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

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new drug called ABT-101 in two groups: people with any advanced solid tumor (Phase 1b dose-finding), and people with non-small cell lung cancer (NSCLC) that has a specific HER2 mutation (Phase 2). **You may be eligible if...** - You are 20 or older (or the adult age in your country) - You have an advanced solid tumor (for Phase 1) or NSCLC with a confirmed HER2 mutation (for Phase 2) - You have measurable disease (for Phase 2) - You are in good functional health (ECOG 0–1 for Phase 1; 0–2 for Phase 2) - Your organ function is adequate **You may NOT be eligible if...** - You have active or untreated brain metastases - For Phase 2: you have previously been treated with EGFR or HER2-targeted therapies - You have serious active infections or received a live vaccine recently - You received prior cancer therapy within 28 days - You have a significant heart condition (QTcF ≥470 ms) - You have a gastrointestinal disorder that would prevent the drug from being absorbed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABT-101

Patients will receive ABT-101 by oral administration on a 28-day cycle


Locations(5)

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical Univresity Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan, Taiwan

View Full Details on ClinicalTrials.gov

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NCT05532696


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