SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03114319

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

An Open-label, Multi-center, Phase I, Dose Finding Study of Oral TNO155 in Adult Patients With Advanced Solid Tumors

The purpose of this first in human (FIH) trial is to characterize the safety and tolerability of the SHP2 inhibitor TNO155 and identify a recommended dose for future studies in adult patients with advanced solid tumors in selected indications.

NCT03114319 Advanced EGFRmutant NonSmallSellLungCancer (NSCLC),KRAS G12C NSCLC,CRC,Esophageal SquamousCellCancer (SCC),Head/Neck SCC,RAS/RAF Wild-type Other Solid Tumor

1 Interventions

Name: TNO155

Description: TNO155 for oral administration

Type: Drug

TNO155


Primary Outcomes

Description: All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments

Measure: Number of participants with adverse events

Time: up to 3 years; at least once per treatment cycle

Description: Incidence and nature of dose limiting toxicities (DLTs) in the dose escalation part. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle (either 21 days or 28 days, depending on the cohort's treatment schedule) with TNO155

Measure: Number of participants with dose limiting toxicities

Time: up to 28-day cycle

Secondary Outcomes

Description: Area under the plasma concentration time curve of TNO155

Measure: Area under the curve

Time: 30 months

Description: To evaluate the preliminary anti-tumor activity of TNO155, e.g., overall response rate per RECIST 1.1

Measure: Overall response rate

Time: From start of treatment for 34 months

Description: On treatment versus baseline comparison of pharmacodynamic markers e.g., pERK (Phosphorylated form of Extracellular signal-regulated kinase) on newly obtained tumor samples by IHC

Measure: pERK

Time: At screening and between Cycle 1 and Cycle 3 on treatment for 30 months

Description: highest observed plasma concentration of TNO155

Measure: Cmax

Time: 30 months

Description: Time of highest observed plasma concentration of TNO155

Measure: tmax

Time: 30 months

Description: terminal elimination half-life of TNO155

Measure: apparent terminal elimination half-life

Time: 30 months

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 G12C

(Exceptions are KRAS G12C CRC and KRAS G12C NSCLC) 2. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO. 3. Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures. --- G12C ---

(Exceptions are KRAS G12C CRC and KRAS G12C NSCLC) 2. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO. 3. Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures. --- G12C --- --- G12C ---

Advanced EGFRmutant NonSmallSellLungCancer (NSCLC),KRAS G12C NSCLC,CRC,Esophageal SquamousCellCancer (SCC),Head/Neck SCC,RAS/RAF Wild-type Other Solid Tumor This study has been designed as a Phase I, open-label, dose finding study with a dose escalation part and a dose expansion part in adult patients with selected advanced solid tumors. --- G12C ---



HPO Nodes