A Study of ILB2109 in Patients With Advanced Solid Malignancies

NCT05278546 | Active Not Recruiting Phase 1

• 1 other identifier: CILB2109A101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Safety Outcomes

  From Informed Consent to 28 days after the last dose, expected follow-up period 6 months

• Objective Response Rate (ORR)

  Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months

• Progression Free Survival (PFS)

  Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months

• Overall Survival (OS)

  Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months

• 1-Year OS

  Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months

Other Outcomes (1)

• Plasma Concentration of Downstream Signaling Protein

  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)

Study Arms (1)

Treatment Arm

EXPERIMENTAL

There are nine escalating dose cohorts.

Drug: ILB2109

Interventions

ILB2109 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.

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Innolake Biopharm: lead
• Shanghai East Hospital: collaborator
• Shandong Cancer Hospital and Institute: collaborator

Study Sites (2)

Shandong Cancer Hospital and Institute

Jinan, Shandong, 25117, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

Location

Study Officials

• Jin Li, M.D.

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 14, 2022
• Study Start: April 11, 2022
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)