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Advanced Solid TumorPhase 1NCT05278546

A Study of ILB2109 in Patients With Advanced Solid Malignancies

A Phase 1 study testing ILB2109 in people with Advanced Solid Tumor, run by Innolake Biopharm at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
ILB2109
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
2 sitesChina
Study dates
11 Apr 2022to Feb 2025
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
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  • 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;

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Shandong Cancer Hospital and Institute

    Jinan, Shandong, 25117

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200123

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
ILB2109

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ILB2109Drug

    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.

Study groups in NCT05278546
Study groupRoleWhat they receive
Treatment ArmExperimentalThere are nine escalating dose cohorts.
Receives: Drug: ILB2109

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Incidence of DLTs

    The incidence rate of Dose Limiting Toxicities (DLTs)

    Measured: At the end of Cycle 0 and 1 (Cycle 0 is 3 days, Cycle 1 is 21 days)

  2. MTD

    Determining the maximum tolerated dose (MTD) for subsequent studies

    Measured: 30 Months

  3. RD

    Determining the Recommended Dose (RD) for subsequent studies

    Measured: 30 Months

Secondary outcomes (10)

  1. 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;

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

  2. 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.

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

  3. Progression Free Survival (PFS)

    The time from randomization of patients to the onset of disease progression.

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

  4. Overall Survival (OS)

    The time from randomization to death for any reason

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

  5. 1-Year OS

    The probability of a survival time of 1 year after treatment for this disease

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

  6. Time To Response (TTR)

    Time from the start of treatment to the first objective tumor response

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

  7. Duration Of Response (DOR)

    The time from response to progression/death

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

  8. 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.

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

  9. Maximum Plasma Concentration (Cmax)

    Characterize the single-dose and multiple-dose plasma concentration of ILB2109

    Measured: 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)

  10. Area Under the plasma drug concentration-time Curve (AUC)

    Characterize the single-dose and multiple-dose plasma concentration of ILB2109

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2022
  2. Study start11 Apr 2022
  3. Primary completionDec 2024 (estimated)
  4. Study completionFeb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05278546
Sponsor's protocol ID
CILB2109A101
Status last verified
Nov 2024
First submitted
23 Feb 2022
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ILB2109 in people with Advanced Solid Tumor, run by Innolake Biopharm at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Incidence of DLTs (time frame: At the end of Cycle 0 and 1 (Cycle 0 is 3 days, Cycle 1 is 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05278546.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.

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