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Advanced Solid TumorPhase 1NCT06426680

A Study of the ILB-3101 in Patients with Advanced Solid Tumors

A Phase 1 study testing ILB-3101 in people with Advanced Solid Tumor, run by Innolake Biopharm 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

ILB-3101 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of ILB-3101 in Chinese advanced solid tumor patients. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
ILB-3101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteChina
Study dates
30 Oct 2024to Mar 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have signed informed consent forms voluntarily.
  • 18-80 years old.
  • Having an ECOG performance status score of 0 or 1.
  • With an expected survival of more than 12 weeks.
  • Diagnosed histologically or cytologically with local advanced or metastatic solid cancer, and under one of following situations: standard treatment-refractory (disease progression or no response), treatment-resistant, unable to receive treatment, or the standard treatment is unavailable.
  • Need to provide archived tumor tissue samples (Formalin fixed or paraffin embedded tissue blocks or at least 5 unstained sections); During the dose escalation stage, for subjects who are unable to provide tumor samples or have insufficient samples, the decision to enroll may be made based on specific circumstances after discussion with the sponsor.
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  • At least one assessable tumor lesion is present during the dose escalation phase, and according to RECIST version 1.1, at least one measurable tumor lesion is present during the dose escalation phase (CRPC can be determined based on PCWG3).
  • Having sufficient bone marrow, liver, and kidney functions (based on the normal value of the clinical trial site):
  • Absolute neutrophil count (ANC) ≥ 1.5×109/L.
  • Platelets ≥ 75×109/L.
  • Hemoglobin ≥ 90g/L.
  • Total serum bilirubin ≤ 1.5×upper limit of normal (ULN).
  • Without liver metastases, ALT, AST ≤ 2.5×ULN; with liver metastases, ALT, AST ≤ 5×ULN.
  • Serum creatinine ≤1.5 × ULN.
  • Creatinine clearance rate (CrCl) (creatinine only ˃ Calculation required for 1.5 × ULN ≥50 mL/min (Calculate according to Cockcroft Fault formula),
  • International Normalized Ratio (INR) ≤ 1.5×ULN, APTT ≤ 1.5×ULN.
  • Echocardiographic LVEF (left ventricular ejection fraction) ≥ 50%.
  • QT interval corrected by Fridericia method (QTcF) Male<450ms; Female<470ms.
  • The serum pregnancy test results of female subjects of childbearing age are negative.
  • Male or female patients of childbearing potential must agree to use effective methods of contraception (such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives and intrauterine devices) during the study period and within 90 days after the last dosing.

