A Study of ILB2109 in Patients With Advanced Solid Malignancies

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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 solid malignancies.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innolake Biopharm
• Collaborators: Shandong Cancer Hospital and Institute; Shanghai East Hospital

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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;