BridgeMD
New treatment option for Head and Neck Cancer
Official title A Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies
ClinicalTrials.gov ID: NCT05955105
What this study is testing
What is ILB-2109?
ILB-2109 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for head and neck cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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...
You likely can't join if
- In the past 3 weeks: received systemic anti-tumor therapy, including chemotherapy, radiation, biologics, androgen, targeted therapy and immunotherapy...
- 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...
- Severe cardiovascular diseases including symptomatic heart failure (NYHA Class II and above), unstable angina, arrythmia, myocardial infarction...
See the full eligibility criteria
- 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: Absolute neutrophil count ≥1.5 x 109/L; Platelets ≥75 x 109/L; Hemoglobin ≥ 90g/L; Total bilirubin \ 50 mL/min (based on the Cockcroft-Gault formula; International Normalized Ratio (INR)...
- 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...
- Ability to give written, informed consent prior to any study-specific Screening procedures.
- 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...
- 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...
- 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...
- 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...
- Known history of CTCAE grade 3 and above irAE in previous immunotherapies;
- Known allergy to ILB-2109 or Toripalimab;
- people 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;
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.