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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllAnbogen Therapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male or female aged โ‰ฅ 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 5ร— the half-life prior to the first dose. * Not recovered from prior- treatment toxicities to Grade โ‰ค1 * 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 โ‰ฅ 470 ms * Significant gastrointestinal disorder(s) that could interfere with absorption of ABT101 * Known to have a history of alcoholism or drug abuse
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What it tests

  • ABT-101
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Where

5 sites
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, Taiwan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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