Actively Recruiting
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
Led by Anbogen Therapeutics, Inc. · Updated on 2024-06-24
61
Participants Needed
5
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 63 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 confirmed centrally (Part 2)
- For Part 2 patients: measurable disease according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for Part 1, and 0 to 2 for Part 2
- Suitable candidate for experimental therapy
- Adequate organ function
You will not qualify if you...
- Known active or untreated central nervous system (CNS) metastases or carcinomatous meningitis
- For Part 2 patients: prior treatment with EGFR or HER2 tyrosine kinase inhibitors (TKIs)
- Serious acute or chronic infections
- Recent live-virus vaccination
- Prior anticancer or investigational therapy within 28 days or 5 times the half-life before first dose
- Not recovered from previous treatment toxicities to Grade 61
- Major surgery within 28 days before study treatment
- Concurrent malignancy within 2 years prior to first dose
- History or presence of significant cardiovascular problems or QTcF 63 470 ms
- Significant gastrointestinal disorders that could affect ABT-101 absorption
- History of alcoholism or drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
2
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Actively Recruiting
3
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
4
Taipei Medical Univresity Hospital
Taipei, Taiwan, 11031
Actively Recruiting
5
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan, 33305
Actively Recruiting
Research Team
A
Anbogen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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