A Study of ILB2109 in Patients With Advanced Solid Malignancies

May 19, 2024 updated by: Innolake Biopharm

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 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
Time Frame: 30 Months
Determining the maximum tolerated dose (MTD) for subsequent studies
30 Months
RD
Time Frame: 30 Months
Determining the Recommended Dose (RD) for subsequent studies
30 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety Outcomes
Time Frame: From Informed Consent to 28 days after the last dose, expected follow-up period 6 months
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 Frame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
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)
Time Frame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
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)
Time Frame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
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)
Time Frame: 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)
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)
Time Frame: 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)
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)
Time Frame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
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)
Time Frame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
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)
Time Frame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
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
Time Frame: Tumor assessment every 6 weeks (+/- 7 days) until disease progression, expected follow-up period 6 months
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma Concentration of Downstream Signaling Protein
Time Frame: 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)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Innolake Biopharm

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shandong Cancer Hospital and Institute
Shanghai East Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jin Li, M.D., Shanghai East Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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