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Advanced Primary Liver CancerEarly Phase 1NCT05411757

IBR900 Cell Injection Combined With Lenvatinib or Bevacizumab in the Treatment of Advanced Primary Liver Cancer

A Early Phase 1 study testing IBR900 combined with Lenvatinib and IBR900 combined with Bevacizumab in people with Advanced Primary Liver Cancer, run by Shandong Public Health Clinical Center.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is an open-label, nonrandomized investigator-initiated clinical trial to evaluate the safety, tolerability, and efficacy of IBR900 cell injection in combination with Lenvatinib or bevacizumab in subjects with advanced primary liver cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Primary Liver Cancer
What is being tested?
IBR900 combined with Lenvatinib and IBR900 combined with Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
30 Jun 2022to 30 Dec 2023
Phase
Early 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

  • Male or female, age≥18 and ≤75 years old.
  • Subjects with stage IIb, # or IV unresectable / advanced primary hepatocellular carcinoma, intrahepatic cholangiocarcinoma or mixed hepatocellular cholangiocarcinoma diagnosed in accordance with the Guidelines for Diagnosis and Treatment of Primary Liver Cancer of CSCO(2020 Edition).
  • Having ≥ 1 measurable lesion in accordance with the modified Response Evaluation Criteria in Solid Tumors (mRECIST) (lesions located in the field of previous radiation therapy cannot be used as target lesions unless there is imaging evidence that the lesion has progressed or persisted three months after radiation therapy).
  • Have a performance status of 0 or 2 on the ECOG Performance Score, life expectancy ≥12 weeks.
  • Male and female subjects of childbearing age and their partners must agree to take effective birth controls (hormone, barrier method or abstinence, etc.) from signing the ICF to 6 months after the last administration.
  • Subjects should voluntarily participate in this clinical study, are fully aware of the study, have signed the Informed Consent Forms, and are willing to follow and able to complete all trial procedures.

Who cannot join

  • Received systemic anti-tumor therapy within 4 weeks prior to the first administration, including chemotherapy, immunotherapy, radical radiotherapy, etc.; received palliative radiotherapy within 2 weeks prior to the first administration; or the adverse events caused by previous anti-tumor therapy have not recovered to ≤Grade 1 (except for alopecia).
  • Have known central nervous system metastases with clinical symptoms.
  • Received any adoptive cellular immunotherapy within 6 months prior to the first administration.
  • Have undergone major organ surgery (excluding needle biopsy or surgery related to this indication) within 4 weeks prior to their first administration of the study drug, or required elective surgery during the study period.
  • Have received or expected to receive glucocorticoids (prednisone >10 mg daily or equivalents) or other immunosuppressive medications within 14 days prior to the first administration. Note: For subjects without active autoimmune disorder, inhaled or topical steroid hormone or equivalent dose of prednisone ≤ 10 mg/day is allowed, and glucocorticoid is allowed for short-term (≤ 7 days) preventive treatment (e.g. contrast media allergy) or for the treatment of non-autoimmune disorder (e.g. delayed type hypersensitivity to contact allergens).
  • Received live or attenuated vaccine within 4 weeks prior to the first administration or plan to receive live or attenuated vaccine during the study period.
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  • Patients with severe infections that cannot be controlled.
  • Patients with a known history of human immunodeficiency virus (HIV) active infection.
  • Have active autoimmune diseases or have had autoimmune diseases that are likely to recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.). Except in the following cases: type 1 diabetes well controlled with hormone replacement therapy, hypothyroidism, skin conditions not requiring systemic therapy (such as vitiligo), and other conditions that are well controlled and that are less likely to relapse as by the investigator (such as resolved childhood asthma).
  • Organ function during screening should meet the following criteria:
  • Absolute neutrophil count (ANC)<1.5×10^9/L, platelet (PLT)<75×10^9/L, hemoglobin (Hb)<80g/L, (blood transfusion, platelet and colony stimulating factor therapy are not allowed within 2 weeks before the test);
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)>5 times the upper limit of normal (ULN), and total serum bilirubin>2.5 times the upper limit of normal (ULN);
  • Creatinine(Cr)>1.5×ULN, and creatinine clearance rate(Ccr) ≤ 60ml/min (estimated according to Cockcroft-Gault formula). Note: Ccr to be calculated only when Cr >1.5×ULN;
  • International normalized ratio (INR) ≤ 2.0×ULN, activated partial thrombin time (APTT) >1.5×ULN.
  • Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
  • There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia, and Ⅱ-Ⅲ degree atrioventricular block, which need clinical intervention;
  • The mean QT interval corrected by Fridericia method (QTcF) is prolonged (male>450ms, female>470ms);
  • Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or above cardiovascular and cerebrovascular events occurring within 6 months before the first administration;
  • Patients with heart failure or left ventricular ejection fraction (LVEF) < 50% in the New York Heart Association (NYHA) classification ≥II;
  • Hypertension beyond clinical control;
  • Subjects with previous or current interstitial lung disease, pneumoconiosis, radiation pneumonia, severe impairment of pulmonary function that may interfere with the detection and treatment of suspected drug-related pulmonary toxicity. Or uncontrolled systemic diseases, including diabetes, etc.
  • Had other malignant tumors in the past 3 years, except for any type of carcinoma in situ that has been cured in the past and cured skin basal cell carcinoma or skin squamous cell carcinoma.
  • Pregnant women or lactating women.
  • Have a history of drug abuse.
  • Patients with a history of serious dementia, mental status changes or any history of mental disorder, incapacity or limited capacity.
  • Have participated in other clinical trials and received any unmarketed investigational drug or treatment within 4 weeks prior to the first administration.
  • Patients who have received anti-tumor treatment with lenvatinib and bevacizumab.
  • According to the judgment of the investigators, other factors that may make the subjects unsuitable for the study.

