This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

Logo

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

Sponsored by Anbogen Therapeutics, Inc.

About this trial

Last updated 2 years ago

Study ID

ABT101-102

Status

Recruiting

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18+ Years
All Sexes

Trial Timing

Started 4 years ago

What is this trial 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)

What are the participation requirements?

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