Advanced Solid TumorNon Small Cell Lung CancerHER2 Mutations
Investigational drug(s) / intervention(s)
ABT-101
ABT-101: Patients will receive ABT-101 by oral administration on a 28-day cycle
Study 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)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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