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

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05532696
• Other study ID #: ABT101-102
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 27, 2022
• Est. completion date: May 2027

Study information

• Verified date: January 2024
• Source: Anbogen Therapeutics, Inc.
• Contact: Anbogen
• Phone: +886-2-2742-1839
• Email: clinicaltrial[@]anbogen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: May 2027
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Anbogen Therapeutics, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

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