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Safety IssuesPhase 2MB07133NCT06141096

MB07133 for the Treatment of Patients With Unresectable Hepatocellular Carcinoma

A Phase 2 study testing MB07133 in people with Safety Issues and Effect of Drug, run by Xi'an Xintong Pharmaceutical Research Co.,Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A randomized, open, multicenter clinical trial design was adopted, planned to be conducted in three stages, with 91 participants expected to be included in the study to evaluate the efficacy, tolerance, and safety of different doses of MB07133 in the treatment of unresectable advanced primary liver cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Safety Issues, Effect of Drug, Tolerance
What is being tested?
MB07133
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteChina
Study dates
17 Jan 2020to 31 Dec 2025
Phase
Phase 2
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

  • Age range from 18 to 75 years old (including 18 and 75 years old), regardless of gender;
  • Patients with advanced unresectable hepatocellular carcinoma confirmed by pathological diagnosis (pathological tissue/cytology) or clinical diagnosis (dynamic enhanced MRI/dynamic enhanced CT scan), who have failed first-line treatment or lack/do not have first-line standard treatment conditions;
  • At least one measurable lesion in the liver (in accordance with RECIST version 1.1 standard);
  • Child-Pugh liver function score: A/B (≤ 7 points);
  • Expected survival time ≥ 12 weeks;
  • ECOG score of 0 or 1;
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  • Patients who have completed chemotherapy/radiation therapy for tumors for at least 4 weeks (those who have received chemotherapy with nitrosoureas and mitomycin for at least 6 weeks, those who have received small molecule targeted drugs (sorafenib, lovatinib) for at least 2 weeks), or those who have received chemotherapy/radiation therapy for at least 5 half-lives (the time limit shall be the longer); Surgical treatment>4 weeks, and the end time of the last intervention, radiotherapy, and ablation treatment>4 weeks;
  • Not using any anti-tumor drugs within 2 weeks before the first medication (including but not limited to the following modern Chinese medicine preparations with indications for liver cancer: Delisheng injection, Kanglaite injection or soft capsules, Aidi or Kangsaidi injection, elemene, Huaier granules, and Ganfule tablets);
  • Active hepatitis B patients should be controlled accordingly, and continue to take antiviral drugs and monitor liver function and hepatitis B virus load (for example, HBV DNA>104 copies/ml (2000IU/ml), and take antiviral drugs at least one week before use, and the virus quantity shows a downward trend);
  • If the main organs function normally, they meet the following standards:A. Blood routine examination: HGB ≥ 90 g/L; ANC ≥ 1.5 × 109/L; PLT ≥ 80 × 109/L;B. Biochemical examination: ALB ≥ 28 g/L; ALT and AST ≤ 5.0 × ULN; TBIL ≤ 1.5 × ULN; Creatinine ≤ 1.5 × ULN; The electrolyte is normal or normal after treatment or judged by the researcher to be abnormal without clinical significance;C. Urinary routine examination: Urinary protein ≤ 1+, such as urinary protein 2+, but 24-hour urinary protein<1.0g can be included in the group;. ECG results: QTcB<470ms for males and<480ms for females;
  • Those who agree to use effective non pharmacological contraceptive measures during the trial period;
  • The patient voluntarily signs a written informed consent form.

Who cannot join

  • Moderate or higher amounts of chest/ascites with clinical symptoms; Those who have received chest/ascites drainage within the past month; Only a small amount of chest/ascites found on imaging without symptoms can be included in the group;
  • Previous history of liver transplantation;
  • Obstructive jaundice and liver failure, resulting in hepatic encephalopathy; Tumor invading the inferior vena cava and forming a tumor thrombus in the inferior vena cava; If histological/pathological results can be provided, those with fibrous lamellar or sarcomatoid types cannot be included in the group;
  • Patients with other primary malignant tumors within 5 years, except for non melanoma skin cancer and cervical cancer in situ that have received sufficient treatment;
  • Individuals with active bleeding or abnormal coagulation function (PT>16s, APTT>43s, INR ≥ 2), bleeding tendency, or undergoing thrombolysis, anticoagulation, or antiplatelet therapy (except for those who require heparin due to PICC or deep venous catheterization); Those with significant bleeding/loss of blood (greater than 450ml) within 28 days;
  • Simultaneously taking drugs (such as amiodarone, quinidine, etc.) that may prolong QTc and/or induce torsade de pointe (Tdp);
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  • Pregnant or lactating women;
  • Any significant clinical and laboratory abnormalities that the researchers think affect the safety evaluation, such as: serious or medically important infections, uncontrolled diabetes (glycosylated hemoglobin>9%), patients with hypertension who cannot be reduced to the following range after treatment with two or less antihypertensive drugs (systolic pressure<160 mmHg, diastolic pressure<100 mmHg), peripheral neuropathy of grade II or above (CTC AE V5.0) Congestive heart failure, myocardial infarction within 6 months, etc;
  • Patients with unstable brain metastasis, meningeal metastasis, and mental disorders; Patients with stable brain metastasis after treatment (no need for treatment for at least 4 weeks) can be enrolled in the group;
  • Have a history of gastrointestinal bleeding within 3 months in the past or have a clear tendency for gastrointestinal bleeding, such as those who are known to have local active ulcer lesions or have positive fecal occult blood and continue to be positive after retesting for 3 days;
  • Patients with significantly abnormal glomerular filtration rate (creatinine clearance rate ≤ 60ml/min, calculated according to the CKD-EPI formula, see Appendix 19.2);
  • Active hepatitis C, that is, those who are anti HCV positive and HCV RNA positive, and those who turn negative for HCV RNA after treatment can be included in the group;
  • HIV antibody positive individuals; Treponema pallidum antibody positive;
  • Those who use any drug or substance known to strongly inhibit or induce CYP3A4 liver microsomal enzyme 28 days prior to the use of the study drug (see the section on prohibited drugs for details);
  • Subjects suspected to have a history of allergy to araC or similar drugs;
  • Symptoms of gout and blood uric acid>430umol/L;
  • Any known deficiency in glutathione metabolism or the need for high doses of acetaminophen/Tylenol ® (>1 g/day), or subjects who require or use medication doses that will consume glutathione;
  • Patients who are unable to undergo enhanced magnetic resonance imaging, such as those who are allergic to magnetic resonance imaging agents, those who have a heart pacemaker, aneurysm surgery, or those who have metal objects such as steel nails and plates in their bodies; Women with an intrauterine device (IUD) need to consider the situation;
  • Patients who have participated in clinical trials of other drugs and used the study drug within 28 days prior to the use of the study drug (calculated based on the last use of the study drug);
  • Subjects who the researchers believe have other factors that are not suitable for participation in this study.

