TMB-HPhase 2TMB-HNCT06365840
A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor
A Phase 2 study testing IMC-001 in people with TMB-H and Histologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors, run by ImmuneOncia Therapeutics Inc. at 4 sites in South Korea.
Trial summary
The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- TMB-H, Histologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors
- What is being tested?
- IMC-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 13 Jan 2025to Aug 2029
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented TMB-H:≥ 16 mut/Mb, determined by the TruSightTM Oncology 500 NGS panel or OncomineTM Comprehensive Assay Plus
- Histologically or cytologically proven metastatic or locally advanced solid tumors.The participant must have at least one measurable tumor lesion per RECIST 1.1.
- Investigator has confirmation that participant's tumor tissue is available to be submitted to a central pathology laboratory.
- Adult age(as defined by respective country)
- The nature of the study and voluntarily sign an ICF
- ECOG 0 or1
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- Prior systemic radiation therapy must be completed at least 4 weeks before the first dose of study drug. Prior focal radiotherapy must be completed at least 2 weeks before the first dose of study drug.
- At the time of the first dose of study drug at least 28 days since the last chemotherapy, immunotherapy, biological or investigational therapy, and have recovered from toxicities associated with such treatment to < Grade 2.
- Adequate hematologic function, hepatic function, and renal function
- Female participants must meet one of the following criteria:
- Postmenopausal (≥24 months, or ≥12 months with FSH > 40 IU/L),
- surgically incapable of bearing children (i.e., has had a hysterectomy or bilateral oophorectomy); or
- females of childbearing potential must agree to use a reliable form of contraceptive during the study treatment period and for at least 90 days following the last dose of study drug.
- Male participants must agree to use barrier contraception (i.e., condoms) for the duration of the study and for at least 90 days after the last dose of study drug.
- Predicted life expectancy of at least 16 weeks.
Who cannot join
- Previously treated with an anti-PD-L1 or anti-PD-1 antibody
- Known presence of symptomatic CNS metastases
- Any active autoimmune disease or a documented history of autoimmune disease
- Apparent active and known viral infection with HIV, hepatitis B virus or hepatitis C virus
- Pregnant or lactating
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 4 recruiting
- Recruiting
National Cancer Center
Goyang
Tak Yun, MD
- Recruiting
Seoul National University Bundang Hospital
Seongnam
Keun-Wook Lee, MD
- Recruiting
Samsung Medical Center
Seoul
Jeeyun Lee, MD
- Recruiting
Severance Hospital
Seoul
MinKyu Jung, MD
About this study
Official title: PHASE 2 STUDY OF IMC-001 IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED TMB-H SOLID TUMOR
The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients.
- Being tested
- IMC-001
- Keywords
- IMC-001,IMC-001-202,TMB-H
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMC-001Drug
All participants will receive the study drug, IMC-001, at 20 mg/kg Q2W via IV infusion over 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| IMC-001 | Experimental | Not described Receives: Drug: IMC-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Percentage of participants achieving a best overall response (BOR) of CR or PR by centralized independent review using RECIST 1.1 criteria.
Measured: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Secondary outcomes (12)
Evaluate additional efficacy variables of IMC-001
Terms, frequency, severity, and seriousness of adverse events (AEs) and relationship of AEs to IMC-001
Measured: through study completion, an average of 1 year
Evaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS)
Progression-Free Survival (PFS), (Unit of Measure: Months) Variables determined by the centralized independent assessment and Investigator's assessment based on RECIST Version 1.1
Measured: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Evaluate additional efficacy variables of IMC-001 : Duration of Response (DOR)
Duration of Response (DOR), (Unit of Measure: Months) Variables determined by the centralized independent assessment and Investigator's assessment based on RECIST Version 1.1
Measured: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Evaluate additional efficacy variables of IMC-001 : Time to Progression (TTP)
Time to Progression (TTP), (Unit of Measure: Months) Variables determined by the centralized independent assessment and Investigator's assessment based on RECIST Version 1.1
Measured: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Evaluate additional efficacy variables of IMC-001 : Disease Control Rate (DCR)
Disease Control Rate (DCR), (Unit of Measure: Percentage of participants) Variables determined by the centralized independent assessment and Investigator's assessment based on RECIST Version 1.1
Measured: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Evaluate additional efficacy variables of IMC-001 : Objective Response Rate (ORR)
Objective Response Rate (ORR), (Unit of Measure: Percentage of participants) Variables determined by the Investigator's assessment based on RECIST Version 1.1
Measured: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Evaluate additional efficacy variables of IMC-001 : Immune progression-free survival (iPFS)
Immune progression-free survival (iPFS), (Unit of Measure: Months) Variables determined by the centralized independent assessment and Investigator's assessment based on immune RECIST (iRECIST)
Measured: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Evaluate additional efficacy variables of IMC-001 : Immune duration of response (iDOR)
