Informations générales (source: ClinicalTrials.gov)
A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients with Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors
Interventional
Phase 2
Nuvation Bio Inc. (Voir sur ClinicalTrials)
septembre 2021
juin 2027
13 septembre 2025
The main purpose of the study is to evaluate safety and efficacy of taletrectinib (also
known as AB-106 or DS-6051b) monotherapy in the treatment of advanced NSCLC.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Benjamin BESSE | 21/06/2024 15:51:36 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Léon Bérard - Lyon - France | Contact (sur clinicalTrials) | ||||
| CHU de Grenoble - Hôpital Albert Michallon - Grenoble - France | Contact (sur clinicalTrials) | ||||
| CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel - Bron - France | Contact (sur clinicalTrials) | ||||
| CHU Poitiers - Hopital la Miletrie - Poitiers - France | Contact (sur clinicalTrials) | ||||
| CHU Rennes - Hopital Pontchaillou - Rennes - France | Contact (sur clinicalTrials) | ||||
| Godinot Cancer Institute - Reims - France | Contact (sur clinicalTrials) | ||||
| Hôpital Nord - CHU Marseille - Marseille - France | Contact (sur clinicalTrials) | ||||
| ICO - Site René Gauducheau - Nantes - France | Contact (sur clinicalTrials) | ||||
| Institut Gustave Roussy - Villejuif - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Age ≥18 years (or ≥20 years as required by local regulations).
2. Histologically or cytologically confirmed diagnosis of locally advanced (including
inoperable Stage IIIA or IIIB NSCLC) or metastatic NSCLC or other solid tumors.
3. Evidence of ROS1 fusion by a validated assay.
4. Patients with central nervous system (CNS) involvement, including leptomeningeal
carcinomatosis, must be stable, either asymptomatic or previously treated and
controlled within 14 days of first dose.
5. The patient can be either ROS1 TKI treatment naïve or treated with prior ROS1
TKI(s).
6. The patient must have at least 1 measurable disease per RECIST 1.1 as assessed by
the investigator.
7. Eastern Cooperative Oncology Group Performance Status: 0 or 1.
8. Patient with a life expectancy ≥12 weeks based on the judgement of investigator.
9. Patients with adequate organ function meeting the following criteria:
1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): ≤3.0 ×
upper limit of normal (ULN) (or ≤5.0 × ULN, for patients with concurrent liver
metastases)
2. Serum total bilirubin: ≤1.5 × ULN (≤3.0 × ULN for patients with Gilbert
syndrome or if liver function abnormalities are due to underlying malignancy)
3. Absolute neutrophil count: ≥1,500/μL
4. Platelet count: ≥100,000/μL
5. Hemoglobin: ≥9.0 g/dL
6. Serum creatinine ≤1.5 × ULN
10. Patients must be able to practice required contraception during the study.
1. For males (irrespective of surgical sterilization [vasectomy]): agree to use
effective contraception methods during the study intervention period and for at
least 90 days after the last dose of investigational drug or agree with
complete abstinence.
2. Females without menses for at least 1 year prior to screening or documented to
be surgically sterilized. Women of childbearing potential (WOCBP) must agree to
use two concurrent highly effective methods of contraception or agree with
complete abstinence from sexual intercourse since the informed consent until 45
days after the last dose of investigational drug. The patient is willing and
capable to give written informed consent.
11. The patient is willing and capable to comply with the study scheduled visits,
treatment plans, laboratory tests and other procedures.
12. The patient is willing and capable to comply with study site's COVID-19 policies.
Exclusion Criteria
1. Treatment with small molecule anticancer therapy including other investigational
agents or cytotoxic systemic anticancer therapy within 2 weeks (or 5 half-lives of
the compound, whichever is shorter) prior to the first dose of taletrectinib;
Treatment with immuno-oncology (IO) including immune checkpoint inhibitors within 4
weeks before the first dose of taletrectinib.
