NCT05525858 KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
| NCT ID | NCT05525858 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seoul National University Bundang Hospital |
| Condition | Solid Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2022-09-28 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2022-09-28 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A national, prospective, multi-center, open-label, multi-cohort study comprised of a framework to screen patients for actionable targets and evaluation of molecular profiling guided therapy recommended by MTB based on genomic alterations using targeted and/or immunotherapies outside of the approved indications via local clinical practice (Tier 1 \& 2) and clinical trials (Tier 3)
Eligibility Criteria
Inclusion Criteria: * 19 years of age or older * Histologically proven locally advanced or metastatic solid tumors\*\*\* who showed disease progression on standard first line anti-cancer treatment and/or has no standard treatment option \*\*\* very rare diseases without standard treatment option which form solid mass, such as Erdheim Chester disease can be enrolled after KOSMOS MTB approval * A genomic test results must be available in a MFDS-accredited for laboratories offering service, or in part of clinical trial/study or other commercial labs approved and certified by regulatory bodies compatible with MFDS, such as CLIA. A genomic test can be conducted with tumor tissue as well as plasma circulating tumor DNA. 1. Results from genomic profiling tests performed after diagnosis with metastatic/advanced disease to registration are acceptable. NGS results performed within three years prior to registration are preferred. Those patients with NGS results from primary tumor or more than 3 years prior to enrollment can be registered and whether NGS data is acceptable will be subject to MTB decision. 2. NGS panels should be i. Tested in a lab that is accredited by one or more quality assurance program (e.g., Korean Institute of Genomic Testing Evaluation, The Korean Society of Pathologists, Korean Society for Laboratory Medicine, Korea Laboratory Accreditation Scheme, etc.) ii. Patients who have insufficient genomic information from their NGS results (e.g., lack of variant calling format file or uninterpretable reports) or who are candidates of immunotherapy will submit their tissue and/or blood, for central NGS testing and exploratory biomarker analysis. * Ability to understand and the willingness to sign a written informed consent document * Life expectancy of at least 12 weeks * Adequate recovery from most recent systemic or local treatment for cancer. Exclusion Criteria: * Patients receiving any anti-cancer treatment (local treatment, chemotherapy, immunotherapy, targeted therapy) within 2 weeks prior to the start of study treatment * Any clinical condition, according to the opinion of site physicians, which makes molecular profiling guided therapy not at the best interest of the participating patient. * Patients who have ongoing toxicities of ≥ CTCAE 2, other than peripheral neuropathy, related to previous anti-cancer treatment. Patients with ongoing peripheral neuropathy of ≥ CTCAE 3 will be excluded. Laboratory abnormalities ≥ CTCAE 2 considered as not clinically significant by the study physician will be allowed. * Pregnant or breastfeeding, or intending to become pregnant during the study
Contact & Investigator
JEEHYUN KIM
STUDY DIRECTOR
Seoul National University Bundang Hospital
Frequently Asked Questions
Who can join the NCT05525858 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05525858 currently recruiting?
Yes, NCT05525858 is actively recruiting participants. Contact the research team at kosmos2@kcsg.org for enrollment information.
Where is the NCT05525858 trial being conducted?
This trial is being conducted at Bucheon-si, South Korea, Chungju, South Korea, Daegu, South Korea, Daegu, South Korea and 11 additional locations.
Who is sponsoring the NCT05525858 clinical trial?
NCT05525858 is sponsored by Seoul National University Bundang Hospital. The principal investigator is JEEHYUN KIM at Seoul National University Bundang Hospital. The trial plans to enroll 1,000 participants.