Solid TumorPhase 2NCT04617054
Phase II Study of AB-106 to Treat Patients With Solid Tumors With NTRK Gene Fusion
A Phase 2 study testing AB-106 in people with Solid Tumor, run by Nuvation Bio Inc. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- AB-106
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 6 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 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:
- Must have received previous treatment, including radiotherapy (with clear progression before C1D1), chemotherapy, and targeted therapy (completed at least 4 weeks before C1D1).
- At least 1 lesion must be measurable in two dimensions (confirmed by MRI and assessable as per RANO criteria), and each dimension of at least 1 measurable lesion must be ≥1 cm, and can be observed on more than 1 imaging slice.
Show all 18Show fewer
- 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;
- 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):
- Absolute neutrophil count ≥1.5×109/L, platelets ≥80×109/L, and hemoglobin ≥90 g/L.
- Serum AST and serum ALT ≤2.5×the upper limit of normal (ULN); AST and ALT ≤5×ULN for participants with liver tumors.
- Total bilirubin ≤1.5×ULN. Participants with a known history of Gilbert's syndrome and an abnormal increase in indirect bilirubin are eligible.
- Serum creatinine ≤2.0×ULN; urine dipstick for urine protein <2+; if ≥2+, a 24-hour urine protein should be quantified and total urine protein <1 g.
- Coagulation: International normalized ratio (INR) ≤1.5, and partial prothrombin time or activated partial thromboplastin time (APTT) ≤1.5×ULN;
- Participants must have been able to provide archived or newly obtained tumor tissue specimens (including consent for the collection of new biopsy specimens);
- During the treatment period and for at least 90 days after completing study drug, participants agreed to use effective contraceptive measures (excluding males post-vasectomy, or females who were post-sterilization and postmenopausal). Women of childbearing potential were required to have a negative blood human chorionic gonadotropin (HCG) test within 7 days prior to the first dose;
- Prior to enrollment, participants (or their legal representatives) had been fully informed and had signed and dated the informed consent form (ICF).
Who cannot join
- 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;
Show all 18Show fewer
- 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);
- History of immunodeficiency, including testing positive for HIV or suffering from other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
- Participants who were expected to use systemic strong inhibitors of CYP3A4 within 28 days prior to the start of the study drug and/or during the study period, including, but not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, or strong inducers of CYP3A4, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's Wort, or strong inducers or inhibitors of p-gp;
- Participants with a history of other malignancies. This did not include those who were cured of non-melanoma skin cancer, carcinoma in situ of the cervix, or prostate intraepithelial neoplasm. Participants diagnosed with other malignancies more than 5 years before enrollment could be included only if: (i) there were no active lesions, (ii) the Investigator assessed the risk of recurrence as low, and (iii) the condition would not interfere with the assessment of the efficacy of taletrectinib;
- Participants who, in the Investigator's judgment, had other serious acute or chronic physical illnesses, mental illnesses, or laboratory abnormalities, as well as diseases or abnormalities that might pose an excessive risk in relation to participation in the study or administration of the study drug;
- Expected to use any other antitumor drugs within 14 days prior to starting the study drug and/or during the study, including traditional Chinese medicines, Chinese patent drugs, and herbal medicines (including decoctions) with clear antitumor indications in the package inserts;
- Participants with a known history of neurological or psychiatric disorders, such as epilepsy or dementia, that may affect compliance;
- Participants with a history of drug or substance abuse;
- Participants with spinal cord compression due to the tumor (unless the participant's pain is fully controlled and neurological function is stable or restored), cancerous meningitis, or leptomeningeal disease; those assessed by the Investigator to be at risk for brain herniation;
- Participants with active peptic ulcers, significant vomiting, chronic diarrhea, intestinal obstruction, malabsorption, or other known diseases that could affect drug absorption; those with swallowing difficulties or other severe conditions that significantly affect drug absorption, such as those who have undergone gastric or intestinal resection;
- Participants with a history or current conditions within 3 months prior to enrollment: heart failure (New York Heart Association functional classification ≥3), myocardial infarction, cerebral infarction, unstable angina, arrhythmias requiring treatment, uncontrollable atrial fibrillation (of any grade), coronary or peripheral artery disease, pulmonary embolism, uncontrollable deep vein thrombosis, or other clinically significant severe thrombosis, or autoimmune diseases requiring treatment; or whose ECG showed a QTc >470 ms (females) or QTc >450 ms (males) before enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Multicenter, Open, Basket Study of AB-106 to Treat the Subjects With Local Progression or Systemic Metastasis Solid Tumors With NTRK Gene Fusion
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.
- Conditions
- Solid Tumor
- Being tested
- AB-106
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-106Drug
600mg QD for each subjects.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm trial whereby all consented, enrolled, eligible patients receive AB-106 | Experimental | Not described Receives: Drug: AB-106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Assessed by an Independent Review Committee (IRC) based on the RECIST 1.1 criteria or the RANO criteria.
