Overview
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)
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
Eligibility
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