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

Phase 1

Recruiting

• Conditions: HER2 Mutations; Advanced Solid Tumor; Non Small Cell Lung Cancer
• Interventions: Drug: ABT-101

• Registration Number: NCT05532696
• Lead Sponsor: Anbogen Therapeutics, Inc.

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

Study Timeline

• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-08
• Study Start: 2022-09-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24
• Primary Completion: 2026-11
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABT-101	ABT-101	Part 1- dose-escalation: ABT-101 in patients with advanced cancer disease Part 2- dose expansion: ABT-101 in patients with NSCLC with confirmed HER2 mutations

Primary Outcome Measures

Name	Time	Method
Determine the recommended Phase 2 Dose (RP2D) of ABT-101 in Part 1	18 months	Determine the maximum tolerated dose (MTD) and RP2D of ABT-101 based on Dose Limiting Toxicities
Determine antitumor activity based on Objective Response Rate (ORR) in Part 2 in patients with NSCLC with targeted mutation	36 months	Patients response according to RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax) ABT-101	48 months	Plasma concentration of ABT-101
Overall survival (OS)	36 months	Measure of overall survival
Duration of response (DOR)	48 months	DOR is defined as the length of time between first response and the date of objectively documented progression of disease or death
Progression- free survival (PFS)	36 months	Measure of the time from study entry to disease progression or death due to any cause
Area under the plasma concentration time curve (AUC) of ABT-101	48 months	Measure of AUC
Objective response rate (ORR) in Part 1	12 months	Objective response rate as determined by RECIST 1.1
Disease control rate (DCR)	36 months	DCR is defined as the percentage of patients who have achieved a CR, PR, or SD.

Trial Locations

Locations (5)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

Taipei Medical Univresity Hospital; 🇨🇳 Taipei, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Chang Gung Memorial Hospital, Linkou; 🇨🇳 Taoyuan, Taiwan