Who cannot join

  • Within 3 weeks prior to the first administration, systemic anti-tumor therapy has been received, including chemotherapy, curative radiotherapy (palliative radiotherapy for a single lesion within 3 weeks prior to enrollment is allowed, and radiotherapy is not allowed for measurable lesions before enrollment unless it is confirmed that the lesion has progressed after radiotherapy), biological therapy, immunotherapy, etc., except for the following:
  • Received urea nitrite or mitomycin C within 6 weeks prior to the first use of the study drug.
  • Oral administration of fluorouracil or small molecule targeted drugs within 2 weeks prior to the first use of the investigational drug or within 5 half-lives of the drug (whichever is longer).
  • Individuals who have received endocrine therapy within 2 weeks prior to the first use of the investigational drug.
  • Traditional Chinese patent medicines and simple preparations or traditional Chinese medicine with anti-tumor indication within 1 week before the first use of the study drug.
  • Patients who received other clinical trial drug within 4 weeks before the first dosing.
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  • Within 3 years prior to the first trial drug treatment, the patient had other active malignant tumors, except for the tumors participating in this study and other locally cured tumors (such as basal skin cancer, papillary thyroid cancer, or any type of in situ cancer that has been completely removed, such as cervical in situ cancer, ductal carcinoma in situ, etc.).
  • The presence of clinically uncontrollable pleural/abdominal effusion, pericardial effusion, determined by the investigators as unsuitable for inclusion.
  • Suffering from central nervous system metastasis and/or cancerous meningitis. Except for asymptomatic or asymptomatic central nervous system metastases that have been clinically controlled but are judged stable by investigators, the following conditions must also be met:
  • Stable clinical symptoms for at least 4 weeks before receiving trial drug treatment.
  • No evidence of central nervous system disease progression was found in imaging examinations within 4 weeks prior to the first trial drug treatment.
  • Antiepileptic drugs have been discontinued at least 2 weeks prior to the first trial drug treatment, and the dosage of prednisone is ≤ 10mg/day or equivalent dose of steroids.
  • For patients with intracranial lesions, if they have received treatment (such as radiotherapy) before the first trial drug treatment, elution should be ≥ 2 weeks. Cancer induced encephalitis should be excluded regardless of its stable clinical condition.
  • Receiving drug therapy known to prolong the QT interval or potentially lead to torsade de pointe ventricular tachycardia; Or continue to receive these medications during the research period.
  • Acute coronary syndrome occurring within the past 6 months, including myocardial infarction, unstable angina, symptomatic congestive heart failure (New York Heart Association classification II-IV), aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events; Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III-degree atrioventricular block, etc.
  • Suffering from clinically uncontrollable diseases, including but not limited to severe diabetes (diabetes ketoacidosis or hyperglycemia hyperosmolality occurred within 6 months before the first administration, and the detection value of glycosylated hemoglobin in the screening period was ≥ 7.5%); Refractory hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100mmHg after optimal medical treatment within the first month of screening) or a history of hypertensive crisis or hypertensive encephalopathy.
  • Individuals with previous or current interstitial lung disease (excluding radiation pneumonia that does not require hormone therapy).
  • Evidence of persistent uncontrolled systemic bacterial, fungal, or viral infections (including HIV infection, HIV antibody positive; syphilis infected individuals) and current need for intravenous anti infection treatment.
  • Provisions on hepatitis B and hepatitis C: if hepatitis B surface antigen (HBsAg) is positive, and HBV-DNA>2000 IU/ml or 104 copies/ml, hepatitis B virus infected persons should receive antiviral treatment according to local guidelines and standards and are willing to receive antiviral treatment throughout the study period; Hepatitis C antibody positive, and HCV RNA higher than the upper limit of normal values in the study site;
  • Within 14 days prior to the first administration, systemic corticosteroids (prednisone>10mg/day or equivalent doses of similar drugs) or other immunosuppressive treatments have been received, except for the following:
  • Use local, ocular, intra-articular, intranasal, and inhaled corticosteroids for treatment.
  • short term use of glucocorticoids for preventive treatment (such as preventing contrast agent allergies).
  • Within 4 weeks before the first administration or planned to receive attenuated live vaccines during the study period.
  • Having undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to the first administration or requiring elective surgery during the trial period.
  • Individuals who have received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past.
  • Known to have alcohol or drug dependence.
  • Individuals with mental disorders or poor compliance.
  • The adverse reactions of previous anti-tumor treatments have not yet recovered to CTCAE5.0 ≤ Grade 1 (excluding toxicity judged by the investigators to have no safety risk, such as hair loss, grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement therapy, etc.);
  • Known to cause clinically significant allergic reactions to the active ingredients and excipients, antibodies, and other monoclonal antibodies.
  • Pregnant (positive pregnancy test prior to dosing) or breast-feeding women.
  • The investigators believe that the subjects are not suitable to participate in this clinical study due to other reasons.

Trial locations and contacts

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

Yan Li, MD contact

18610580233

yan.li@innolakebio.com

Xue Wang contact

xue.wang@innolakebio.com

China1 site, 1 recruiting

  • Fundan University Shanghai Cancer Center

    Shanghai

    Zhang Jian, Doctor

    Recruiting

Other trials in China

About this study

Official title: Phase I/II Study of the ILB-3101 in Patients with Advanced Solid Tumors

ILB-3101 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of ILB-3101 in Chinese advanced solid tumor patients.

