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

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)

Study Overview

• Status: Recruiting
• Conditions: Non Small Cell Lung Cancer; Advanced Solid Tumor; HER2 Mutations
• Intervention / Treatment: Drug: ABT-101

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 Type: Interventional
• Enrollment (Estimated): 61
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Anbogen; Phone Number: +886-2-2742-1839; Email: clinicaltrial@anbogen.com

Study Locations

• Taiwan
  • Taichung, Taiwan, 40705
    • Recruiting
    • Taichung Veterans General Hospital
    • Contact: Tsung-Ying Yang, M.D
  • Tainan, Taiwan, 70403
    • Recruiting
    • National Cheng Kung University Hospital
    • Contact: Wu-Chou Su, M.D
  • Taipei, Taiwan, 10002
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chia-Chi Lin, M.D
  • Taipei, Taiwan, 11031
    • Recruiting
    • Taipei Medical Univresity Hospital
    • Contact: Chao-Hua Chiu, M.D
  • Taoyuan, Taiwan, 33305
    • Recruiting
    • Chang Gung Memorial Hospital, Linkou
    • Contact: Wen-Cheng Chang, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: ABT-101; Patients will receive ABT-101 by oral administration on a 28-day cycle; Other Names: DBPR112

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Anbogen Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 24, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: NSCLC; HER2 Mutations; ABT-101
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: ABT101-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No