Any offical word if AP113 has reached RP2D)? I didn't have time to read each slide last night.
Detailed Description:
This is the first assessment of AP26113 in patients. The trial will be conducted in 2 parts: an initial dose escalation phase in 30 to 50 patients with advanced malignancies (all histologies other than leukemia), resistant to available therapies or for whom no standard or available curative treatments exist, followed by an expansion phase in 4 histologically and molecularly defined cohorts of patients (20 patients per cohort, approximately 80 patients altogether). The objectives of the dose escalation phase are to determine the safety, tolerability, pharmacokinetic profile, and recommended phase 2 dose (RP2D) of orally administered AP26113. The objectives of the expansion phase are to describe the preliminary anti-tumor activity (overall response rate) of AP26113 in patients with non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) gene rearrangement or mutated epidermal growth factor receptor (EGFR), and in patients with any cancers with abnormalities in ALK or other targets against which AP26113 is active, and to continue to assess safety and tolerability.
