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New treatment option for Advanced Solid Tumor
Official title Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
ClinicalTrials.gov ID: NCT05532696
What this study is testing
What is ABT-101?
ABT-101 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Also referred to as DBPR112.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Taichung, Taiwan
- Tainan, Taiwan
- Taipei, Taiwan
- Taoyuan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taichung, Taiwan; Tainan, Taiwan; Taipei, Taiwan; Taoyuan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.