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

June 21, 2024 updated by: Anbogen Therapeutics, Inc.

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 36 months
Patients response according to RECIST 1.1
36 months
Determine the recommended Phase 2 Dose (RP2D) of ABT-101 in Part 1
Time Frame: 18 months
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)
Time Frame: 48 months
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)
Time Frame: 36 months
Measure of the time from study entry to disease progression or death due to any cause
36 months
Overall survival (OS)
Time Frame: 36 months
Measure of overall survival
36 months
Objective response rate (ORR) in Part 1
Time Frame: 12 months
Objective response rate as determined by RECIST 1.1
12 months
Disease control rate (DCR)
Time Frame: 36 months
DCR is defined as the percentage of patients who have achieved a CR, PR, or SD.
36 months
Maximum plasma concentration (Cmax) ABT-101
Time Frame: 48 months
Plasma concentration of ABT-101
48 months
Area under the plasma concentration time curve (AUC) of ABT-101
Time Frame: 48 months
Measure of AUC
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anbogen Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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