NCT05532696RecruitingPhase 1/2
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
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
Source: ClinicalTrials.gov · Last updated 24 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 61 (estimated)
- First submitted
- 30 Aug 2022
- Start date
- 27 Sept 2022
- Primary completion date
- Nov 2026
- Lead sponsor
- Anbogen Therapeutics, Inc.
- Diseases
- Lung cancer
- NCT number
- NCT05532696
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 61
- From 27 Sept 2022 to the primary completion date, Nov 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Serious acute or chronic infections
- Significant gastrointestinal disorder(s) that could interfere with absorption of ABT101
- Known to have a history of alcoholism or drug abuse
Lab values
- For patients in Part 2 only: Previously treated with EGFR or HER2 TKIs.
Other
- Known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
- History or presence of clinically relevant cardiovascular abnormalities. QTcF ≥ 470 ms
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| Taipei Medical Univresity Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Chang Gung Memorial Hospital, Linkou Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.