Evaluating ABT-101 for patients with advanced solid tumors and non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1b/2 open-label, multicenter study aimed at determining the recommended phase 2 dosage of ABT-101 in patients with advanced solid tumors and assessing its antitumor activity in those with HER2 mutations in non-small cell lung cancer (NSCLC). The study consists of two parts: the first part focuses on dose escalation to identify the optimal dosage while monitoring for dose-limiting toxicities, and the second part evaluates the safety and efficacy of the determined dosage in NSCLC patients. Participants will undergo a screening period, treatment period, and safety follow-up until disease progression or withdrawal criteria are met.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Study coordinator: Anbogen
• Email: clinicaltrial@anbogen.com
• Phone: +886-2-2742-1839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.