Trial locations and contacts

1 site in 1 country.

Niu Junqi contact

13910866712

jianmingxu2014@163.com

China1 site, 1 recruiting

  • Fifth Medical Center of Chinese PLA General Hospital

    Beijing, Beijing Municipality

    Xu jianming, 13910866712, jianmingxu2014@163.com

    Recruiting

Other trials in China

About this study

Official title: A Multi-center, Open-label, Randomized Phase II Clinical Study to Evaluate the Efficacy and Safety of I.V.Infusion of MB07133 in Patients With Unresectable HCC

A randomized, open, multicenter clinical trial design was adopted, planned to be conducted in three stages, with 91 participants expected to be included in the study to evaluate the efficacy, tolerance, and safety of different doses of MB07133 in the treatment of unresectable advanced primary liver cancer.

Read the detailed description

first stage：The investigators plan to recruit 20 cases for mid dose group exploration: the injection MB07133600mg/m2/day group and the 1200mg/m2/day group, with 10 cases recruited for each group. The treatment cycle is 28 days, with each dose group receiving 7 days of medication and 21 days of rest per cycle.

second stage：Based on the data results of the first stage, the 1200mg/m2/day dose group MB07133 was selected for further expansion, with the same administration method as the first stage. Plan to recruit 30 subjects.

third stage：Based on the treatment results of H201110LC3, the 1800mg/m2/day dose group was selected for further expansion, and 40 subjects were recruited with the same administration method as the first stage.

Being tested
MB07133

What participants receive

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

  • MB07133Drug

    Evaluate the effectiveness and safety of different doses of MB07133

Study groups in NCT06141096
Study groupRoleWhat they receive
MB07133 600mg/m2/dayExperimentalNot described
Receives: Drug: MB07133
MB07133 1200mg/m2/dayExperimentalNot described
Receives: Drug: MB07133
MB07133 1800mg/m2/dayExperimentalNot described
Receives: Drug: MB07133

What is being measured

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

  1. PFS

    The time between the first medication and the occurrence (progression) or (death) of the tumor (for any reason).

    Measured: Screening period, every 2 cycles after treatment（each cycle is 28 days）until the date of first documented progression or date of death from any cause（No more than 24 cycles are expected）.

Secondary outcomes (2)

  1. OS

    The time between the first medication use and (for any reason) death

    Measured: Treatment period and follow-up period until the date of death from any cause（Up to 24 months after the last subject was enrolled）.

  2. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    Adverse events occurring after treatment, as well as laboratory tests, vital signs, and electrocardiogram

    Measured: From the beginning of medication to 35 days after the last administration

Timeline

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

  1. First posted21 Nov 2023
  2. Study start17 Jan 2020
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion31 Dec 2025 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
91 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06141096
Sponsor's protocol ID
H201110LC2
Acronym
MB07133
Status last verified
Nov 2023
First submitted
10 Nov 2023
Last updated
21 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MB07133 in people with Safety Issues and Effect of Drug, run by Xi'an Xintong Pharmaceutical Research 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 12 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 21 Nov 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Niu Junqi (13910866712, jianmingxu2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: Screening period, every 2 cycles after treatment（each cycle is 28 days）until the date of first documented progression or date of death from any cause（No more than 24 cycles are expected）.). 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 NCT06141096.

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 21 Nov 2023.

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