Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients

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

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

Conditions5

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