Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate
Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumours.
• Overall response rate (ORR) at 12 weeks by RECIST 1.1 of different targeted agents
in molecularly selected small subject populations.
Subjects must have metastatic or unresectable malignant tumor, histologically or
cytological confirmed and progressing to current therapy. Tumors must be refractory
to standard therapy or for which standard therapy does not exist, or subjects may be
unable to receive standard therapy.
This study has two parts: part A, which includes the common procedures for tumor
molecular profiling and treatment recommendation, and part B, which corresponds to the
– Part A includes a molecular profiling program for subjects with advanced solid tumors
(iPROFILER) and a molecular tumor board to select the most appropriate treatment
based on the molecular alterations found in the iPROFILER.
– Part B includes iBASKET, a modular investigator initiated basket study for subjects with
selected molecular alterations. Each module is focused on a certain molecular pathway or
on certain molecular alterations that may confer sensitivity to the study drug or study
drug combination evaluated in that module/arm.