Status:
ACTIVE_NOT_RECRUITING
A Study of ILB2109 in Patients With Advanced Solid Malignancies
Lead Sponsor:
Innolake Biopharm
Collaborating Sponsors:
Shanghai East Hospital
Shandong Cancer Hospital and Institute
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This is a multicenter, open-label, phase Ia study to evaluate the safety, tolerability and preliminary efficacy of ILB2109, a A2a receptor antagonist, in patients with locally advanced or metastatic s...
Detailed Description
This is a two-part study consists of dose escalation and dose expansion. The dose escalation part adopts a 3+3 protocol design and consists of 5 cohorts. Based on the data obtained from the escalation...
Eligibility Criteria
Inclusion
- Histologically or cytological confirmed, solid, malignant tumor that is refractory to standard therapy or for which no standard of care regimen currently exists;
- At least one assessable tumor lesion according to RECIST v1.1 in dose escalation part of the study ; At least one measurable tumor lesion according to RECIST v1.1 in dose expansion part of the study;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Major organ functions are normal, meets pre-specified lab requirements;
- Females of reproductive age must have a negative serological hCG test during the screening period;
- Subjects of reproductive age (both male and female) must agree to use contraceptive methods from signing Informed Consent to 90 days post the last dose;
Exclusion
- Has received any investigational medicinal product or other systemic anticancer treatment within 4 weeks prior to the first dose of study treatment;
- Unable to take medication orally, or has impaired GI function;
- Has received systemic glucocorticoids (prednisone\>10 mg/ day or an equivalent dose of another drug of the same class) or other immunosuppressants within 14 days prior to the first dose of study treatment;
- Has received live, attenuated vaccines within 4 weeks prior to the first dose of study treatment;
- Has active infection that requires intravenous anti-infective therapy;
- History of HIV infection, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation;
- History of serious cardiovascular and cerebrovascular diseases;
- History of adverse effect from previous antineoplastic therapy that has not returned to CTCAE grade 5.0 ≤1;
- Cerebral parenchymal or meningeal metastasis;
- History of ≥ Grade 3 irAE or ≥ Grade 2 myocarditis from previous immune therapy;
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05278546
Start Date
April 11 2022
End Date
February 1 2025
Last Update
November 12 2024
Active Locations (2)
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1
Shandong Cancer Hospital and Institute
Jinan, Shandong, China, 25117
2
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200123