A phase 1/2, first-in-human, open-label study of the safety, tolerability, PK, and efficacy of the novel MET/CSF1R/SRC inhibitor TPX-0022 in adult subjects with advanced or metastatic NSCLC, Gastric Cancer, or solid tumors harboring genetic alterations in MET. (SHIELD-I)
Dose Escalation: To evaluate the overall safety profile of TPX-0022, single and multiple dose PK profiles and preliminary efficacy in adults subjects with advanced solid tumors harboring genetic alterations in MET. Dose Expansion: To evaluate the preliminary efficacy and overall safety profile of TPX-0022 at the RP2D in defined cohorts of adult subjects in NSCLC, Gastric Cancer and advanced solid tumors harboring genetic alterations in MET.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
95
Oral elzovantinib (TPX-0022) capsules
Local Institution - 2102
La Jolla, California, United States
Incidence of first cycle dose-limiting toxicities (DLTs) of elzovantinib
Evaluate the safety and tolerability of elzovantinib
Time frame: Within 28 days of the first elzovantinib dose for each patient
Define the Recommended Phase 2 Dose
Determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of elzovantinib
Time frame: Approximately 48 months
Adverse events (AEs)
Evaluate the overall safety profile of elzovantinib
Time frame: Approximately 48 months
Cmax (maximum plasma concentration) of elzovantinib
Evaluate the maximum plasma concentration of elzovantinib
Time frame: Up to 72 hours post-dose
AUC (area under plasma concentration time curve) of elzovantinib
Evaluate the AUC of elzovantinib
Time frame: Up to 72 hours post-dose
Cmax (maximum plasma concentration) of TPX-0022 under different food intake conditions
Determine the effect of food (specifically, a high-fat, high-calorie meal) on the single-dose PK (Cmax) of elzovantinib at the RP2D
Time frame: Up to 72 hours post-dose
AUC (area under plasma concentration time curve) of elzovantinib under different food intake conditions
Determine the effect of food (specifically, a high-fat, high-calorie meal) on the single-dose PK (AUC) of elzovantinib at the RP2D
Time frame: Up to 72 hours post-dose
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Detroit, Michigan, United States
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...and 14 more locations
Preliminary Objective Response Rate (ORR)
Determine the preliminary objective response rate (ORR) by Blinded Independent Central Review (BICR) of elzovantinib
Time frame: Approximately 48 months
Clinical benefit rate (CBR)
Determine the CBR of elzovantinib
Time frame: Approximately 48 months
Time to response (TTR)
Determine the TTR of elzovantinib
Time frame: Approximately 48 months
Duration of Response (DOR)
Determine the DOR of elzovantinib
Time frame: Approximately 48 months
Progression free survival (PFS)
Determine the PFS of elzovantinib
Time frame: Approximately 48 months
Intracranial tumor response
Determine the intracranial tumor response in subjects with measurable brain metastases, as determined by BICR
Time frame: Approximately 48 months
Overall survival (OS)
Determine efficacy and safety of elzovantinib
Time frame: Approximately 48 months