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Solid TumorsPhase 1NCT06001684

Phase 1 Study of IBR854 in Locally Advanced Or Metastatic Solid Tumors

A Phase 1 study testing IBR854 Cell Injection in people with Solid Tumors, run by Imbioray (Hangzhou) Biomedicine 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 study is an open-label, phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of IBR854 cell injection in patients with unresectable, locally advanced, or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumors
What is being tested?
IBR854 Cell Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteChina
Study dates
1 Sep 2023to 26 Dec 2024
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

  • Subjects volunteer to participate in this clinical study, are fully aware of the study and have signed the Informed Consent Form (ICF). Subjects are willing to follow and able to complete all trial procedures.
  • Age: adult at the age of 18-75 (both inclusive), female or male.
  • Subjects with histologically or cytologically confirmed, unresectable, locally advanced or metastatic solid tumors (which can be diagnosed with the use of tumor markers in combination with imaging for specific advanced tumors, such as liver cancer) who have no current standard of care.
  • Eastern Cooperative Oncology Group (ECOG) score ≤2 and expected survival time >3 months.
  • According to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria, the subjects have at least one target lesion (non-lymph node lesion with major diameter ≥ 1.0cm or lymph node lesion with minor diameter ≥ 1.5 cm). A lesion that is within the field of previous radiotherapy could not be considered a target unless there is radiographic evidence of progression.
  • Organ function during screening should meet the following criteria:
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  • Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet (PLT) ≥75×10^9/L; Hemoglobin (Hb)≥80g/L (no blood transfusion or hematopoietic stimulator treatment within 7 days).
  • Alanine aminotransferase (ALT)≤3×ULN (Patients with liver metastasis: ≤5×ULN); Aspartate aminotransferase (AST)≤3×ULN (Patients with liver metastasis: ≤5×ULN);
  • Creatinine (Cr) ≤2× ULN; Creatinine clearance (Ccr) (to be calculated only when Cr > 2× ULN) > 50ml/min (Cockcroft-Gault formula);
  • Activated partial thrombin time (APTT) ≤1.5×ULN, International normalized ratio (INR) ≤1.5×ULN (Patients with anticoagulants: ≤ 2.5×ULN).
  • Subjects of reproductive age and their partners should agree to have no family planning and to use effective contraceptive methods for 6 months from signing the ICF until the last dose of the study drug is administered.

Who cannot join

  • Have received systemic antitumor therapy within 4 weeks or five half-lives of the drug (whichever is longer) before the first dose of the study drug: Systemic chemotherapy (2 weeks for oral fluorouracil, 6 weeks for mitomycin C and nitrosoureas), endocrine therapy, targeted therapy (2 weeks or 5 half-life for small molecule targeted therapy, whichever is longer), immunotherapy, radical radiotherapy, tumor embolization, Chinese herbal medicine for anti-tumor indications, etc. Or received palliative radiotherapy within 2 weeks before the first dose.
  • Toxic effects from previous antitumor therapy have not returned to grade 1 or less (other than alopecia or fatigue).
  • Any prior adoptive cellular immunotherapy.
  • Active brain metastases (one of the following criteria: clinical symptoms; A new diagnosis; Progression after previous local treatment).
  • Have undergone major organ surgery within 4 weeks prior to their first use of the study drug, or required elective surgery during the study period.
  • Long-term (≥ 3 days) treatment with a glucocorticoid (prednisone > 10 mg per day or equivalent) or another immunosuppressive agent is anticipated to be required during the study. Inhaled or topical steroid hormones are allowed in subjects without active autoimmune disease
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  • Have received a live or attenuated vaccine within 4 weeks before the first dose or plan to receive a live or attenuated vaccine during the study period.
  • Have severe infections that cannot be controlled.
  • Active hepatitis B, hepatitis C virus infection or HIV infection.
  • Have undergone an allogeneic bone marrow transplant or other organ transplant.
  • 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 that was well controlled with hormone replacement therapy, hypothyroidism, skin conditions that did not require systemic therapy (e.g., vitiligo), and other conditions that were well controlled and that the investigator determined were less likely to recur (e.g., childhood asthma in remission).
  • 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;
  • Prolonged QT interval corrected with Fridericia's method (QTcF) (>450 ms in men; >470 ms for women)
  • 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.
  • Clinically significant chronic obstructive pulmonary disease or other moderate to severe chronic respiratory disease developed within 6 months.
  • Have other malignant tumors in the past 3 years, excluding skin basal cell carcinoma, ductal carcinoma in situ and cervical carcinoma in situ with a radical surgery.
  • Pregnant or lactating women.
  • Have mental disorders or a history of alcohol, drug or drug abuse within one year.
  • Have participated in other clinical trials and received any unmarketed investigational drug or treatment within 4 weeks prior to first use of the study drug.
  • Allergic to the main components of the study drug.
  • The investigator considered that the subjects had a history of other serious systemic diseases or other reasons that made them unsuitable for the study.
  • Unsuitable for participation in this study considered by the investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: A Phase I Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IBR854 Cell Injection in Patients With Unresectable Locally Advanced Or Metastatic Solid Tumors

