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Head and Neck CancerPhase 1/2NCT05955105

A Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies

A Phase 1/2 study testing ILB-2109 and Toripalimab in people with Head and Neck Cancer and Cervical Cancer, run by Innolake Biopharm 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a multicenter, open-label, phase Ib/IIa study. The first part of the study will evaluate the safety, tolerability and preliminary efficacy of ILB2109 and Toripalimab in patients with locally advanced or metastatic solid malignancies. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
ILB-2109 and Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
25 Jul 2023to 24 Jul 2026
Phase
Phase 1/2
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients between the ages of 18 and 80 years.
  • Patients with histologically or cytologically confirmed solid tumours that are advanced, metastatic and or progressive, for whom there is no effective standard therapy available.
  • Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤2.
  • Expected life expectancy ≥3 months.
  • Evaluable disease, either measurable on imaging, or with informative tumour marker(s), as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Eisenhauer, et al. 2009).
  • Laboratory values at Screening:
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  • Absolute neutrophil count ≥1.5 x 109/L; Platelets ≥75 x 109/L; Hemoglobin ≥ 90g/L; Total bilirubin <1.5 times the upper limit of normal; Aspartate aminotransferase (AST) ≤3 times the upper limit of normal, ≤ 5 times the upper limit of normal if subject has hepatic malignancies; Alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal, ≤ 5 times the upper limit of normal if subject has hepatic malignancies; Estimated glomerular filtration rate (GFR) of >50 mL/min (based on the Cockcroft-Gault formula; International Normalized Ratio (INR) and activated Partial Thromboplastin Time (aPTT) ≤1.5 times the upper limit of normal; Left Ventricular Ejection Fraction (LVEF) ≥ 50%; Corrected QT Interval by Fridericia Method: male<450ms, female<470ms; and
  • Negative human chorionic gonadotropin (hCG) test in women of childbearing potential.
  • Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control (e.g. barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study and for 90 days after final administration of ILB-2109, or the patient must be surgically sterile .
  • Ability to give written, informed consent prior to any study-specific Screening procedures.

Who cannot join

  • In the past 3 weeks: received systemic anti-tumor therapy, including chemotherapy, radiation, biologics, androgen, targeted therapy and immunotherapy with the following exceptions: i. received treatment containing nitrosoureas or mitomycin C in the past 6 weeks; ii. received oral fluorouracil or small molecule targeted therapy or Chinese Traditional Medicine (CTM) with anti-neoplasm indication in the past 2 weeks ;
  • In the past 4 weeks: received any other investigational treatment;
  • Gastrointestinal disease (e.g. Crohn's disease, ulcerative colitis, or short gut syndrome) that would impact on drug absorption;
  • Uncontrollable third-spacing of fluids;
  • Known CNS metastasis with clinical symptoms or the need of steroid treatment or CNS lesion ≥ 1.5cm or with the evidence of lesion enlargement in the past 4 weeks;
  • Severe cardiovascular diseases including symptomatic heart failure (NYHA Class II and above), unstable angina, arrythmia, myocardial infarction within the past 6 months, embolism or pulmonary embolism within the past 3 months;
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  • Having any risk factors of QT prolongation, including present or family history of long QT syndrome or using any medication with known QT prolongation effect;
  • Poor controlled chronic diseases, including poorly controlled diabetes mellitus (defined as HbA1c ≥ 8.5%), poorly controlled hypertension, has a history of hypertensive emergency or hypertensive encephalopathy, endocrine diseases that require systemic therapy;
  • Current diagnosis of interstitial pneumonia or a history of chronic emphysema, COPD, or TB infection;
  • Autoimmune diseases that required systemic therapy within the past 2 years, with the exception of vitiligo, asthma, atopic diseases and autoimmune thyroid diseases that are stable on thyroid replacement therapy;
  • Active infection with the need if IV antibiotic treatment;
  • Known HIV infection;
  • Active HBV infection (defined as positive HBsAg and HBV-DNA>500 IU/ml), active HCV infection (positive HCV antibody but HCV-RNA < lower limit of detection is allowed to participate);
  • Known syphilis infection;
  • Received systemic steroid at a dose greater or equivalent to 10mg of prednisone per day or other immune modulating treatments in the past 14 days;
  • Plan to receive live vaccine during the study period (4 weeks prior to the 1st dose till 6 months after the last dose);
  • Major surgery within the past 4 weeks;
  • Previous allogeneic bone marrow transplant or solid organ transplant;
  • Known history of psychiatric disease/alcohol or drug abuse that would affect subject's compliance to trial protocol;
  • Any unresolved toxicities from prior therapies higher than CTCAE grade 1 with the following exceptions: i. alopecia; ii. peripheral neuropathy; iii. thyroid function abnormalities that can be treated with replacement therapy;
  • Known history of CTCAE grade 3 and above irAE in previous immunotherapies;
  • Known allergy to ILB-2109 or Toripalimab;
  • Subjects who are currently pregnant or breastfeeding;
  • Other conditions that in the opinion of the investigator will make the subject unfit to participate in this trial;

Trial locations and contacts

1 site in 1 country.

