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RECRUITING
NCT05525858

KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II

Sponsor: Seoul National University Bundang Hospital

View on ClinicalTrials.gov

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)

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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2022-09-28

Completion Date

2027-03

Last Updated

2025-04-27

Healthy Volunteers

No

Interventions

DRUG

Alectinib

ALK fusion or mutations, Mutations or amplification in any of the following: RET

DRUG

Atezolizumab

MSI high status by any method Or Any mutation in any of these genes: MLH1 or MSH2 or MSH6 or PMS2 or EPCAM Or Any of the following mutations in POLE: R150X, P286R, P286H, S297F, Y298fs, F367S, V411, L424V, P436R, S459F, R665W, L698fs, R762W, R1519C, R1826W, D316H, D316G, R409W, L474P Or Any of the following mutations in POLD1: P112fs, A930fs, S478N Or Any mutation in the following: POLE not listed above, POLD1 not listed above, POLD2, POLD3, POLD4, POLQ or PRKDC Or Any loss of function mutations in BRCA1, BRCA2, ATM, MSH3, PMS1, MLH3, EXO1, RFC1, RFC2, RFC3, RFC4, RFC5, PCNA, RPA1, PRA2, PRA3, PRA4, or SSBP1 High tumor mutational burden decided by KOSMOS-II MTB (TMB ≥20/Mb in local NGS or if 10-20/Mb, confirmed by central NGS te sting)

DRUG

Erlotinib

EGFR Exon 19 deletions in the region E746\_E759; Any of the following EGFR mutations: E709A, E709G, E709K, E884K, G719A, G719C, G719S, L858R, L861Q, L833V, S768I

DRUG

Trastuzumab + Pertuzumab

ERBB2 amplification, or over-expression; or presence of any of the following ERBB2 mutations: G309A, G309E, S310F, S310Y, R678Q, I655V, D769H, D769Y, L755S, p.L75 5\_T759del, I767M, V777L, E321G, R896C; P780ins; delL755-T759 ERBB2 amplification or approved by the KOSMOS Molecular Tumor Board

DRUG

Trastuzumab emtansine

ERBB2 amplification, or over-expression; or presence of any of the following ERBB2 mutations: G309A, G309E, S310F, S310Y, R678Q, I655V, D769H, D769Y,L755S, p.L75 5\_T759del, I767M, V777L, E321G, R896C; P780ins; delL755-T759 ERBB2 oncogenic mutations; G152V, X215\_splice, D277Y, G292C, N302K, V308M, G309A, S310F, S310Y, S244C, L651V, V659E, G660D, R678Q, V697L, G727A, T733I, L755A, L755P, L755S, D769H, D769Y, A775\_G776insSVMA, A775\_G776insYVMA (i.e.,Y772\_A775dup,M774\_A775insAYVME 770delinsEAYVM), G776\_V777 \> AVCV, G776\_V777 \> AVGCV, G776\_V777 \> VCV, G776\_V777insVC, G776C, G776delinsLCT, G776L, G776dleinsVC, G776L777\_G778insC, V777L, V777M, G778\_Y779insGSP, P780\_Y781insGSP (i.e.,G778\_P780dup), L786V, N813D, R840W, V842I, T862A, R896G, E1021Q or approved by the KOSMOS Molecular Tumor Board

DRUG

Vemurafenib

BRAF\_V600E/D/K/R mutations

DRUG

Bevacizumab + Erlotinib

FH inactivating mutations or approved by the KOSMOS Molecular Tumor Board

DRUG

Entrectinib

ROS1 gene fusion using either a fluo rescence in situ hybridization (FISH) or next-generation sequencing (NGS) or approved by the KOSMOS Molecular Tumor Board

DRUG

Pralsetinib

RET fusion or mutations; CCDC6 RET, RET V804L, RET V804M, RET M918T, KIF5B-RET, RET C634W or approved by the KOSMOS Molecular Tumor Board

Locations (32)

Soonchunhyang University Hospital Bucheon

Bucheon-si, South Korea

Chungbuk National University Hospital

Chungju, South Korea

Keimyung University Dongsan Hospital

Daegu, South Korea

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Yeungnam University Medical Center

Daegu, South Korea

Chungnam National University Hospital

Daejeon, South Korea

National Cancer Center

Goyang, South Korea

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

The Catholic University of Korea, Incheon St. Mary's Hospital

Incheon, South Korea

Jeonbuk National University Hospital

Jeonju, South Korea

Gyeongsang National University Hospital

Jinju, South Korea

Dong-A University Hospital

Pusan, South Korea

Cha University Bundang Medical Center

Seongnam, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Asan Medical Center

Seoul, South Korea

Chung-ang University Hospital

Seoul, South Korea

Ewha womans university Mokdong Hospital

Seoul, South Korea

Gangbuk Samsung Hospital

Seoul, South Korea

Hanyang University Hospital

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, South Korea

The Catholic University of Korea, Yeouido St. Mary's Hospital

Seoul, South Korea

Yonsei Cancer Hospital

Seoul, South Korea

Ajou University Hospital

Suwon, South Korea

The Catholic University of Korea, ST. Vincent's Hospital

Suwon, South Korea

Ulsan University Hospital

Ulsan, South Korea

Wonju Severance Christian Hospital

Wŏnju, South Korea

Pusan National University Yangsan Hospital

Yangsan, South Korea