A Study of ILB2109 in Patients With Advanced Solid Malignancies

NCT ID: NCT05278546

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-11
• Study Completion Date: 2025-02-28

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 solid malignancies.

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 study, selected cohorts will be expanded to further investigate the safety and efficacy of the study drug. The escalation part consists of a single-dose cycle (Cycle 0) followed by multiple-dose cycles (Cycle 1 and above). Subjects will be assessed for safety and efficacy outcomes at pre-specified time points.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

There are nine escalating dose cohorts.

Group Type: EXPERIMENTAL

ILB2109

Intervention Type: DRUG

ILB2109 tablets by mouth once per day at dosages prespecified by the protocol. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Interventions

ILB2109

ILB2109 tablets by mouth once per day at dosages prespecified by the protocol. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Intervention Type: DRUG

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai East Hospital

OTHER

Sponsor Role: collaborator

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: collaborator

Innolake Biopharm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital

Locations

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CILB2109A101

Identifier Type: -

Identifier Source: org_study_id