A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor

A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor

Gastrointestinal Stromal Tumor

Active, not recruiting

1/2

Start Date 08/19/2019

Age of Trial (yrs) 5.3

Gleevec-resistant

KIT/PDGFRA inhibitor + D842V inhibitor

Block KIT/PDGFRA

Specifically GIST and only GIST

CS3007-101

CStone Pharmaceuticals

Wendie YUAN +86 21 61097678 cstonera@cstonepharma.com

Oral

For phase I study, the subject must have histologically or cytologically confirmed unresectable or metastatic GIST that progressed after imatinib and at least one additional TKI treatment, or who cannot tolerate the standard treatment or have D842V mutation in the PDGFRα gene.

For phase II study:

i) Group 1: Chinese subjects with unresectable GIST harboring D842V mutation in PDGFRα gene.

ii) Group 2: Chinese subjects with unresectable GIST that has progressed following imatinib treatment or who don't tolerate imatinib (including in the adjuvant setting) and who have not received any other kinase inhibitor treatment. Patients must not have a known D842V mutation in PDGFRα gene.

iii) Group 3: Chinese subjects with unresectable GIST that doesn't harbor D824V mutation in PDGFRα gene and that has progressed despite treatment with imatinib and at least another tyrosine kinase inhibitor.
Subjects with at least one measurable lesion as defined per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to