Read the detailed description

This is an open-label, multi-center, dose-escalation and expansion, first-in-human phase 1 study in Chinese adult participants with locally advanced or metastatic solid tumors. This study will consist of two parts: A Part I dose escalation stage and a Part II dose expansion stage.

The objectives of this study are to evaluate the safety, tolerability, PK and preliminary anti-tumor activity, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of ILB-3101.

Part I: Participants with advanced cancer are eligible for dose escalation study if they have progressed on or intolerant to available standard therapies, or no standard or available curative therapy exists. The dose escalation will include an initial accelerated titration design followed by 3+3 design.

Part II: Enrollment into dose expansion will begin after identification of the MTD or MAD in Phase I. The dose expansion study will be conducted in populations with the following indications: ovarian cancer, small cell lung cancer, head and neck squamous cell carcinoma, soft tissue sarcoma (including uterine sarcoma), triple negative breast cancer, esophageal squamous cell carcinoma, prostate cancer, etc..

All patients will be carefully followed for adverse events during the study treatment and for 28 days after the last dose of study drug. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists.

Being tested
ILB-3101

What participants receive

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

  • ILB-3101Biological

    There are eight escalating dose cohorts.

Study groups in NCT06426680
Study groupRoleWhat they receive
ILB-3101ExperimentalThere are eight escalating dose cohorts. Intravenous (IV) administration of ILB-3101 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Receives: Biological: ILB-3101

What is being measured

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

  1. DLT

    Dose-limiting toxicity for ILB-3101

    Measured: Up to day 21 from the first dose

  2. MTD

    Maximum tolerated dose (MTD) for ILB-3101

    Measured: Up to day 21 from the first dose

Secondary outcomes (10)

  1. ORR

    Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.

    Measured: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months

  2. Incidence and severity of adverse events (AEs)

    AE assessed by investigator exclusively related to subject's underlying disease or medical condition [graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc.

    Measured: From the first dose through 90 days post end of treatment

  3. Percentage of participants with antibodies to ILB-3101 in serum

    Serum samples were collected for the determination of anti-drug antibody (ADA) at designated time points.

    Measured: From pre-dose to 90 days post end of treatmen

  4. Observed maximum plasma concentration (Cmax) of ILB-3101 in participants with advanced solid tumor

    Cmax will be obtained following administration of the first dose of ILB-3101 during the first cycle.

    Measured: From pre-dose to 21 days after the first dose on Cycle 1

  5. Time to reach maximum plasma concentration (Tmax) of ILB-3101 following the first dose in participants with advanced solid tumor

    Tmax will be obtained following administration of the first dose of ILB-3101 during the first cycle.

    Measured: From pre-dose to 21 days after the first dose on Cycle 1

  6. Terminal half-life (T1/2) of ILB-3101 following IV dose in participants with advanced solid tumor

    Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.

    Measured: From pre-dose to 21 days after the first dose on Cycle 1

  7. Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of ILB-3101

    Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration was no less than the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.

    Measured: From pre-dose to 21 days after the first dose on Cycle 1

  8. Duration of response (DOR) determined by investigators according to RECIST 1.1

    DoR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used [Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].

    Measured: From the first dose up to PD or death, whichever came first, assessed up to 24 months

  9. Disease control rate (DCR) determined by investigators according to RECIST 1.1

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) [Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose].

    Measured: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months

  10. Progression-free survival (PFS) determined by investigators according to RECIST 1.1

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). PFS was defined as the time from random assignment (dose expansion stage) or first dose (dose escalation stage) to PD or death from any cause.

    Measured: From the randomization/first dose up to PD or death, whichever came first, assessed up to 24 months

Timeline

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

  1. First posted23 May 2024
  2. Study start30 Oct 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionMar 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06426680
Sponsor's protocol ID
CILB3101A101
Status last verified
Dec 2024
First submitted
19 May 2024
Last updated
9 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 ILB-3101 in people with Advanced Solid Tumor, run by Innolake Biopharm 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 20 inclusion and 31 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 9 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 Yan Li, MD (18610580233, yan.li@innolakebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: Up to day 21 from the first 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 NCT06426680.

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 Dec 2024.

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