UOMi Cancer Center | Barcelona, Spain
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Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-655, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors.
Phase 1 will evaluate the overall safety and tolerability of NVL-655 and will determine the RP2D and, if applicable, the MTD of NVL-655 in patients with advanced ALK+ solid tumors.
Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-655 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-655 in patients with advanced ALK-positive NSCLC and other solid tumors.
Full description
In Phase 2, study patients will be enrolled into 6 distinct cohorts:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age ≥18 years, Phase 2 Cohort 2f only: Age ≥12 years and weighing >40 kg.
Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation.
Phase 2
Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1 Phase 2: Must have measurable disease according to RECIST 1.1
Adequate organ function and bone marrow reserve
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
470 participants in 7 patient groups
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Central trial contact
Tina Kehrig
Data sourced from clinicaltrials.gov
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