Immune duration of response (iDOR), (Unit of Measure: Months) Variables determined by the centralized independent assessment and Investigator's assessment based on immune RECIST (iRECIST)
Measured: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Evaluate additional efficacy variables of IMC-001 : Immune objective response rate (iORR)
Immune objective response rate (iORR), (Unit of Measure: Percentage of participants) Variables determined by the centralized independent assessment and Investigator's assessment based on immune RECIST (iRECIST)
Measured: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Survival Outcome : Overall Survival (OS)
Overall Survival (OS), (Unit of Measure: Months)
Measured: through study completion, an average of 1 year
Evaluate the pharmacokinetic (PK) profile of IMC-001
IMC-001 PK parameter: observed serum concentration immediately before dosing (Ctrough)
Measured: through study completion, an average of 1 year
Characterize the immunogenicity of IMC-001
Incidence of anti-drug antibody and neutralizing antibody (NAb) (including serum titers of anti-IMC-001 antibodies)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start13 Jan 2025
- Primary completion30 Jun 2027 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMB-HStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmuneOncia Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JEEYUN LEE, Principal investigator, Samsung Medical Center, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365840
- Sponsor's protocol ID
- IMC-001-202
- Acronym
- TMB-H
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2024
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE 2 STUDY OF IMC-001 IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED TMB-H SOLID TUMOR
- ClinicalTrials.gov ID
- NCT06365840
- Acronym / sponsor ID
- TMB-H / IMC-001-202
- Keywords
- IMC-001,IMC-001-202,TMB-H
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ImmuneOncia Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 15 Apr 2024 (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.
The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMC-001 | Experimental | Drug: IMC-001 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Documented TMB-H:≥ 16 mut/Mb, determined by the TruSightTM Oncology 500 NGS panel or OncomineTM Comprehensive Assay Plus
- Histologically or cytologically proven metastatic or locally advanced solid tumors.The participant must have at least one measurable tumor lesion per RECIST 1.1.
- Investigator has confirmation that participant's tumor tissue is available to be submitted to a central pathology laboratory.
- Adult age(as defined by respective country)
- The nature of the study and voluntarily sign an ICF
Key exclusion criteria (5 listed)
- Previously treated with an anti-PD-L1 or anti-PD-1 antibody
- Known presence of symptomatic CNS metastases
- Any active autoimmune disease or a documented history of autoimmune disease
- Apparent active and known viral infection with HIV, hepatitis B virus or hepatitis C virus
- Pregnant or lactating
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 |
|---|---|---|
| IMC-001All participants will receive the study drug, IMC-001, at 20 mg/kg Q2W via IV infusion over 60 minutes. | Drug | IMC-001 |
Primary outcome
ORR
Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Percentage of participants achieving a best overall response (BOR) of CR or PR by centralized independent review using RECIST 1.1 criteria.
12 secondary outcomes
Evaluate additional efficacy variables of IMC-001
Time frame: through study completion, an average of 1 year
Evaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS)
Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Evaluate additional efficacy variables of IMC-001 : Duration of Response (DOR)
Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Evaluate additional efficacy variables of IMC-001 : Time to Progression (TTP)
Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Evaluate additional efficacy variables of IMC-001 : Disease Control Rate (DCR)
Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Evaluate additional efficacy variables of IMC-001 : Objective Response Rate (ORR)
Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Evaluate additional efficacy variables of IMC-001 : Immune progression-free survival (iPFS)
Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Evaluate additional efficacy variables of IMC-001 : Immune duration of response (iDOR)
Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Evaluate additional efficacy variables of IMC-001 : Immune objective response rate (iORR)
Time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).
Survival Outcome : Overall Survival (OS)
Time frame: through study completion, an average of 1 year
Evaluate the pharmacokinetic (PK) profile of IMC-001
Time frame: through study completion, an average of 1 year
Characterize the immunogenicity of IMC-001
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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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.
JEEYUN LEE principal investigator
Samsung Medical Center, Republic of Korea
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMC-001 in people with TMB-H and Histologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors, run by ImmuneOncia Therapeutics Inc. at 4 sites in South Korea.
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 15 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact SUNGYOUNG LEE (+82 2 6283 5096, sylee@immuneoncia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Imaging every 6 weeks (±7 days) until PD or other anticancer therapy, during treatment (including EOT visit) and follow-up. EOT: 28 days (±3) after last dose. Max treatment: 2 years (52 cycles, each cycle is 14 days).). 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 17 Apr 2026.