Evaluating ABT-101 for patients with advanced solid tumors and non-small cell lung cancer
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
This study is testing a new drug called ABT-101 to see if it can help people with advanced solid tumors, especially those with certain mutations in non-small cell lung cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 61 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Anbogen Therapeutics, Inc. Industry-sponsored |
| Locations | 5 sites (Taichung and 4 other locations) |
| Trial ID | NCT05532696 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 and older with advanced solid tumors or HER2 mutated NSCLC who meet specific health criteria.
Not a fit: Patients with active CNS metastases, prior treatment with EGFR or HER2 TKIs, or those with serious infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with HER2 mutated NSCLC and advanced solid tumors.
How similar studies have performed: Other studies have shown promise with similar approaches targeting HER2 mutations, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Taichung and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.