NCT05532696

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: Anbogen Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This study will be conducted in two parts: Part 1: Dose- Escalation, Phase 1b, is designed to determine the RP2D. Patients with solid tumor will be enrolled into a dose finding study scheme with the assessment of dose-limiting toxicities (DLTs). DLT assessment will be conducted during treatment cycle 1 Part 2: Dose- Expansion, Phase 2, will evaluate the safety and efficacy of ABT-101 at the dosage and dosing regime determined in Phase 1b. Phase 2 will enroll NSCLC patients with HER2 mutations Study participation for all patients includes screening period, treatment period and safety/ follow-up period. Patient will received study treatment until progressive disease or any other discontinuation or withdrawal criterion is met

Conditions

• Advanced Solid Tumor
• Non Small Cell Lung Cancer
• HER2 Mutations

Interventions

Type	Name	Description
DRUG	ABT-101	Patients will receive ABT-101 by oral administration on a 28-day cycle

Timeline

• Start date: 2022-09-27
• Primary completion: 2026-11-01
• Completion: 2027-05-01
• First posted: 2022-09-08
• Last updated: 2024-06-24

Locations

5 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study