Measured: Approximately 24 months
Secondary outcomes (12)
Objective response rate (ORR)
Assessed by the Investigator based on RECIST 1.1 or RANO criteria.
Measured: Approximately 24 months
Duration of response (DOR)
Assessed separately by the IRC and the Investigator based on RECIST 1.1 or RANO criteria.
Measured: Approximately 24 months
Time to Response (TTR)
Assessed separately by the IRC and the Investigator based on RECIST 1.1 or RANO criteria
Measured: Approximately 24 months
Time to Progress (TTP)
Assessed separately by the IRC and the Investigator based on RECIST 1.1 or RANO criteria.
Measured: Approximately 24 months
Disease control rate (DCR)
Assessed separately by the IRC and the Investigator based on RECIST 1.1 or RANO criteria.
Measured: Approximately 24 months
Intracranial objective response rate (IC-ORR)
Assessed by the IRC based on the RANO-BM criteria for participants with brain metastases at baseline.
Measured: Approximately 24 months
Intracranial duration of response (IC-DOR)
Assessed by the IRC based on the RANO-BM criteria for participants with brain metastases at baseline.
Measured: Approximately 24 months
Intracranial disease control rate (IC-DCR)
Assessed by the IRC based on the RANO-BM criteria for participants with brain metastases at baseline.
Measured: Approximately 24 months
Progression free Survival (PFS)
Progression free Survival (PFS) as assessed separately by the IRC and the Investigator based on RECIST 1.1 or RANO criteria.
Measured: Approximately 30 months
Overall survival (OS)
Assessed by Kaplan-Meier method.
Measured: Approximately 36 months
Safety and tolerability of taletrectinib treatment
Adverse events (AEs)/Serious adverse events (SAEs)/Adverse events of special interests (AESIs); laboratory tests, vital signs, physical examination, ophthalmological examination, 12-lead electrocardiogram (ECG), etc.
Measured: Approximately 36 months
Pharmacokinetics (PK) of taletrectinib
Plasma concentrations of taletrectinib (in free form)
Measured: Cycle 1 Day 1 to Cycle 2 Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Jun 2021
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Why it stopped: The study was discontinued early by the Sponsor for business reasons on 06 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuvation Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AnHeart Therapeutics Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617054
- Sponsor's protocol ID
- AB-106-C205
- Status last verified
- Jan 2026
- First submitted
- 30 Oct 2020
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Open, Basket Study of AB-106 to Treat the Subjects With Local Progression or Systemic Metastasis Solid Tumors With NTRK Gene Fusion
- ClinicalTrials.gov ID
- NCT04617054
- Acronym / sponsor ID
- AB-106-C205
- Conditions
- Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was discontinued early by the Sponsor for business reasons on 06 Dec 2024
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Nuvation Bio Inc.Industry (pharma, biotech, devices)
- Collaborators
- AnHeart Therapeutics Inc.
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 5 Nov 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm trial whereby all consented, enrolled, eligible patients receive AB-106 | Experimental | Drug: AB-106 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
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 |
|---|---|---|
| AB-106600mg QD for each subjects. | Drug | Single-arm trial whereby all consented, enrolled, eligible patients receive AB-106 |
Primary outcome
Objective response rate (ORR)
Time frame: Approximately 24 months
Assessed by an Independent Review Committee (IRC) based on the RECIST 1.1 criteria or the RANO criteria.
12 secondary outcomes
Objective response rate (ORR)
Time frame: Approximately 24 months
Duration of response (DOR)
Time frame: Approximately 24 months
Time to Response (TTR)
Time frame: Approximately 24 months
Time to Progress (TTP)
Time frame: Approximately 24 months
Disease control rate (DCR)
Time frame: Approximately 24 months
Intracranial objective response rate (IC-ORR)
Time frame: Approximately 24 months
Intracranial duration of response (IC-DOR)
Time frame: Approximately 24 months
Intracranial disease control rate (IC-DCR)
Time frame: Approximately 24 months
Progression free Survival (PFS)
Time frame: Approximately 30 months
Overall survival (OS)
Time frame: Approximately 36 months
Safety and tolerability of taletrectinib treatment
Time frame: Approximately 36 months
Pharmacokinetics (PK) of taletrectinib
Time frame: Cycle 1 Day 1 to Cycle 2 Day 1
Results and safety
The study was stopped early (reason given: The study was discontinued early by the Sponsor for business reasons on 06 Dec 2024). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AB-106 in people with Solid Tumor, run by Nuvation Bio Inc. at 1 site in China.
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 18 inclusion and 18 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: stopped early, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 phase mean?
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?
The study was stopped early (reason given: The study was discontinued early by the Sponsor for business reasons on 06 Dec 2024). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Approximately 24 months). 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 21 Jan 2026.