SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03189030

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 1 Safety and Tolerability Study of Personalized Live, Attenuated, Double-Deleted Listeria Monocytogenes (pLADD) Immunotherapy in Adults With Metastatic Colorectal Cancer

This study will evaluate the safety and tolerability of a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD) treatment in adults with metastatic colorectal cancer.

NCT03189030 Colorectal Neoplasms
MeSH: Colorectal Neoplasms
HPO: Neoplasm of the large intestine

1 Interventions

Name: pLADD

Description: via IV infusion

Type: Biological

Treatment arm


Primary Outcomes

Description: Number of patients with treatment-related adverse events as assessed by CTCAE v 4.0

Measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Time: Through study completion, an average of 12 months

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 V600E

Inclusion Criteria: - metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS) - able to provide adequate tumor tissue from at least 1 accessible tumor site - completed or have developed intolerance to a course of oxaliplatin- or irinotecan-based frontline therapy at Screening - on maintenance standard-of-care chemotherapies or on treatment holiday - Eastern Cooperative Oncology Group (ECOG) 0 or 1 - adequate organ function - progression of disease at the time of Enrollment Exclusion Criteria: - BRAF V600E mutation - known allergy to both penicillin and sulfa drugs - implanted devices that cannot be easily removed - immunodeficiency, immune compromised state or receiving immunosuppressive therapy Inclusion Criteria: - metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS) - able to provide adequate tumor tissue from at least 1 accessible tumor site - completed or have developed intolerance to a course of oxaliplatin- or irinotecan-based frontline therapy at Screening - on maintenance standard-of-care chemotherapies or on treatment holiday - Eastern Cooperative Oncology Group (ECOG) 0 or 1 - adequate organ function - progression of disease at the time of Enrollment Exclusion Criteria: - BRAF V600E mutation - known allergy to both penicillin and sulfa drugs - implanted devices that cannot be easily removed - immunodeficiency, immune compromised state or receiving immunosuppressive therapy Colorectal Neoplasms Colorectal Neoplasms This single arm study is designed to evaluate the safety and tolerability of a personalized treatment in adults with metastatic colorectal cancer by first analyzing the expression of tumor-associated antigens and then treating the patients with a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD)-based immunotherapy. --- V600E ---

Inclusion Criteria: - metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS) - able to provide adequate tumor tissue from at least 1 accessible tumor site - completed or have developed intolerance to a course of oxaliplatin- or irinotecan-based frontline therapy at Screening - on maintenance standard-of-care chemotherapies or on treatment holiday - Eastern Cooperative Oncology Group (ECOG) 0 or 1 - adequate organ function - progression of disease at the time of Enrollment Exclusion Criteria: - BRAF V600E mutation - known allergy to both penicillin and sulfa drugs - implanted devices that cannot be easily removed - immunodeficiency, immune compromised state or receiving immunosuppressive therapy Inclusion Criteria: - metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS) - able to provide adequate tumor tissue from at least 1 accessible tumor site - completed or have developed intolerance to a course of oxaliplatin- or irinotecan-based frontline therapy at Screening - on maintenance standard-of-care chemotherapies or on treatment holiday - Eastern Cooperative Oncology Group (ECOG) 0 or 1 - adequate organ function - progression of disease at the time of Enrollment Exclusion Criteria: - BRAF V600E mutation - known allergy to both penicillin and sulfa drugs - implanted devices that cannot be easily removed - immunodeficiency, immune compromised state or receiving immunosuppressive therapy Colorectal Neoplasms Colorectal Neoplasms This single arm study is designed to evaluate the safety and tolerability of a personalized treatment in adults with metastatic colorectal cancer by first analyzing the expression of tumor-associated antigens and then treating the patients with a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD)-based immunotherapy. --- V600E --- --- V600E ---



HPO Nodes


HPO:
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