Phase II Study of AB-106 to Treat Patients With Solid Tumors With NTRK Gene Fusion (NCT04617054) | Clinical Trial Compass
TerminatedPhase 2
Phase II Study of AB-106 to Treat Patients With Solid Tumors With NTRK Gene Fusion
Stopped: The study was discontinued early by the Sponsor for business reasons on 06 Dec 2024
China14 participantsStarted 2021-06-01
Plain-language summary
AB-106 will be administered once a day. Each treatment cycle is defined as 21 days of continuous medication. Dosing will continue until any of the following conditions are met: disease progression, intolerable drug-related adverse events, researchers recommend discontinuation of treatment, withdrawal of informed consent, pregnancy during the study, use of other anti-tumor therapy, loss of follow-up, death and other causes, whichever occurs first.
The study includes a screening period, treatment period, safety follow-up and long-term follow-up.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosed with locally advanced or metastatic solid tumors harboring NTRK1, NTRK2, or NTRK3 fusion genes (anticipated to translate into fusion proteins with a functional TrkA/B/C kinase domain);
. Participants who had failed standard of care or refused standard of care;
. Participants must have had at least 1 measurable lesion as defined by RECIST 1.1;
. For participants diagnosed with a primary CNS tumor, the following criteria should have been met:
. Male or female participants ≥18 years old;
. ECOG PS score of ≤1;
. The Investigator judged that the participant's life expectancy was more than 3 months;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Within 7 days prior to enrollment, laboratory tests had to meet the following criteria (requiring no blood or blood product transfusion, no use of hematopoietic stimulants, or other medications to correct blood cells within 14 days prior to enrollment):
Exclusion criteria
. Underwent treatment in another therapeutic clinical study within 4 weeks prior to the first dose of taletrectinib;
. Participants who had suffered a cerebrovascular accident (excluding transient ischemic attacks) within 3 months before enrollment;
. Participants with Grade ≥2 toxicity reactions from previous treatments which did not resolve, except for AEs deemed as not posing a safety risk (such as alopecia, neuropathy, and specific laboratory test abnormalities);
. Participants with symptomatic or unstable brain metastases (participants with asymptomatic brain metastases may be eligible), and those with primary CNS tumors may be included if their condition was stable for at least 7 days;
. Participants who underwent major surgery or radiotherapy within 28 days prior to enrollment (participants who received palliative radiotherapy for bone metastasis pain and brain metastasis radiotherapy within 2 weeks before enrollment were allowed to participate), or participants who were expected to require major surgery during the study;
. Known interstitial lung disease, interstitial fibrosis, or pneumonitis induced by tyrosine kinase inhibitors;
. Participants with active, uncontrollable systemic bacterial, viral, or fungal infections, or diseases such as diabetes or hypertension unmanageable with medication, or other systemic diseases that would hinder compliance with the study procedures;
. Active hepatitis B or C infection (HBsAg positive and/or HBcAb positive with HBV DNA ≥104 copies or ≥2000 IU/mL; HCV antibody positive and HCV-RNA positive or HCV-RNA\>ULN);