IMC-001 for metastatic or locally advanced solid tumors with high tumor mutational burden
Official title: PHASE 2 STUDY OF IMC-001 IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED TMB-H SOLID TUMOR
Run by ImmuneOncia Therapeutics Inc. · NCT06365840 · Data updated 2026-11-12
This trial will test whether IMC-001 helps adults with metastatic or locally advanced solid tumors that have high tumor mutational burden (TMB-H).
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | ImmuneOncia Therapeutics Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 4 sites (Goyang and 3 other locations) |
| Status | Recruiting |
| Started | January 13, 2025 |
| Main results expected | June 30, 2027 |
| Study ends | August 2029 |
| Registry record updated | April 17, 2026 |
| Trial ID | NCT06365840 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically or cytologically confirmed metastatic or locally advanced solid tumors that are TMB-H (≥16 mut/Mb), have at least one measurable lesion, ECOG 0–1, available tumor tissue for central review, and who meet treatment washout requirements.
✕Probably not a fit
Patients whose tumors are not TMB-H, who have ECOG performance status >1, cannot provide tumor tissue, or cannot meet washout or organ function requirements are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 2 interventional trial of IMC-001 in adults with metastatic or locally advanced solid tumors that are TMB-H. Eligible tumors must have TMB ≥16 mut/Mb as measured by the TruSight Oncology 500 or Oncomine Comprehensive Assay Plus and at least one measurable lesion per RECIST 1.1. Participants must have ECOG 0–1, meet required washout periods from prior therapies, and provide tumor tissue for central pathology review. The trial is being conducted at major cancer centers in South Korea and will track tumor response and safety after IMC-001 treatment.
Why it matters
Potential benefit: If successful, IMC-001 could offer a new treatment option that shrinks tumors or slows disease progression for patients with TMB-H advanced solid tumors.
How similar studies have gone: Other TMB-directed immunotherapy approaches have shown clinical benefit in some tumor types (for example, pembrolizumab was approved for TMB-H tumors), but IMC-001 itself is still experimental and undergoing Phase 2 testing.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Documented TMB-H:≥ 16 mut/Mb, determined by the TruSightTM Oncology 500 NGS panel or OncomineTM Comprehensive Assay Plus
2. Histologically or cytologically proven metastatic or locally advanced solid tumors.The participant must have at least one measurable tumor lesion per RECIST 1.1.
3. Investigator has confirmation that participant's tumor tissue is available to be submitted to a central pathology laboratory.
4. Adult age(as defined by respective country)
5. The nature of the study and voluntarily sign an ICF
6. ECOG 0 or1
7. 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.
8. 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.
9. Adequate hematologic function, hepatic function, and renal function
10. 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.
11. 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.
12. Predicted life expectancy of at least 16 weeks.
Exclusion Criteria:
1. Previously treated with an anti-PD-L1 or anti-PD-1 antibody
2. Known presence of symptomatic CNS metastases
3. Any active autoimmune disease or a documented history of autoimmune disease
4. Apparent active and known viral infection with HIV, hepatitis B virus or hepatitis C virus
5. Pregnant or lactating
Where it's running
-
National Cancer Center
Goyang, South Korea Recruiting -
Seoul National University Bundang Hospital
Seongnam, South Korea Recruiting -
Samsung Medical Center
Seoul, South Korea Recruiting -
Severance Hospital
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Jeeyun Lee — Samsung Medical Center, Republic of Korea
- Study coordinator: Sungyoung Lee
- Email: sylee@immuneoncia.com
- Phone: +82 2 6283 5096
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.