2. Major surgical procedure, open biopsy, or significant traumatic injury ≤4 weeks
before the first dose of taletrectinib.
• Placement of vascular access device is not considered major surgery. Other minor
surgical procedures, such as catheter placement or minimally invasive biopsy, are
allowed.
3. Radiotherapy within 14 days before study treatment. Stereotactic radiosurgery (SRS),
stereotactic radiation therapy (SRT), and palliative radiation outside the chest and
brain are allowed but must be completed 1 week before starting study treatment.
4. Have been diagnosed with another primary malignancy other than NSCLC except for
adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively
treated non-metastatic prostate cancer; or patients with another primary malignancy
who are definitively relapse-free with at least 3 years elapsed since the diagnosis
of the other primary malignancy.
5. Adverse events due to prior therapy are unresolved to ≤ CTCAE Grade 1 or has not
returned to baseline, by the first dose of taletrectinib except for AEs not
constituting a safety risk to the patient based on the judgment of investigators.
6. Patients with untreated spinal cord compression caused by tumor and/or cancerous
meningitis.
7. History or evidence of interstitial fibrosis, interstitial lung disease or
drug-induced pneumonitis.
8. Any gastrointestinal disorders that may affect absorption of oral medications.
9. Active and clinically significant bacterial, fungal, or viral infection including
hepatitis B virus (HBV), hepatitis C virus (HCV), or severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2), known human immunodeficiency virus (HIV) or
acquired immunodeficiency syndrome (AIDS)-related illness.
10. Clinically significant cardiovascular diseases within 3 months prior to the first
dose of taletrectinib: myocardial infarction, severe/unstable angina,
coronary/peripheral endovascular treatment, heart failure or cerebrovascular
disorder including transient ischemic attack.
11. Ongoing cardiac dysrhythmias of ≥ CTCAE Grade 2, uncontrolled atrial fibrillation of
any grade, or QT interval corrected for heart rate by Fredericia's formula (QTcF)
>470 milliseconds, or symptomatic bradycardia <45 beats per minute; patient has
family or medical history of long QT syndrome.
12. Pregnancy or lactation/breastfeeding.
13. Use of food or drugs that are known potent cytochrome P450 3A4/5 (CYP3A4/5)
inhibitors or inducers or P-glycoprotein inhibitors or inducers within 14 days prior
to the first dose of study treatment and while on treatment.
14. Administration of agents with potential QT interval prolonging effect within 14 days
prior to first dose of study treatment and while on treatment.
15. Patients with other severe medical or mental diseases in whom the risk is increased
by the participation to the study or treatment with study treatment in the opinion
of the investigator.
1. Age ≥18 years (or ≥20 years as required by local regulations).
2. Histologically or cytologically confirmed diagnosis of locally advanced (including
inoperable Stage IIIA or IIIB NSCLC) or metastatic NSCLC or other solid tumors.
3. Evidence of ROS1 fusion by a validated assay.
4. Patients with central nervous system (CNS) involvement, including leptomeningeal
carcinomatosis, must be stable, either asymptomatic or previously treated and
controlled within 14 days of first dose.
5. The patient can be either ROS1 TKI treatment naïve or treated with prior ROS1
TKI(s).
6. The patient must have at least 1 measurable disease per RECIST 1.1 as assessed by
the investigator.
7. Eastern Cooperative Oncology Group Performance Status: 0 or 1.
8. Patient with a life expectancy ≥12 weeks based on the judgement of investigator.
9. Patients with adequate organ function meeting the following criteria:
1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): ≤3.0 ×
upper limit of normal (ULN) (or ≤5.0 × ULN, for patients with concurrent liver
metastases)
2. Serum total bilirubin: ≤1.5 × ULN (≤3.0 × ULN for patients with Gilbert
syndrome or if liver function abnormalities are due to underlying malignancy)
3. Absolute neutrophil count: ≥1,500/μL
4. Platelet count: ≥100,000/μL
5. Hemoglobin: ≥9.0 g/dL
6. Serum creatinine ≤1.5 × ULN
10. Patients must be able to practice required contraception during the study.
1. For males (irrespective of surgical sterilization [vasectomy]): agree to use
effective contraception methods during the study intervention period and for at
least 90 days after the last dose of investigational drug or agree with
complete abstinence.
