Advanced Solid TumorPhase 1/2NCT05532696
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
A Phase 1/2 study testing ABT-101 in people with Advanced Solid Tumor and Non Small Cell Lung Cancer, run by Anbogen Therapeutics, Inc. at 5 sites in Taiwan.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Non Small Cell Lung Cancer, HER2 Mutations
- What is being tested?
- ABT-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 5 sitesTaiwan
- Study dates
- 27 Sep 2022to May 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Taiwan5 sites, 5 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
Tsung-Ying Yang, M.D
- Recruiting
National Cheng Kung University Hospital
Tainan, 70403
Wu-Chou Su, M.D
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Chia-Chi Lin, M.D
- Recruiting
Taipei Medical Univresity Hospital
Taipei, 11031
Chao-Hua Chiu, M.D
- Recruiting
Chang Gung Memorial Hospital, Linkou
Taoyuan, 33305
Wen-Cheng Chang, M.D
About this study
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
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)
Read the 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
- Being tested
- ABT-101
- Keywords
- ABT-101, NSCLC, HER2 Mutations
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-101Drug
Also called DBPR112
Patients will receive ABT-101 by oral administration on a 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: ABT-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 36 months
Secondary outcomes (7)
Maximum plasma concentration (Cmax) ABT-101
Plasma concentration of ABT-101
Measured: 48 months
Area under the plasma concentration time curve (AUC) of ABT-101
Measure of AUC
Measured: 48 months
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
Measured: 48 months
Progression- free survival (PFS)
Measure of the time from study entry to disease progression or death due to any cause
Measured: 36 months
Overall survival (OS)
Measure of overall survival
Measured: 36 months
Objective response rate (ORR) in Part 1
Objective response rate as determined by RECIST 1.1
Measured: 12 months
Disease control rate (DCR)
DCR is defined as the percentage of patients who have achieved a CR, PR, or SD.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start27 Sep 2022
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anbogen Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532696
- Sponsor's protocol ID
- ABT101-102
- Status last verified
- Jun 2024
- First submitted
- 30 Aug 2022
- Last updated
- 24 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05532696
- Acronym / sponsor ID
- ABT101-102
- Keywords
- ABT-101, NSCLC, HER2 Mutations
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Anbogen Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABT-101 | Experimental | Drug: ABT-101Part 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT-101Also: DBPR112Patients will receive ABT-101 by oral administration on a 28-day cycle | Drug | ABT-101 |
Primary outcome
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
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
7 secondary outcomes
Maximum plasma concentration (Cmax) ABT-101
Time frame: 48 months
Area under the plasma concentration time curve (AUC) of ABT-101
Time frame: 48 months
Duration of response (DOR)
Time frame: 48 months
Progression- free survival (PFS)
Time frame: 36 months
Overall survival (OS)
Time frame: 36 months
Objective response rate (ORR) in Part 1
Time frame: 12 months
Disease control rate (DCR)
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ABT-101 in people with Advanced Solid Tumor and Non Small Cell Lung Cancer, run by Anbogen Therapeutics, Inc. at 5 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anbogen (+886-2-2742-1839, clinicaltrial@anbogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the recommended Phase 2 Dose (RP2D) of ABT-101 in Part 1 (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024; AzTrials last refreshed its copy on 27 Oct 2026.