SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT04000529

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies

This study is a Phase Ib, multi-center, open-label study of TNO155 in combination with spartalizumab or ribociclib with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors. These two treatment arms will enroll subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary antitumor activity. The study treatment will be administered until the subject experiences unacceptable toxicity, progressive disease, and/or has treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.

NCT04000529 Non-small Cell Lung Carcinoma Head and Neck Squamous Cell Carcinoma Esophageal SCC Gastrointestinal Stromal Tumors Colorectal Cancer
MeSH: Carcinoma Colorectal Neoplasms Carcinoma, Squamous Cell Lung Neoplasms Squamous Cell Carcinoma of Head and Neck Gastrointestinal Stromal Tumors Carcinoma, Non-Small-Cell Lung Esophageal Squamous Cell Carcinoma
HPO: Carcinoma Gastrointestinal stroma tumor Neoplasm of the large intestine Neoplasm of the lung Non-small cell lung carcinoma Squamous cell carcinoma

3 Interventions

Name: TNO155

Description: Capsule

Type: Drug

TNO155 in combination with spartalizumab TNO155 in combination with ribociclib

Name: Spartalizumab

Description: Concentrate for solution for infusion

Type: Drug

TNO155 in combination with spartalizumab

Name: Ribociclib

Description: Capsule and tablet

Type: Drug

TNO155 in combination with ribociclib


Primary Outcomes

Description: Incidence of dose limiting toxicities (DLTs) during the first cycle of combination treatment during the dose escalation part

Measure: DLT incidence

Time: 1 year

Description: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as per CTCAE v5.0, by treatment

Measure: AE and SAE incidence

Time: 3 years

Description: Dose tolerability

Measure: Dose interruptions, reductions and dose intensity, by treatment

Time: 3 years

Secondary Outcomes

Description: Cmax for TNO155, spartalizumab, and ribociclib

Measure: Pharmacokinetics (PK): Cmax

Time: 3 years

Description: Tmax for TNO155, spartalizumab, and ribociclib

Measure: Pharmacokinetics (PK): Tmax

Time: 3 years

Description: AUClast for TNO155, spartalizumab, and ribociclib

Measure: Pharmacokinetics (PK): AUClast

Time: 3 years

Description: AUCtau for TNO155, spartalizumab, and ribociclib

Measure: Pharmacokinetics (PK): AUCtau

Time: 3 years

Description: Overall response rate (ORR) per RECIST v1.1, by treatment

Measure: Efficacy measurements per RECIST v1.1: ORR

Time: 3 years

Description: Disease control rate (DCR) per RECIST v1.1, by treatment

Measure: Efficacy measurements per RECIST v1.1: DCR

Time: 3 years

Description: Progression-free survival (PFS) per RECIST v1.1, by treatment

Measure: Efficacy measurements per RECIST v1.1: PFS

Time: 3 years

Description: Duration of response (DOR) per RECIST v1.1, by treatment

Measure: Efficacy measurements per RECIST v1.1: DOR

Time: 3 years

Description: Overall response rate (ORR) per iRECIST for TNO155 in combination with spartalizumab

Measure: Efficacy measurements per iRECIST: ORR

Time: 3 years

Description: Disease control rate (DCR) per iRECIST for TNO155 in combination with spartalizumab

Measure: Efficacy measurements per iRECIST: DCR

Time: 3 years

Description: Progression-free survival (PFS) per iRECIST for TNO155 in combination with spartalizumab

Measure: Efficacy measurements per iRECIST: PFS

Time: 3 years

Description: Duration of response (DOR) per iRECIST for TNO155 in combination with spartalizumab

Measure: Efficacy measurements per iRECIST: DOR

Time: 3 years

Description: Overall survival (OS) by treatment

Measure: Overall Survival

Time: 3 years

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 G12C

For TNO155 plus spartalizumab combination: i. Advanced EGFR WT, ALK WT, KRAS G12C NSCLC after progression on or intolerance to platinum-containing combination chemotherapy and after progression on anti-PD-1 or anti-PD-L1 therapy. --- G12C ---



HPO Nodes


HPO:
Carcinoma
Genes 11
PTEN CDKN1B APC MLH1 MSH2 FGFR3 KIT DKC1 RSPO1 STK11 NLRP1
Gastrointestinal stroma tumor
Genes 17
CD19 MS4A1 TNFRSF13C CR2 PDGFRA TNFSF12 KIT TNFRSF13B PRKCD CD81 SDHA NFKB1 SDHB NFKB2 SDHC SDHD ICOS
Neoplasm of the large intestine
Genes 71
FOXE1 PMS1 CDKN2A KRAS MST1 TGFBR2 STK11 MSH6 TCF4 BMPR1A PMS2 KLLN MLH3 DLC1 NRAS BRCA1 BRCA2 PDGFRA DOCK8 PIK3CA GPR35 POLD1 NTHL1 POLE SRC BUB1 SH3KBP1 BUB1B CHEK2 APC MLH1 PRKAR1A FLCN COL14A1 AKT1 RPS19 RPS20 HABP2 MSH2 FGFR3 MSH3 KEAP1 GREM1 MINPP1 SEMA4A CTNNB1 DCC BUB3 PTEN MDM2 CEP57 ENG AAGAB TRIP13 KIT EPCAM DICER1 RNF43 PALLD EP300 PALB2 SEC23B MUTYH SDHA TP53 SDHB SDHC SDHD AXIN2 SMAD4 FAN1
Neoplasm of the lung
Genes 43
WT1 KRAS SLC22A18 STK11 IRF1 AKT1 C11ORF95 PRKN PPP2R1B ERBB2 TRPV3 TSC1 POU6F2 TSC2 EWSR1 RELA KEAP1 REST DIS3L2 SFTPA2 GPC3 MBTPS2 LMNA PTEN BRAF BRCA2 EGFR RB1 TRIP13 PDGFRB TERT SFTPC PIK3CA TRIM28 DICER1 MAP3K8 HPGD SLCO2A1 H19 TP53 NOTCH3 BAP1 WRN
Non-small cell lung carcinoma
Genes 2
TP53 BAP1
Squamous cell carcinoma
Genes 62
BLM TYR CDKN2A NUTM1 TGFBR2 KRT5 COL7A1 GTF2E2 GJB2 ERCC2 KRT14 ERCC3 CIB1 ERCC4 ERCC5 WWOX LMNA SASH1 RNF6 TINF2 ING1 SLC17A9 DOCK8 LZTS1 PSENEN FDPS NTHL1 CTSC GJB6 BRD4 POLH RECQL4 RNF113A TMC6 FERMT1 MC1R WRN TMC8 LAMA3 MPLKIP GTF2H5 WNT10A DKC1 LAMB3 NLRP1 LAMC2 SLC45A2 OCA2 XPC MMP1 TNFRSF10B DCC WRAP53 TERC TERT RSPO1 DDB2 SLX4 STAT1 MVD IL7 MVK