Measured: Within the first 28-days following first dose

  5. Steady-state concentration

    steady-state concentration

    Measured: Within the first 28-days following first dose

  6. Objective Response Rate

    The proportion of participants who have a confirmed CR or confirmed PR as determined by the investigator at local site per RECIST v1.1 or mRECIST 1.1

    Measured: through study completion, an average of 1 year

  7. Duration of Response (DOR)

    The time from first documented confirmed response until date of documented progression of disease, as determined by investigator at local site or death due to any cause.

    Measured: through study completion, an average of 1 year

  8. Progression Free Survival (PFS)

    Time from infusion date until progression, as assessed by the investigator at local site, or death due to any cause.

    Measured: through study completion, an average of 1 year

  9. Overall Survival (OS)

    Overall Survival (OS)

    Measured: through study completion, an average of 1 year

Timeline

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

  1. First posted14 Nov 2024
  2. Study start18 Nov 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (estimated)

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
Bayesian Optimal Interval (BOIN) Design
Masking
None (open label)
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06689540
Sponsor's protocol ID
MTS105-01
Acronym
MTS105 for HCC
Status last verified
Oct 2024
First submitted
8 Nov 2024
Last updated
24 Dec 2024
Results posted
No
Data monitoring committee
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 MTS105 in people with Liver Cancer, Adult and Metastatic Liver Cancers, run by Shen Lin 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 15 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 24 Dec 2024. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Lin Professor, M.D (010 88196561, Linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs). (time frame: From enrollment to the end of treatment at 4 weeks). 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 NCT06689540.

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 24 Dec 2024.

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