Dose Confirmation and Dose Expansion Phase 1 Study of IO-108 and IO-108 + Anti-PD-1 in Solid Tumors

May 23, 2024 updated by: Immune-Onc Therapeutics

A Phase 1, Open-Label, Multicenter Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IO-108 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody in Adult Patients With Advanced or Metastatic Solid Tumors

This is a Phase 1 study to evaluate the safety, tolerability, PK, and preliminary efficacy of IO-108 monotherapy and in combination with anti-PD-1 monoclonal antibody pembrolizumab or tislelizumab in adult patients with advanced solid tumors. The study will be conducted in 3 parts, including Part A IO-108 monotherapy dose confirmation; Part B IO-108 + anti-PD-1 dose confirmation, and Part C dose expansion.

Study Overview

Status

Status

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

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.

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 (Actual)

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.
38

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 Contact Backup

Study Locations

  • China
    • Fuzhou
      • Fujian, Fuzhou, China
        • The First Affiliated Hospital of Fujian Medical University
    • Hainan
      • Haikou, Hainan, China
        • 1st affiliated Hospital of Hainan Medical University
    • Hebei
      • Shijia Zhuang, Hebei, China
        • 4th Hospitla of Hebei Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Harbin Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital
    • Hunan
      • Changsha, Hunan, China, 410031
        • Hunan Cancer Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330052
        • The First Affiliated Hospital of Nanchang University
    • Liaoning
      • Shenyang, Liaoning, China
        • Liaoning Cancer Hospital
    • Shandong
      • Jinan, Shandong, China, 250117
        • Shandong Cancer Hospital
      • Linyi, Shandong, China
        • Lin Yi Cancer Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200120
        • Shanghai Dong Fang Hospital
    • Shanxi
      • Xian, Shanxi, China
        • 1st Affiliated Hospital of Xi'an Jiaotong University
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Sir Run Run Shaw Hospital

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18, and < 75.

  2. Part A and Part B Cohort 1: Patients must have histologically or cytologically confirmed advanced or metastatic solid tumor and have failed, or have been intolerant for standard systemic therapy, or for whom no treatment known to confer clinical benefit exists.

    Part B Cohort 2 and Part C: Patient with advanced or metastatic solid tumor who meet the specific criteria.

  3. Patients have at least 1 measurable disease per RECIST v1.1 as assessed by local clinical site.
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
  5. Patients must have adequate hematologic function, hepatic function and renal function.

Exclusion Criteria:

  1. Patients who previously received a monoclonal antibody therapy targeting LILRB2/ILT4 (including IO-108).
  2. Patients who received chemotherapy, radiotherapy, biologic therapy, targeted therapy, immunotherapy, or other investigational anti-cancer therapy < 4 weeks prior to their first day of study drug administration.
  3. Requires systemic corticosteroids at a dose of >10 mg daily of prednisone or the dose equivalent to other systemic corticosteroid, or other immunosuppressive agents ≤ 14 days prior to the first dose.
  4. History of radiation pneumonitis, non-infectious pneumonitis or interstitial lung disease expect for radioactive pulmonary fibrosis not requiring corticosteroid treatment.
  5. Symptomatic central nervous system (CNS) metastases. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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: Non-Randomized
  • Interventional Model: Parallel 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: Part A: IO-108 monotherapy dose confirmation
Patients with advanced or metastatic solid tumors will be enrolled and treated with IO-108, intravenously, every 21 days.
Biological: IO-108
IO-108, intravenously, on Day 1 of each 21-day cycle.
Experimental: Part B: IO-108 + anti-PD-1 dose confirmation.
Patients will receive IO-108 in combination with with a fixed dose of pembrolizumab, intravenously, every 21 days; Patients will receive IO-108 in combination with with a fixed dose of tislelizumab, intravenously, every 21 days.
Biological: IO-108 + pembrolizumab
IO-108, intravenously, on Day 1 of each 21-day cycle. Pembrolizumab will be administered intravenously on Day 1 of each 21-day cycle.
Other Names:
  • IO-108 + Keytruda®
Biological: IO-108 + tislelizumab
IO-108, intravenously, on Day 1 of each 21-day cycle. Tislelizumab will be administered intravenously on Day 1 of each 21-day cycle.
Experimental: Part C: Dose expansion
Patients with advanced or metastatic solid tumors who meet the specific criteria will be enrolled into one of the cohorts.
Biological: IO-108 + pembrolizumab
IO-108, intravenously, on Day 1 of each 21-day cycle. Pembrolizumab will be administered intravenously on Day 1 of each 21-day cycle.
Other Names:
  • IO-108 + Keytruda®
Biological: IO-108 + tislelizumab
IO-108, intravenously, on Day 1 of each 21-day cycle. Tislelizumab will be administered intravenously on Day 1 of each 21-day cycle.

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
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) in patients treated with IO-108
Time Frame: through study completion, an average of 2 years
AE severity graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
through study completion, an average of 2 years
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) in patients treated with IO-108 in combination with pembrolizumab or tislelizumab
Time Frame: through study completion, an average of 2 years
AE severity graded by NCI CTCAE, Version 5.0
through study completion, an average of 2 years
Preliminary anti-tumor activity of IO-108 in combination with pembrolizumab or tislelizumab
Time Frame: through study completion, an average of 2 years
ORR is defined as the percentage of patients who have a complete response (CR) or a partial response (PR) per RECIST v1.1
through study completion, an average of 2 years

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
Maximum plasma concentration (Cmax) of IO-108
Time Frame: through study completion, an average of 2 years
Characterize the Cmax of IO-108 by successive sampling of blood at pre-specified time points
through study completion, an average of 2 years
Steady state concentration of IO-108
Time Frame: through study completion, an average of 2 years
Characterize steady state concentration of IO-108 by successive sampling of blood at pre-specified time points
through study completion, an average of 2 years
Preliminary anti-tumor activity
Time Frame: through study completion, an average of 2 years
Progression-free Survival, defined as the time interval from the first dose date to the occurrence of disease progression or death of any cause
through study completion, an average of 2 years
Anti-drug antibodies (ADA) of IO-108
Time Frame: through study completion, an average of 2 years
Determine the incidence and titer of ADAs against IO-108
through study completion, an average of 2 years
Preliminary anti-tumor activity
Time Frame: through study completion, an average of 2 years
Disease Control Rate, defined as the percentage of patients with CR, PR, or stable disease.
through study completion, an average of 2 years

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.
Immune-Onc Therapeutics

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.
September 9, 2022

Primary Completion (Actual)

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.
April 30, 2024

Study Completion (Actual)

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.
April 30, 2024

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).
August 12, 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.
August 18, 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.
August 19, 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 24, 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 23, 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.
July 1, 2023

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.
  • IO-108-CL-002

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.

No

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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