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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: ILB2109

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yan Li, M.D.; Phone Number: +86(021)38863266; Email: yan.li@innolakebio.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 25117
      • Recruiting
      • Shandong Cancer Hospital and Institute
      • Contact: Yuping Sun, M.D.
      • Principal Investigator: yuping Sun, M.D.
      • Principal Investigator: Jiasheng Bian, M.D.
  • Shanghai
    • Shanghai, Shanghai, China, 200123
      • Recruiting
      • Shanghai East Hospital
      • Contact: Jin Li, M.D.
      • Principal Investigator: Jin Li, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; There are nine escalating dose cohorts.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Incidence of DLTs	The incidence rate of Dose Limiting Toxicities (DLTs)	At the end of Cycle 0 and 1 (Cycle 0 is 3 days, Cycle 1 is 21 days)
MTD	Determining the maximum tolerated dose (MTD) for subsequent studies	30 Months
RD	Determining the Recommended Dose (RD) for subsequent studies	30 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcomes	Determining the incidence rate, type and severity of Treatment Emergent Adverse Event (TEAE), Treatment Emergent Serious Adverse Event (TESAE), and lab abnormalities (hematology and major organ function lab tests) based on NCI-CTCAE 5.0;	From Informed Consent to 28 days after the last dose, expected follow-up period 6 months
Time To Response (TTR)	Time from the start of treatment to the first objective tumor response	Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
Duration Of Response (DOR)	The time from response to progression/death	Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
Clinical Benefit Response (CBR)	The total percentage of patients who achieved a complete response, partial response, or had stable disease for 6 months or more.	Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
Maximum Plasma Concentration (Cmax)	Characterize the single-dose and multiple-dose plasma concentration of ILB2109	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)
Area Under the plasma drug concentration-time Curve (AUC)	Characterize the single-dose and multiple-dose plasma concentration of ILB2109	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)
Objective Response Rate (ORR)	n tumor treatment, the proportion of patients whose tumor volume has shrunk to a predetermined value and can be maintained for a certain period of time. It includes the proportion of patients with complete remission (CR) and partial remission (PR) to the total number of evaluable cases.	Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
Progression Free Survival (PFS)	The time from randomization of patients to the onset of disease progression.	Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
Overall Survival (OS)	The time from randomization to death for any reason	Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
1-Year OS	The probability of a survival time of 1 year after treatment for this disease	Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of Downstream Signaling Protein	Characterize the relationship between the plasma concentration of ILB2109 and the level of a downstream signaling protein to evaluate the pharmacodynamics of ILB2109.	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)

Collaborators and Investigators

• Sponsor: Innolake Biopharm
• Collaborators: Shandong Cancer Hospital and Institute; Shanghai East Hospital
• Investigators: Principal Investigator: Jin Li, M.D., Shanghai East Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 19, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CILB2109A101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes