SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03466268

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase I Trial to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of SCC244 in Subjects With Advanced Solid Tumors

This study evaluates the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of SCC244 in patients with advanced solid tumors with c-Met Alterations.

NCT03466268 Advanced Solid Tumor

1 Interventions

Name: Glumetinib for tablet

Description: Either at 100mgSD、100mgQD、200mgSD、200mgQD、400mgSD、400mgQD、300mgBID、400mgBID

Type: Drug

Dose escalation study of Glumetinib


Primary Outcomes

Description: To evaluate the DLT in patients with advanced solid tumor

Measure: DLT(Dose limit toxity)

Time: 35 days

Description: To evaluate the MTD in patients with advanced solid tumor

Measure: MTD(Max tolerance does)

Time: 35 days

Description: To evaluate the BED in patients with advanced solid tumor

Measure: BED(Biological effective dose)

Time: 35 days

Description: To evaluate the ORR in patients with advanced solid tumor in Ib

Measure: ORR(Objective response rate)

Time: 8 weeks

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 T790M

No EGFR T790M mutation for subjects with c-Met gene amplification or c-Met protein overexpression; KRAS/ALK/ROS1 WT or unknown mutation/rearrangement status for subjects with c-Met exon 14 skipping mutation. --- T790M ---

4. Presence of EGFR T790M mutation in NSCLC subjects pretreated with an EGFR-TKI; Known KRAS/ALK/ROS1 mutation/rearrangement in NSCLC subjects with c-Met exon 14 skipping mutation. --- T790M ---



HPO Nodes