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A Phase Ib/II, Open-Label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ABT-101 in Patients With Advanced Solid Tumors and HER2 Exon 20 Insertions Mutated Non- Small Cell Lung Cancer
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)
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical Univresity Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, Taiwan
Start Date
September 27, 2022
Primary Completion Date
November 1, 2026
Completion Date
May 1, 2027
Last Updated
June 24, 2024
61
ESTIMATED participants
ABT-101
DRUG
Lead Sponsor
Anbogen Therapeutics, Inc.
NCT06898450
NCT06066138
Data Source & Attribution
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