A Phase 1b/2, open-label, multicenter study to determine the recommended phase 2 (RP2D) of ABT-101in solid tumor and to explore antitumor activities of ABT-101 in patients with HER 2 mutated non-small cell lung cancer (NSCLC)
This study will be conducted in two parts: Part 1: Dose- Escalation, Phase 1b, is designed to determine the RP2D. Patients with solid tumor will be enrolled into a dose finding study scheme with the assessment of dose-limiting toxicities (DLTs). DLT assessment will be conducted during treatment cycle 1 Part 2: Dose- Expansion, Phase 2, will evaluate the safety and efficacy of ABT-101 at the dosage and dosing regime determined in Phase 1b. Phase 2 will enroll NSCLC patients with HER2 mutations Study participation for all patients includes screening period, treatment period and safety/ follow-up period. Patient will received study treatment until progressive disease or any other discontinuation or withdrawal criterion is met
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Patients will receive ABT-101 by oral administration on a 28-day cycle
Taichung Veterans General Hospital
Taichung, Taiwan
RECRUITINGNational Cheng Kung University Hospital
Tainan, Taiwan
RECRUITINGNational Taiwan University Hospital
Taipei, Taiwan
Determine the recommended Phase 2 Dose (RP2D) of ABT-101 in Part 1
Determine the maximum tolerated dose (MTD) and RP2D of ABT-101 based on Dose Limiting Toxicities
Time frame: 18 months
Determine antitumor activity based on Objective Response Rate (ORR) in Part 2 in patients with NSCLC with targeted mutation
Patients response according to RECIST 1.1
Time frame: 36 months
Maximum plasma concentration (Cmax) ABT-101
Plasma concentration of ABT-101
Time frame: 48 months
Area under the plasma concentration time curve (AUC) of ABT-101
Measure of AUC
Time frame: 48 months
Duration of response (DOR)
DOR is defined as the length of time between first response and the date of objectively documented progression of disease or death
Time frame: 48 months
Progression- free survival (PFS)
Measure of the time from study entry to disease progression or death due to any cause
Time frame: 36 months
Overall survival (OS)
Measure of overall survival
Time frame: 36 months
Objective response rate (ORR) in Part 1
Objective response rate as determined by RECIST 1.1
Time frame: 12 months
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Taipei Medical Univresity Hospital
Taipei, Taiwan
RECRUITINGChang Gung Memorial Hospital, Linkou
Taoyuan District, Taiwan
RECRUITINGDisease control rate (DCR)
DCR is defined as the percentage of patients who have achieved a CR, PR, or SD.
Time frame: 36 months