Clinical trial NCT05278546: A Study of ILB2109 in Patients With Advanced Solid Malignancies
Official title: A Phase Ia, Multicenter, Open-label Study of ILB2109 in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Innolake Biopharm
Sponsor class: INDUSTRY
Collaborators: name: Shanghai East Hospital
name: Shandong Cancer Hospital and Institute
First posted: 2022-03-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: The Incidence of DLTs
timeFrame: At the end of Cycle 0 and 1 (Cycle 0 is 3 days, Cycle 1 is 21 days)
measure: MTD
timeFrame: 30 Months
measure: RD
timeFrame: 30 Months
Secondary outcomes:
measure: Safety Outcomes
timeFrame: From Informed Consent to 28 days after the last dose, expected follow-up period 6 months
measure: Objective Response Rate (ORR)
timeFrame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
measure: Progression Free Survival (PFS)
timeFrame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
measure: Overall Survival (OS)
timeFrame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
measure: 1-Year OS
timeFrame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
measure: Time To Response (TTR)
timeFrame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
measure: Duration Of Response (DOR)
timeFrame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
measure: Clinical Benefit Response (CBR)
timeFrame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Blood samples will be collected at pre-specified time points in Cycles 0, 1 and 2 (Cycle 0 is 3 days, Cycles 1&2 each is 21 days)
measure: Area Under the plasma drug concentration-time Curve (AUC)
timeFrame: Blood samples will be collected at pre-specified time points in Cycles 0, 1 and 2 (Cycle 0 is 3 days, Cycles 1&2 each is 21 days)
Other outcomes:
measure: Plasma Concentration of Downstream Signaling Protein
timeFrame: Blood samples will be collected at pre-specified time points in Cycles 0 and 1 (Cycle 0 is 3 days, Cycle 1 is 21 days)
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute
state: Shandong
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital
name: Jin Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: