RecruitingPhase 2

A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor

South Korea30 participantsStarted 2025-01-13

Plain-language 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.

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. 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
✓. 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.

Exclusion criteria

✕. 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

What they're measuring

ORR

Timeframe: 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).

Trial details

NCT IDNCT06365840

SponsorImmuneOncia Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

SUNGYOUNG LEE

+82 2 6283 5096 sylee@immuneoncia.com

View on ClinicalTrials.gov More TMB-H trials