Molecular profiling guided therapy for advanced solid tumors

KOrean Precision Medicine Networking Group Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II

This study is testing if personalized cancer treatments based on patients' genetic information can help people with advanced solid tumors who haven't responded to standard therapies.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Seoul National University Bundang Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 32 sites (Bucheon-si and 31 other locations)
• Trial ID: NCT05525858 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of molecular profiling guided therapy based on genomic alterations in patients with advanced solid tumors who have progressed on standard treatments or have no standard options available. It involves a multi-center approach where patients' genomic data is analyzed to identify actionable targets, and treatment recommendations are made by a molecular tumor board (MTB). Patients may receive investigational therapies or alternative treatments based on their genomic profiles. The study seeks to enhance personalized treatment strategies for patients with complex cancer cases.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 and older with histologically confirmed locally advanced or metastatic solid tumors that have shown disease progression on standard first-line treatments.

Not a fit: Patients with solid tumors that have standard treatment options available or those without sufficient genomic information may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with advanced solid tumors.

How similar studies have performed: Other studies utilizing molecular profiling for targeted therapies have shown promising results, indicating that this approach is gaining traction in cancer treatment.

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

Where this trial is running

Bucheon-si and 31 other locations

• Soonchunhyang University Hospital Bucheon — Bucheon-si, South Korea (Recruiting)
• Chungbuk National University Hospital — Chungju, South Korea (Recruiting)
• Keimyung University Dongsan Hospital — Daegu, South Korea (Recruiting)
• Kyungpook National University Chilgok Hospital — Daegu, South Korea (Recruiting)
• Yeungnam University Medical Center — Daegu, South Korea (Recruiting)
• Chungnam National University Hospital — Daejeon, South Korea (Recruiting)
• National Cancer Center — Goyang, South Korea (Recruiting)
• Chonnam National University Hwasun Hospital — Hwasun, South Korea (Recruiting)
• Gachon University Gil Medical Center — Incheon, South Korea (Recruiting)
• The Catholic University of Korea, Incheon St. Mary's Hospital — Incheon, South Korea (Recruiting)
• Jeonbuk National University Hospital — Jeonju, South Korea (Recruiting)
• Gyeongsang National University Hospital — Jinju, South Korea (Recruiting)
• Dong-A University Hospital — Pusan, South Korea (Recruiting)
• Cha University Bundang Medical Center — Seongnam, South Korea (Recruiting)
• Seoul National University Bundang Hospital — Seongnam, South Korea (Recruiting)
• Asan Medical Center — Seoul, South Korea (Recruiting)
• Chung-ang University Hospital — Seoul, South Korea (Recruiting)
• Ewha womans university Mokdong Hospital — Seoul, South Korea (Recruiting)
• Gangbuk Samsung Hospital — Seoul, South Korea (Recruiting)
• Hanyang University Hospital — Seoul, South Korea (Terminated)
• Korea University Anam Hospital — Seoul, South Korea (Recruiting)
• Korea University Guro Hospital — Seoul, South Korea (Recruiting)
• Samsung Medical Center — Seoul, South Korea (Recruiting)
• Seoul National University Hospital — Seoul, South Korea (Recruiting)
• The Catholic University of Korea, Seoul ST. Mary's Hospital — Seoul, South Korea (Recruiting)
• The Catholic University of Korea, Yeouido St. Mary's Hospital — Seoul, South Korea (Recruiting)
• Yonsei Cancer Hospital — Seoul, South Korea (Recruiting)
• Ajou University Hospital — Suwon, South Korea (Recruiting)
• The Catholic University of Korea, ST. Vincent's Hospital — Suwon, South Korea (Recruiting)
• Ulsan University Hospital — Ulsan, South Korea (Recruiting)
• Wonju Severance Christian Hospital — Wŏnju, South Korea (Recruiting)
• Pusan National University Yangsan Hospital — Yangsan, South Korea (Recruiting)

Study contacts

• Study coordinator: Jeehyun Kim

Conditions Solid Tumor; Advanced Solid Tumor; Metastatic Cancer