SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02675829

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 2 Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers

The purpose of this study is to find out what effects, a drug called ado-trastuzumab emtansine has on the patient and their cancer which is thought to be controlled by the abnormal HER2 gene.

NCT02675829 Solid Tumor Cancers Lung Cancer Bladder Cancer Urinary Tract Cancers
MeSH: Urinary Bladder Neoplasms Urologic Neoplasms
HPO: Bladder neoplasm Urinary tract neoplasm

1 Interventions

Name: ado-trastuzumab emtansine

Description: Ado-trastuzumab emtansine is administered intravenously at 3.6 mg/kg every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.

Type: Drug

Lung cancers, HER2 mutant Lung cancers, HER2 amplified Bladder and urinary tract cancers, HER2 amplified Other solid tumor cancers, HER2 amplified


Primary Outcomes

Description: As soon as evaluations for each tumor assessment are completed, the Investigator should assess the patient's overall response (target plus non- target lesions) based on criteria and overall response algorithms as defined in RECIST version 1.1. Scans must be assessable for all evaluations.

Measure: best overall response (ORR)

Time: 2 years

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There are 5 SNPs

SNPs


1 L755A

- Pathologically confirmed advanced solid tumor cancers - For Cohort 1, documented activating HER2 mutation in lung cancer by CLIA laboratory, specifically exon 20 insYVMA (Y772_A775dup), insGSP (G778_P780dup), insTGT (G776delinsVC), single base pair substitutions L755A, L755S, V777L, V659E, S310F, or another HER2 mutation approved by the Principal Investigator - For Cohorts 2, 3, 4, documented HER2 amplification identified through next generation sequencing by MSK-IMPACT or at another Clinical Laboratory Improvement Amendments (CLIA) laboratory, or documented HER2 amplification by in-situ hybridization (ISH) with HER2/CEP17 ratio ≥2.0 at a CLIA laboratory. --- L755A ---


2 L755S

- Pathologically confirmed advanced solid tumor cancers - For Cohort 1, documented activating HER2 mutation in lung cancer by CLIA laboratory, specifically exon 20 insYVMA (Y772_A775dup), insGSP (G778_P780dup), insTGT (G776delinsVC), single base pair substitutions L755A, L755S, V777L, V659E, S310F, or another HER2 mutation approved by the Principal Investigator - For Cohorts 2, 3, 4, documented HER2 amplification identified through next generation sequencing by MSK-IMPACT or at another Clinical Laboratory Improvement Amendments (CLIA) laboratory, or documented HER2 amplification by in-situ hybridization (ISH) with HER2/CEP17 ratio ≥2.0 at a CLIA laboratory. --- L755A --- --- L755S ---


3 S310F

- Pathologically confirmed advanced solid tumor cancers - For Cohort 1, documented activating HER2 mutation in lung cancer by CLIA laboratory, specifically exon 20 insYVMA (Y772_A775dup), insGSP (G778_P780dup), insTGT (G776delinsVC), single base pair substitutions L755A, L755S, V777L, V659E, S310F, or another HER2 mutation approved by the Principal Investigator - For Cohorts 2, 3, 4, documented HER2 amplification identified through next generation sequencing by MSK-IMPACT or at another Clinical Laboratory Improvement Amendments (CLIA) laboratory, or documented HER2 amplification by in-situ hybridization (ISH) with HER2/CEP17 ratio ≥2.0 at a CLIA laboratory. --- L755A --- --- L755S --- --- V777L --- --- V659E --- --- S310F ---


4 V659E

- Pathologically confirmed advanced solid tumor cancers - For Cohort 1, documented activating HER2 mutation in lung cancer by CLIA laboratory, specifically exon 20 insYVMA (Y772_A775dup), insGSP (G778_P780dup), insTGT (G776delinsVC), single base pair substitutions L755A, L755S, V777L, V659E, S310F, or another HER2 mutation approved by the Principal Investigator - For Cohorts 2, 3, 4, documented HER2 amplification identified through next generation sequencing by MSK-IMPACT or at another Clinical Laboratory Improvement Amendments (CLIA) laboratory, or documented HER2 amplification by in-situ hybridization (ISH) with HER2/CEP17 ratio ≥2.0 at a CLIA laboratory. --- L755A --- --- L755S --- --- V777L --- --- V659E ---


5 V777L

- Pathologically confirmed advanced solid tumor cancers - For Cohort 1, documented activating HER2 mutation in lung cancer by CLIA laboratory, specifically exon 20 insYVMA (Y772_A775dup), insGSP (G778_P780dup), insTGT (G776delinsVC), single base pair substitutions L755A, L755S, V777L, V659E, S310F, or another HER2 mutation approved by the Principal Investigator - For Cohorts 2, 3, 4, documented HER2 amplification identified through next generation sequencing by MSK-IMPACT or at another Clinical Laboratory Improvement Amendments (CLIA) laboratory, or documented HER2 amplification by in-situ hybridization (ISH) with HER2/CEP17 ratio ≥2.0 at a CLIA laboratory. --- L755A --- --- L755S --- --- V777L ---



HPO Nodes


HPO:
Bladder neoplasm
Genes 22
PTEN HRAS APC KRAS RB1 AAGAB FLCN PIK3CA COL14A1 RNF43 AKT1 EP300 NTHL1 FGFR3 AXIN2 ATP7A SRC CTNNB1 DLC1 BUB1B NRAS DCC
Urinary tract neoplasm
Genes 115
FOXE1 PMS1 CDKN1B CDKN1C VHL KRAS SOX9 H19-ICR HNF1A HNF1B POU6F2 PMS2 ATP7A DIS3L2 WWOX NRAS HDAC4 FN1 RB1 NTHL1 MAX KIF1B SRC FERMT1 WRN GATA4 WT1 APC NSD1 RPS20 SRY TSC1 TSC2 EXT2 MSH2 KEAP1 MINPP1 REST RET DCC MDH2 PTCH1 PTEN HNF4A AAGAB TMEM127 TRIP13 OGG1 DICER1 RNF43 ALX4 PALB2 PHF21A MAP3K1 TFE3 ZFPM2 AXIN2 BAP1 FAN1 NOD2 TBX18 TGFBR2 MET STK11 MSH6 BMPR1A KLLN MLH3 IGF2 DLC1 DMRT3 GPC3 LMNA BRCA2 SDHAF2 PIK3CA PRCC TRIM28 SETBP1 BUB1 SLC49A4 BUB1B VAMP7 NR0B1 GPC4 HRAS MLH1 FIBP KCNQ1 FLCN COL14A1 AKT1 HABP2 NR5A1 FGFR3 PAX6 CDC73 BMPER SEMA4A CTNNB1 FH BUB3 RNF139 CEP57 KCNQ1OT1 EPCAM TRIM37 EP300 SEC23B H19 SDHA TP53 SDHB SDHC SDHD