Xue Wang contact

86-021-38863266

xue.wang@innolakebio.com

Yan Li, M.D. contact

86-021-38863266

yan.li@innolakebio.com

China1 site, 1 recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong

    Sun yuping

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib/IIa, Multicenter, Open-label Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies

This is a multicenter, open-label, phase Ib/IIa study. The first part of the study will evaluate the safety, tolerability and preliminary efficacy of ILB2109 and Toripalimab in patients with locally advanced or metastatic solid malignancies. The second part of the study will evaluate the efficacy of ILB2109 and Toripalimab in patients with selected advanced solid malignancies.

Read the detailed description

This is a two-part study consists of dose escalation and expansion in selected indications. The dose escalation part adopts a 3+3 protocol design and consists of 2 cohorts. Based on the data obtained from the escalation study, selected dose cohort will be expanded in 10 tumor types to further investigate the efficacy of the combination therapy. Subjects will be assessed for safety and efficacy outcomes at pre-specified time points.

Being tested
ILB-2109, Toripalimab
Medical subject headings
Head and Neck Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Triple Negative Breast Neoplasms, Ovarian Neoplasms, Sarcoma, Melanoma, Nasopharyngeal Carcinoma

What participants receive

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

  • ILB-2109Drug

    ILB-2109 tablets will be administered by mouth every day in 21-day cycles

  • ToripalimabDrug

    Toripalimab injection will be administered via IV every 21 days.

Study groups in NCT05955105
Study groupRoleWhat they receive
Treatment ArmExperimentalSubjects will receive ILB-2109 tablets and Toripalimab injection
Receives: Drug: ILB-2109; Drug: Toripalimab

What is being measured

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

  1. The Incidence of DLTs

    The incidence rate of Dose Limiting Toxicities (DLTs)

    Measured: Cycle 1 (21 days)

  2. MTD

    Determine the maximum tolerated dose (MTD) of ILB-2109 tablets

    Measured: 6 months

  3. RP2D

    Determine the recommended phase 2 dose (RP2D) when used in combination with Toripalimab for subsequent studies

    Measured: 6 months

  4. The Objective Response Rate (ORR)

    Observe the Objective Response Rate (ORR) of ILB-2109 tablets combined with Toripalimab in prespecified cohorts

    Measured: 36 months

Secondary outcomes (13)

  1. AE/TEAE/drug-related TEAE/irAE/SAE

    Incidence of AE/TEAE/drug-related TEAE/irAE/SAE graded by CTCAE 5.0

    Measured: 36 months

  2. Lab Abnormalities

    Incidence of lab/physcial/EKG/vitals abnormalities graded by CTCAE 5.0

    Measured: 36 months

  3. Peak Plasma Concentration (Cmax)

    Study the Peak Plasma Concentration of ILB-2109 tablets

    Measured: 36 months

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

    Study the Area under the plasma concentration versus time curve (AUC) of ILB-2109 tablets

    Measured: 36 months

  5. Half Life (T1/2)

    Study the Half Life (T1/2) of ILB-2109 tablets

    Measured: 36 months

  6. Time to maximum plasma concentration (Tmax)

    Study the Time to maximum plasma concentration (Tmax) of ILB-2109 tablets

    Measured: 36 months

  7. Clearance (CL)

    Study the Clearance (CL) of ILB-2109 tablets

    Measured: 36 months

  8. Volume of Distribution (Vd)

    Study the Volume of Distribution (Vd) of ILB-2109 tablets

    Measured: 36 months

  9. Progression Free Survival (PFS)

    Observe the Progression Free Survival (PFS) in prespecified cohorts

    Measured: 36 months

  10. Overall Survival (OS)

    Observe the Overall Survival (OS) in prespecified cohorts

    Measured: 36 months

  11. Duration of Response (DOR)

    Observe the Duration of Response (DOR) in prespecified cohorts

    Measured: 36 months

  12. Disease Control Rate (DCR)

    Observe the Disease Control Rate (DCR) in prespecified cohorts

    Measured: 36 months

  13. Time to Progression (TTP)

    Observe the Time to Progression (TTP) in prespecified cohorts

    Measured: 36 months

Timeline

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

  1. First posted21 Jul 2023
  2. Study start25 Jul 2023
  3. Primary completion25 Jan 2026 (estimated)
  4. Study completion24 Jul 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05955105
Sponsor's protocol ID
CILB2109A102
Status last verified
May 2024
First submitted
6 Jul 2023
Last updated
21 May 2024
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 1/2 study testing ILB-2109 and Toripalimab in people with Head and Neck Cancer and Cervical Cancer, 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 10 inclusion and 24 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 May 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 combined 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.

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 Xue Wang (86-021-38863266, xue.wang@innolakebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Incidence of DLTs (time frame: Cycle 1 (21 days)). The study lists 4 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 NCT05955105.

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 May 2024.

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