This study is an open-label, phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of IBR854 cell injection in patients with unresectable, locally advanced, or metastatic solid tumors.

Read the detailed description

This study is a dose escalation study which adopts the 3+3 dose escalation design protocol. The dose is respectively 3.0×10^9 cells, 5.0×10^9 cells and 7.0×10^9 cells. The administration is performed on day 1 and day 8 of each cycle (21 days). 3-6 subjects will be enrolled at every dose level. The first and second subjects in the same group shall be enrolled at an interval of at least 7 days, for the purpose of ensuring their safety. Only when the dose-limiting toxicity (DLT) of all subjects in the previous dose group was observed can the enrollment of the next dose group get started.

Conditions
Solid Tumors
Being tested
IBR854 Cell Injection

What participants receive

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

  • IBR854 Cell InjectionBiological

    The minimum initial dose is 3.0×10^9 cells and then escalate to 5.0×10^9 cells and 7.0×10^9 cells. Every 21 days is one cycle, and intravenous infusion is performed on day 1 and day 8 of each cycle.

Study groups in NCT06001684
Study groupRoleWhat they receive
IBR854 Cell InjectionExperimentalThe minimum initial dose is 3.0×10^9 cells and then escalate to 5.0×10^9 cells and 7.0×10^9 cells. Every 21 days is one cycle, and intravenous infusion is performed on day 1 and day 8 of each cycle.
Receives: Biological: IBR854 Cell Injection

What is being measured

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

  1. Incidence of dose limiting toxicity (DLTs)

    To collect dose limiting toxicities (DLTs) occurring within 21 days after the first dose

    Measured: From day1 to day 21

  2. The incidence and severity of adverse events (AEs)

    To evaluate the safety of IBR854 cell injection

    Measured: From day 1 to day 90 after the first dose

Secondary outcomes (7)

  1. Objective response rate (ORR)

    To determine the anti-tumor effectivity of IBR854 cell injection

    Measured: 1 year

  2. Disease control rate (DCR)

    To determine the anti-tumor effectivity of IBR854 cell injection

    Measured: 1 year

  3. Duration of remission (DOR)

    To determine the anti-tumor effectivity of IBR854 cell injection

    Measured: 1 year

  4. Progression-free survival (PFS)

    To determine the anti-tumor effectivity of IBR854 cell injection

    Measured: 1 year

  5. Overall survival (OS)

    To determine the anti-tumor effectivity of IBR854 cell injection

    Measured: 1 year

  6. The number of IBR854 cells

    Blood samples will be collected at specified time points to detect the number of IBR854 cells in peripheral blood

    Measured: 1 year

  7. Anti-CAR antibodies

    Blood samples will be collected at specified time points to detect anti-CAR(anti-5T4 mAb) antibodies

    Measured: 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 posted21 Aug 2023
  2. Study start1 Sep 2023
  3. Primary completion26 Dec 2024
  4. Study completion26 Dec 2024

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
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06001684
Sponsor's protocol ID
IBR854-101
Status last verified
Jul 2026
First submitted
8 Aug 2023
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sun L, Ma P, Miao Z, Su N, Bian J, Wang S, Li N. Safety and feasibility of 5T4 antibody-coupled allogeneic NK cell therapy for solid tumors: a first-in-human phase 1 trial. Cancer Immunol Immunother. 2026 Jul 6. doi: 10.1007/s00262-026-04481-1. Online ahead of print.

    PubMed 42406083

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IBR854 Cell Injection in people with Solid Tumors, run by Imbioray (Hangzhou) Biomedicine 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 11 inclusion and 25 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 2 Jul 2026. 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?

Incidence of dose limiting toxicity (DLTs) (time frame: From day1 to day 21). 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 NCT06001684, which also lists 1 linked publication.

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 2 Jul 2026.

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