Spots Global Cancer Trial Database for Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients

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Trial Identification

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

Official Title: 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

Study ID: NCT05532696

Conditions

Advanced Solid Tumor

Non Small Cell Lung Cancer

HER2 Mutations

Interventions

ABT-101

Study Description

Brief 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