A Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies
A Phase Ib/IIa, Multicenter, Open-label Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies
1 other identifier
interventional
200
1 country
1
Brief 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. The second part of the study will evaluate the efficacy of ILB2109 and Toripalimab in patients with selected advanced solid malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 head-and-neck-cancer
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2023
CompletedFirst Posted
Study publicly available on registry
July 21, 2023
CompletedStudy Start
First participant enrolled
July 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2026
ExpectedMay 21, 2024
May 1, 2024
2.5 years
July 6, 2023
May 19, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
The Incidence of DLTs
The incidence rate of Dose Limiting Toxicities (DLTs)
Cycle 1 (21 days)
MTD
Determine the maximum tolerated dose (MTD) of ILB-2109 tablets
6 months
RP2D
Determine the recommended phase 2 dose (RP2D) when used in combination with Toripalimab for subsequent studies
6 months
The Objective Response Rate (ORR)
Observe the Objective Response Rate (ORR) of ILB-2109 tablets combined with Toripalimab in prespecified cohorts
36 months
Secondary Outcomes (13)
AE/TEAE/drug-related TEAE/irAE/SAE
36 months
Lab Abnormalities
36 months
Peak Plasma Concentration (Cmax)
36 months
Area under the plasma concentration versus time curve (AUC)
36 months
Half Life (T1/2)
36 months
- +8 more secondary outcomes
Other Outcomes (8)
pCREB level in PBMC
36 months
Expression level of Adnosine Signature gene panel
36 months
Tumor Mutational Burden
36 months
- +5 more other outcomes
Study Arms (1)
Treatment Arm
EXPERIMENTALSubjects will receive ILB-2109 tablets and Toripalimab injection
Interventions
Eligibility Criteria
You may qualify 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 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 \<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.
You may not qualify if:
- 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;
- 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;
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shandong Cancer Hospital
Jinan, Shandong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin Li, M.D.
Shanghai East Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2023
First Posted
July 21, 2023
Study Start
July 25, 2023
Primary Completion
January 25, 2026
Study Completion (Estimated)
July 24, 2026
Last Updated
May 21, 2024
Record last verified: 2024-05