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

Primary Purpose

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

Status

Recruiting

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

ABT-101

About this trial

This is an interventional treatment trial for Advanced Solid Tumor focused on measuring ABT-101, NSCLC, HER2 Mutations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female aged ≥ 20 years of age 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 patient in Part 2 only: Patients has measurable disease per RECIST 1.1 criteria
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Appropriate candidate for experimental therapy
Adequate organ function

Exclusion Criteria:

Known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
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 >450 ms in males or >470 ms in females
Significant gastrointestinal disorder(s) that could interfere with absorption of ABT101
Known to have a history of alcoholism or drug abuse

Sites / Locations

National Cheng Kung University HospitalRecruiting
National Taiwan University HospitalRecruiting
Chang Gung Memorial Hospital, Linkou

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABT-101

Arm Description

Part 1- dose-escalation: ABT101 in patient with advanced cancer disease Part 2- dose expansion: ABT101 in patients with NSCLC with confirmed HER2 mutations

Outcomes

Primary Outcome Measures

Determine the recommended Phase 2 Dose (RP2D) of ABT101 in Part 1

Determine the maximum tolerated dose (MTD) and RP2D of ABT101 based on Dose Limiting Toxicities

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

Secondary Outcome Measures

Maximum plasma concentration (Cmax) ABT-101

Plasma concentration of ABT101

Area under the plasma concentration time curve (AUC) of ABT101

Measure of AUC

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

Progression- free survival (PFS)

Measure of the time from study entry to disease progression or death due to any cause

Overall survival (OS)

Measure of overall survival

Objective response rate (ORR) in Part 1

Objective response rate as determined by RECIST 1.1

Number of patients with treatment-emergent adverse events as assessed by CTCAE v5.0

Evaluate safety and tolerability of futibatinib in combination with binimetinib based on treatment-emergent adverse events per CTCAE v5.0(including serious adverse events),clinical laboratory parameters, ECGs, and vital signs

Disease control rate (DCR)

DCR is defined as the percentage of patients who have achieved a CR, PR, or SD.

Full Information

NCT ID

NCT05532696

First Posted

August 30, 2022

Last Updated

March 9, 2023

Sponsor

Anbogen Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05532696

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 Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 27, 2022 (Actual)

Primary Completion Date

November 2026 (Anticipated)

Study Completion Date

May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Anbogen Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. 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 the preliminary antitumor activities of ABT101 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

ABT-101, NSCLC, HER2 Mutations

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

121 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ABT-101

Arm Type

Experimental

Arm Description

Part 1- dose-escalation: ABT101 in patient with advanced cancer disease Part 2- dose expansion: ABT101 in patients with NSCLC with confirmed HER2 mutations

Intervention Type

Drug

Intervention Name(s)

ABT-101

Other Intervention Name(s)

DBPR112

Intervention Description

Patients will receive ABT-101 by oral administration on a 28 days cycle

Primary Outcome Measure Information:

Title

Determine the recommended Phase 2 Dose (RP2D) of ABT101 in Part 1

Description

Determine the maximum tolerated dose (MTD) and RP2D of ABT101 based on Dose Limiting Toxicities

Time Frame

12 months

Title

Determine antitumor activity based on Objective Response Rate (ORR) in Part 2 in patients with NSCLC with targeted mutation

Description

Patients response according to RECIST 1.1

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Maximum plasma concentration (Cmax) ABT-101

Description

Plasma concentration of ABT101

Time Frame

48 months

Title

Area under the plasma concentration time curve (AUC) of ABT101

Description

Measure of AUC

Time Frame

48 months

Title

Duration of response (DOR)

Description

DOR is defined as the length of time between first response and the date of objectively documented progression of disease or death

Time Frame

48 months

Title

Progression- free survival (PFS)

Description

Measure of the time from study entry to disease progression or death due to any cause

Time Frame

36 months

Title

Overall survival (OS)

Description

Measure of overall survival

Time Frame

36 months

Title

Objective response rate (ORR) in Part 1

Description

Objective response rate as determined by RECIST 1.1

Time Frame

12 months

Title

Number of patients with treatment-emergent adverse events as assessed by CTCAE v5.0

Description

Time Frame

48 months

Title

Disease control rate (DCR)

Description

DCR is defined as the percentage of patients who have achieved a CR, PR, or SD.

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 patient 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anbogen

Phone

+886-2-2742-1839

clinicaltrial@anbogen.com

Facility Information:

Facility Name

National Cheng Kung University Hospital

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wu-Chou Su, M.D

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chia-Chi Lin, M.D

Facility Name

Chang Gung Memorial Hospital, Linkou

City

Taoyuan

ZIP/Postal Code

33305

Country

Taiwan

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wen-Cheng Chang, M.D

12. IPD Sharing Statement

Learn more about this trial

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

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