Clinical trial · Interventional
A Study of ILB2109 in Patients With Advanced Solid Malignancies
A Phase Ia, Multicenter, Open-label Study of ILB2109 in Patients With Advanced Solid Malignancies
NCT05278546CI-TRIAL-00082451active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ILB2109 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- There are nine escalating dose cohorts.
- interventionNames
- Drug: ILB2109
Primary outcomes (3)
- measure
- The Incidence of DLTs
- timeFrame
- At the end of Cycle 0 and 1 (Cycle 0 is 3 days, Cycle 1 is 21 days)
- description
- The incidence rate of Dose Limiting Toxicities (DLTs)
- measure
- MTD
- timeFrame
- 30 Months
- description
- Determining the maximum tolerated dose (MTD) for subsequent studies
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.