2. Females without menses for at least 1 year prior to screening or documented to
be surgically sterilized. Women of childbearing potential (WOCBP) must agree to
use two concurrent highly effective methods of contraception or agree with
complete abstinence from sexual intercourse since the informed consent until 45
days after the last dose of investigational drug. The patient is willing and
capable to give written informed consent.
11. The patient is willing and capable to comply with the study scheduled visits,
treatment plans, laboratory tests and other procedures.
12. The patient is willing and capable to comply with study site's COVID-19 policies.
Exclusion Criteria
1. Treatment with small molecule anticancer therapy including other investigational
agents or cytotoxic systemic anticancer therapy within 2 weeks (or 5 half-lives of
the compound, whichever is shorter) prior to the first dose of taletrectinib;
Treatment with immuno-oncology (IO) including immune checkpoint inhibitors within 4
weeks before the first dose of taletrectinib.
2. Major surgical procedure, open biopsy, or significant traumatic injury ≤4 weeks
before the first dose of taletrectinib.
• Placement of vascular access device is not considered major surgery. Other minor
surgical procedures, such as catheter placement or minimally invasive biopsy, are
allowed.
3. Radiotherapy within 14 days before study treatment. Stereotactic radiosurgery (SRS),
stereotactic radiation therapy (SRT), and palliative radiation outside the chest and
brain are allowed but must be completed 1 week before starting study treatment.
4. Have been diagnosed with another primary malignancy other than NSCLC except for
adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively
treated non-metastatic prostate cancer; or patients with another primary malignancy
who are definitively relapse-free with at least 3 years elapsed since the diagnosis
of the other primary malignancy.
5. Adverse events due to prior therapy are unresolved to ≤ CTCAE Grade 1 or has not
returned to baseline, by the first dose of taletrectinib except for AEs not
constituting a safety risk to the patient based on the judgment of investigators.
6. Patients with untreated spinal cord compression caused by tumor and/or cancerous
meningitis.
7. History or evidence of interstitial fibrosis, interstitial lung disease or
drug-induced pneumonitis.
8. Any gastrointestinal disorders that may affect absorption of oral medications.
9. Active and clinically significant bacterial, fungal, or viral infection including
hepatitis B virus (HBV), hepatitis C virus (HCV), or severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2), known human immunodeficiency virus (HIV) or
acquired immunodeficiency syndrome (AIDS)-related illness.
10. Clinically significant cardiovascular diseases within 3 months prior to the first
dose of taletrectinib: myocardial infarction, severe/unstable angina,
coronary/peripheral endovascular treatment, heart failure or cerebrovascular
disorder including transient ischemic attack.
11. Ongoing cardiac dysrhythmias of ≥ CTCAE Grade 2, uncontrolled atrial fibrillation of
any grade, or QT interval corrected for heart rate by Fredericia's formula (QTcF)
>470 milliseconds, or symptomatic bradycardia <45 beats per minute; patient has
family or medical history of long QT syndrome.
12. Pregnancy or lactation/breastfeeding.
13. Use of food or drugs that are known potent cytochrome P450 3A4/5 (CYP3A4/5)
inhibitors or inducers or P-glycoprotein inhibitors or inducers within 14 days prior
to the first dose of study treatment and while on treatment.
14. Administration of agents with potential QT interval prolonging effect within 14 days
prior to first dose of study treatment and while on treatment.
15. Patients with other severe medical or mental diseases in whom the risk is increased
by the participation to the study or treatment with study treatment in the opinion
of the investigator.