NCT05532696

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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
12mo left

Started Sep 2022

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Sep 2022May 2027

First Submitted

Initial submission to the registry

August 30, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

September 27, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

4.1 years

First QC Date

August 30, 2022

Last Update Submit

June 21, 2024

Conditions

Advanced Solid TumorNon Small Cell Lung CancerHER2 Mutations

Keywords

ABT-101NSCLCHER2 Mutations

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (7)

  • Maximum plasma concentration (Cmax) ABT-101

    48 months

  • Area under the plasma concentration time curve (AUC) of ABT-101

    48 months

  • Duration of response (DOR)

    48 months

  • Progression- free survival (PFS)

    36 months

  • Overall survival (OS)

    36 months

  • +2 more secondary outcomes

Study Arms (1)

ABT-101

EXPERIMENTAL

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

Interventions

ABT-101DRUG

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

Also known as: DBPR112
ABT-101

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

Taipei Medical Univresity Hospital

Taipei, 11031, Taiwan

RECRUITING

Chang Gung Memorial Hospital, Linkou

Taoyuan District, 33305, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Anbogen

CONTACT

+886-2-2742-1839clinicaltrial@anbogen.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 8, 2022

Study Start

September 27, 2022

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

June 24, 2024

Record last verified: 2024-06

Locations

TW(5)