Trial locations and contacts

No sites are listed yet.

Xiaodi Li contact

+8617860107786

sdgwzx2022@163.com

About this study

Official title: A Single-Arm, Open-Label Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of IBR900 Cell Injection Combined With Lenvatinib or Bevacizumab in the Treatment of Subjects With Advanced Primary Liver Cancer

This is an open-label, nonrandomized investigator-initiated clinical trial to evaluate the safety, tolerability, and efficacy of IBR900 cell injection in combination with Lenvatinib or bevacizumab in subjects with advanced primary liver cancer.

Read the detailed description

Two treatment groups are set up in this study. The first treatment group is IBR900 cell injection combined with Lenvatinib. The second treatment group is IBR900 cell injection combined with bevacizumab. Each cycle of the two treatment groups is 21 days. After 4 cycles of treatment, if the investigator judges that the subjects may benefit from continuing treatment, the subjects can continue to receive more cycles of treatment. 6 subjects are enrolled in each treatment group, and the group assignment of subjects is determined by the investigator.

For subjects who have previously received Lenvatinib, they will not be able to continue to receive Lenvatinib after entering the study, but can be treated in combination with bevacizumab. For subjects who have previously received bevacizumab, they will not be able to continue to receive bevacizumab after entering the study, but can be treated in combination with Lenvatinib.

Being tested
IBR900 combined with Lenvatinib, IBR900 combined with Bevacizumab

What participants receive

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

  • IBR900 combined with LenvatinibCombination product

    IBR900 cell injection: 4.0×10^9 cells, D1,D3 of each cycle. Lenvatinib: body weight ≥ 60kg, 12mg/qd; body weight < 60kg, 8mg/qd; administered continuously from D5 of the first cycle

  • IBR900 combined with BevacizumabCombination product

    IBR900 cell injection: 4.0×10^9 cells, D1,D3 of each cycle. Bevacizumab:15mg/kg, D1 of each cycle.

Study groups in NCT05411757
Study groupRoleWhat they receive
IBR900 cell injectionExperimentalIBR900 Cell Injection Combined With Lenvatinib or Bevacizumab
Receives: Combination Product: IBR900 combined with Lenvatinib; Combination Product: IBR900 combined with Bevacizumab

What is being measured

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

  1. Adverse Events (AEs)

    The incidence and severity of adverse events assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0, and the correlation between adverse events and IBR900 cell injection.

    Measured: From day 1 to day 90 after the last infusion

Secondary outcomes (5)

  1. Objective response rate (ORR)

    The proportion of subjects with complete and partial tumor remissions after treatment

    Measured: Up to 1 year after infusion

  2. Progression-free survival (PFS)

    The time from the beginning of treatment to the onset of tumor progression or death from any cause

    Measured: Up to 1 year after infusion

  3. Overall survival (OS)

    From the beginning of treatment to the time of death from any cause

    Measured: Up to 5 year after infusion

  4. Disease control rate (DCR)

    Proportion of subjects with complete, partial response and stable disease

    Measured: Up to 1 year after infusion

  5. Best of response (BOR)

    The rate of best of disease response recorded from the beginning of study treatment to disease progression, recurrence, or death.

    Measured: Up to 1 year after infusion

Timeline

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

  1. First posted9 Jun 2022
  2. Study start30 Jun 2022 (estimated)
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion30 Dec 2023 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05411757
Sponsor's protocol ID
IBR900-T02
Status last verified
Jun 2022
First submitted
1 Jun 2022
Last updated
9 Jun 2022
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 Early Phase 1 study testing IBR900 combined with Lenvatinib and IBR900 combined with Bevacizumab in people with Advanced Primary Liver Cancer, run by Shandong Public Health Clinical Center.

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 6 inclusion and 28 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 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Xiaodi Li (+8617860107786, sdgwzx2022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) (time frame: From day 1 to day 90 after the last infusion). 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 NCT05411757.

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 9 Jun 2022.

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