RecruitingPhase 1Phase 2NCT05532696
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
Sponsor
Anbogen Therapeutics, Inc.
Enrollment
61 participants
Start Date
Sep 27, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
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)
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria11
- 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
Interventions
DRUGABT-101
Patients will receive ABT-101 by oral administration on a 28-day cycle
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05532696
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