Advanced Solid TumorPhase 1NCT05508100
Dose Confirmation and Dose Expansion Phase 1 Study of IO-108 and IO-108 + Anti-PD-1 in Solid Tumors
A Phase 1 study testing IO-108, IO-108 + pembrolizumab and IO-108 + tislelizumab in people with Advanced Solid Tumor, run by Immune-Onc Therapeutics at 14 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- IO-108, IO-108 + pembrolizumab and IO-108 + tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 14 sitesChina
- Study dates
- 9 Sep 2022to 30 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18, and < 75.
- 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.
- Patients have at least 1 measurable disease per RECIST v1.1 as assessed by local clinical site.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Patients must have adequate hematologic function, hepatic function and renal function.
Who cannot join
- Patients who previously received a monoclonal antibody therapy targeting LILRB2/ILT4 (including IO-108).
- 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.
- 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.
- History of radiation pneumonitis, non-infectious pneumonitis or interstitial lung disease expect for radioactive pulmonary fibrosis not requiring corticosteroid treatment.
- Symptomatic central nervous system (CNS) metastases. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Hunan Cancer Hospital
Changsha, Hunan, 410031
The First Affiliated Hospital of Fujian Medical University
Fujian, Fuzhou
1st affiliated Hospital of Hainan Medical University
Haikou, Hainan
Sir RUN RUN SHAW HOSPITAL
Hangzhou, Zhejiang
Harbin Cancer Hospital
Harbin, Heilongjiang
Shandong Cancer Hospital
Jinan, Shandong, 250117
Lin Yi Cancer Hospital
Linyi, Shandong
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330052
Shanghai Dong Fang Hospital
Shanghai, Shanghai Municipality, 200120
Liaoning Cancer Hospital
Shenyang, Liaoning
4th Hospitla of Hebei Medical University
Shijiazhuang, Hebei
Tongji Hospital
Wuhan, Hubei
1st Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi
Henan Cancer Hospital
Zhengzhou, Henan
About this study
Official title: 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- IO-108, IO-108 + pembrolizumab, IO-108 + tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IO-108Biological
IO-108, intravenously, on Day 1 of each 21-day cycle.
IO-108 + pembrolizumabBiological
Also called IO-108 + Keytruda®
IO-108, intravenously, on Day 1 of each 21-day cycle. Pembrolizumab will be administered intravenously on Day 1 of each 21-day cycle.
IO-108 + tislelizumabBiological
IO-108, intravenously, on Day 1 of each 21-day cycle. Tislelizumab will be administered intravenously on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Part A: IO-108 monotherapy dose confirmation | Experimental | Patients with advanced or metastatic solid tumors will be enrolled and treated with IO-108, intravenously, every 21 days. Receives: Biological: IO-108 |
| Part B: IO-108 + anti-PD-1 dose confirmation. | Experimental | 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. Receives: Biological: IO-108 + pembrolizumab; Biological: IO-108 + tislelizumab |
| Part C: Dose expansion | Experimental | Patients with advanced or metastatic solid tumors who meet the specific criteria will be enrolled into one of the cohorts. Receives: Biological: IO-108 + pembrolizumab; Biological: IO-108 + tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) in patients treated with IO-108
AE severity graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
Measured: 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
AE severity graded by NCI CTCAE, Version 5.0
Measured: through study completion, an average of 2 years
Preliminary anti-tumor activity of IO-108 in combination with pembrolizumab or tislelizumab
ORR is defined as the percentage of patients who have a complete response (CR) or a partial response (PR) per RECIST v1.1
Measured: through study completion, an average of 2 years
Secondary outcomes (5)
Maximum plasma concentration (Cmax) of IO-108
Characterize the Cmax of IO-108 by successive sampling of blood at pre-specified time points
Measured: through study completion, an average of 2 years
Steady state concentration of IO-108
Characterize steady state concentration of IO-108 by successive sampling of blood at pre-specified time points
Measured: through study completion, an average of 2 years
Anti-drug antibodies (ADA) of IO-108
Determine the incidence and titer of ADAs against IO-108
Measured: through study completion, an average of 2 years
Preliminary anti-tumor activity
Disease Control Rate, defined as the percentage of patients with CR, PR, or stable disease.
Measured: through study completion, an average of 2 years
Preliminary anti-tumor activity
Progression-free Survival, defined as the time interval from the first dose date to the occurrence of disease progression or death of any cause
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start9 Sep 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immune-Onc Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508100
- Sponsor's protocol ID
- IO-108-CL-002
- Status last verified
- Jul 2023
- First submitted
- 12 Aug 2022
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05508100
- Acronym / sponsor ID
- IO-108-CL-002
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Immune-Onc TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: IO-108 monotherapy dose confirmation | Experimental | Biological: IO-108Patients with advanced or metastatic solid tumors will be enrolled and treated with IO-108, intravenously, every 21 days. |
| Part B: IO-108 + anti-PD-1 dose confirmation. | Experimental | Biological: IO-108 + pembrolizumab, Biological: IO-108 + tislelizumabPatients 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. |
| Part C: Dose expansion | Experimental | Biological: IO-108 + pembrolizumab, Biological: IO-108 + tislelizumabPatients with advanced or metastatic solid tumors who meet the specific criteria will be enrolled into one of the cohorts. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18, and < 75.
- 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.
- Patients have at least 1 measurable disease per RECIST v1.1 as assessed by local clinical site.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Key exclusion criteria (5 listed)
- Patients who previously received a monoclonal antibody therapy targeting LILRB2/ILT4 (including IO-108).
- 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.
- 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.
- History of radiation pneumonitis, non-infectious pneumonitis or interstitial lung disease expect for radioactive pulmonary fibrosis not requiring corticosteroid treatment.
- Symptomatic central nervous system (CNS) metastases. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IO-108IO-108, intravenously, on Day 1 of each 21-day cycle. | Biological | Part A: IO-108 monotherapy dose confirmation |
| IO-108 + pembrolizumabAlso: IO-108 + Keytruda®IO-108, intravenously, on Day 1 of each 21-day cycle. Pembrolizumab will be administered intravenously on Day 1 of each 21-day cycle. | Biological | Part B: IO-108 + anti-PD-1 dose confirmation., Part C: Dose expansion |
| IO-108 + tislelizumabIO-108, intravenously, on Day 1 of each 21-day cycle. Tislelizumab will be administered intravenously on Day 1 of each 21-day cycle. | Biological | Part B: IO-108 + anti-PD-1 dose confirmation., Part C: Dose expansion |
Primary outcome
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
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
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
5 secondary outcomes
Maximum plasma concentration (Cmax) of IO-108
Time frame: through study completion, an average of 2 years
Steady state concentration of IO-108
Time frame: 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
Preliminary anti-tumor activity
Time frame: through study completion, an average of 2 years
Preliminary anti-tumor activity
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IO-108, IO-108 + pembrolizumab and IO-108 + tislelizumab in people with Advanced Solid Tumor, run by Immune-Onc Therapeutics at 14 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 5 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: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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?
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 24 May 2024.