New drug IMC-001 targets Hard-to-Treat cancers in small trial
NCT ID NCT06365840
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests the drug IMC-001 in 30 adults with advanced solid tumors that have a high number of genetic mutations (TMB-H). Participants receive the drug by IV every two weeks. The main goal is to see if the drug shrinks tumors. Researchers will also monitor side effects and how long the benefit lasts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IMC-001 (a drug given by IV infusion every 2 weeks)
- What this could lead to
- If successful, this could point toward a new treatment option for people with advanced solid tumors that have a high number of genetic mutations.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply to everyone. The drug may not shrink tumors or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Cancer Center
RECRUITINGGoyang, South Korea
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Samsung Medical Center
RECRUITINGSeoul, South Korea
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Seoul National University Bundang Hospital
RECRUITINGSeongnam, South Korea
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Severance Hospital
RECRUITINGSeoul, South Korea