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.
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.
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;
Single group
ILB-2109
DrugILB-2109 tablets will be administered by mouth every day in 21-day cycles
Toripalimab
DrugToripalimab injection will be administered via IV every 21 days.
The Incidence of DLTs
The incidence rate of Dose Limiting Toxicities (DLTs)
MTD
Determine the maximum tolerated dose (MTD) of ILB-2109 tablets
RP2D
Determine the recommended phase 2 dose (RP2D) when used in combination with Toripalimab for subsequent studies
The Objective Response Rate (ORR)
Observe the Objective Response Rate (ORR) of ILB-2109 tablets combined with Toripalimab in prespecified cohorts
AE/TEAE/drug-related TEAE/irAE/SAE
Incidence of AE/TEAE/drug-related TEAE/irAE/SAE graded by CTCAE 5.0
Lab Abnormalities
Incidence of lab/physcial/EKG/vitals abnormalities graded by CTCAE 5.0
Peak Plasma Concentration (Cmax)
Study the Peak Plasma Concentration of ILB-2109 tablets
Area under the plasma concentration versus time curve (AUC)
Study the Area under the plasma concentration versus time curve (AUC) of ILB-2109 tablets
pCREB level in PBMC
Study the pharmacodynamic characteristics of ILB-2109 tablets, including the relationship between drug plasma concentration and the level of pCREB in PBMC.
Expression level of Adnosine Signature gene panel
Investigate potential biomarkers including the expression level of AdenoSig in tumor tissues
Tumor Mutational Burden
Investigate potential biomarkers including the TMB in tumor tissues
MSI Status
Investigate potential biomarkers including the MSI status in relationship to efficacy outcomes
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