Advanced Solid Tumor, HER2 Mutations, Non Small Cell Lung Cancer
Conditions
Keywords
ABT-101, NSCLC, HER2 Mutations
Brief summary
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)
Detailed description
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
Interventions
DRUGABT-101
Patients will receive ABT-101 by oral administration on a 28-day cycle
Sponsors
Anbogen Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged ≥ 20 years or adult age as per local regulations, at time of informed consent * Histologically or cytologically confirmed advanced solid tumor (Part 1) or NSCLC with HER2 mutations as determined by the central result (Part 2) * For patients in Part 2 only: Patients has measurable disease per RECIST 1.1 criteria * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Part 1), 0 to 2 (Part 2) * Appropriate candidate for experimental therapy * Adequate organ function
Exclusion criteria
* Known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis * For patients in Part 2 only: Previously treated with EGFR or HER2 TKIs. * Serious acute or chronic infections * Received a live-virus vaccination * Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose. * Not recovered from prior- treatment toxicities to Grade ≤1 * Major surgery within 28 days prior to the study treatment * Concurrent malignancy within 2 years prior to first dose * History or presence of clinically relevant cardiovascular abnormalities. QTcF ≥ 470 ms * Significant gastrointestinal disorder(s) that could interfere with absorption of ABT101 * Known to have a history of alcoholism or drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the recommended Phase 2 Dose (RP2D) of ABT-101 in Part 1 | 18 months | Determine the maximum tolerated dose (MTD) and RP2D of ABT-101 based on Dose Limiting Toxicities |
| Determine antitumor activity based on Objective Response Rate (ORR) in Part 2 in patients with NSCLC with targeted mutation | 36 months | Patients response according to RECIST 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration time curve (AUC) of ABT-101 | 48 months | Measure of AUC |
| Progression- free survival (PFS) | 36 months | Measure of the time from study entry to disease progression or death due to any cause |
| Maximum plasma concentration (Cmax) ABT-101 | 48 months | Plasma concentration of ABT-101 |
| Objective response rate (ORR) in Part 1 | 12 months | Objective response rate as determined by RECIST 1.1 |
| Disease control rate (DCR) | 36 months | DCR is defined as the percentage of patients who have achieved a CR, PR, or SD. |
| Overall survival (OS) | 36 months | Measure of overall survival |
| Duration of response (DOR) | 48 months | DOR is defined as the length of time between first response and the date of objectively documented progression of disease or death |
Countries
Taiwan
Contacts
Primary ContactAnbogen
Outcome results
None listed