Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
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)
| Condition(s) | Advanced Solid Tumor, Non Small Cell Lung Cancer, HER2 Mutations |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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) |
| Who can participate | 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 * R |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Anbogen Therapeutics, Inc. |
| Locations | Taichung, Taiwan; Tainan, Taiwan; Taipei, Taiwan; Taipei, Taiwan; Taoyuan, Taiwan |
| Start date | 2022-09-27 |
| NCT ID | NCT05532696 |
| Official listing | https://clinicaltrials.gov/study/NCT05532696 |