Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate

Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumours.

 

Phase II

Primary Endpoints:

• 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

therapeutic portion.

– 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.