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Trial Title:
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
NCT ID:
NCT05532696
Condition:
Advanced Solid Tumor
Non Small Cell Lung Cancer
HER2 Mutations
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
ABT-101
NSCLC
HER2 Mutations
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ABT-101
Description:
Patients will receive ABT-101 by oral administration on a 28-day cycle
Arm group label:
ABT-101
Other name:
DBPR112
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)
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
Criteria for 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 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Taichung Veterans General Hospital
Address:
City:
Taichung
Zip:
40705
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Tsung-Ying Yang, M.D
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Zip:
70403
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Wu-Chou Su, M.D
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chia-Chi Lin, M.D
Facility:
Name:
Taipei Medical Univresity Hospital
Address:
City:
Taipei
Zip:
11031
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Chao-Hua Chiu, M.D
Facility:
Name:
Chang Gung Memorial Hospital, Linkou
Address:
City:
Taoyuan
Zip:
33305
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Wen-Cheng Chang, M.D
Start date:
September 27, 2022
Completion date:
May 2027
Lead sponsor:
Agency:
Anbogen Therapeutics, Inc.
Agency class:
Industry
Source:
Anbogen Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05532696
