Clinical Trials in Taiwan / NCT05532696
Recruiting Phase 1/2

Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients

NCT05532696 · tracked via the Priya Life Science Taiwan tracker
Sponsor
Anbogen Therapeutics, Inc
Phase
Phase 1/2
Started
2022-09-27
Last updated
2024-06-24

Condition(s) studied

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)

Trial sites (5)

FacilityCityRegionStatus
Taichung Veterans General Hospital Taichung Taiwan Recruiting
National Cheng Kung University Hospital Tainan Taiwan Recruiting
National Taiwan University Hospital Taipei Taiwan Recruiting
Taipei Medical Univresity Hospital Taipei Taiwan Recruiting
Chang Gung Memorial Hospital, Linkou Taoyuan Taiwan Recruiting

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Other trials for the same condition

Official registry record

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.

View NCT05532696 on ClinicalTrials.gov ↗ ← All trials in Taiwan