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This is the first human study to use X-396 (ensartinib), a drug being developed for treatment of advanced cancers. The initial purpose of the study is to determine the largest amount of X-396 that can be safely given to humans (the maximum tolerated dose). Once the recommended Phase 2 dose has been determined, an expansion phase will assess the preliminary anti-tumor activity of X-396 in ALK-positive non-small cell lung cancer. The study will also provide early information on how the body handles the drug (pharmacokinetics) and on the efficacy of X-396.
This is the first study of X-396 (ensartinib) in humans and the investigational drug will be given as a once or twice daily oral dose in 28 day cycles until there is disease progression or unacceptable safety issues. X-396 will be given to small groups of patients (1 - 6) at each dose level and the patients will be observed to see if there are any adverse safety effects. As long as there are no unacceptable safety issues after 28 days, the dose of X-396 will be increased for the next group of patients. This process will continue until the maximum tolerated dose (MTD) of X-396 is reached. Once the MTD is reached, up to 170 additional patients will also be given X-396 to further determine the activity of X-396 in patients with ALK-positive non-small cell lung cancer. These additional patients will be enrolled in the following expansion cohorts: ALK TKI-naïve patients, patients that progressed on crizotinib, patients that progressed on one or more 2nd generation ALK TKIs (patients may or may not have also received prior crizotinib), including patients with asymptomatic CNS metastases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I: X-396 (ensartinib) | Experimental | Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops |
|
| Phase II: X-396 (ensartinib) | Experimental | RP2D 225mg stratified based on prior treatment and CNS activity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phase I: X-396 (ensartinib) | Drug | Oral, ALK inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | To evaluate the safety/tolerability of X-396 (ensartinib) and determine the maximum tolerated dose (MTD) of X-396 as a single agent. | 28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Preliminary Tumor Response in ALK Positive Patients at 225 mg QD | To explore the preliminary clinical tumor response after treatment with X-396 (ensartinib) given as a single agent in ALK positive patients at 225 mg QD. Subjects were assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria (and CNS lesions were also assessed by modified Response Assessment in Neuro-Oncology). Assessments by CT or MRI were performed after every even cycle of treatment. All assessments were to be performed within 7 days of the scheduled day of assessment. Tumor lesions followed on physical examination must have been assessed on Day 1 of each cycle and at the End-of-Study Treatment Visit. |
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Inclusion Criteria:
Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy. Patients may be ALK TKI-naive or may have received prior crizotinib and/or second generation ALK TKIs. In addition, patients with a known ALK 1198 mutation will be allowed.
-For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations; however, patients will be allowed to enroll based on local FDA-approved ALK results.
Eastern Cooperative Group ECOG) Performance Status score of 0 or 1.
Ability to swallow and retain oral medication.
Adequate organ system function.
Patients with treated or untreated asymptomatic CNS metastases may be allowed to enroll.
Male patients willing to use adequate contraceptive measures.
Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures.
Patients must be ≥ 18 years of age.
Patients must have measurable or evaluable disease for the dose escalation portion of the study and measurable disease for the expanded cohort portion of the study (except for patients in the CNS metastases and leptomeningeal cohorts).
Willingness and ability to comply with the trial and follow-up procedures.
Ability to understand the nature of this trial and give written informed consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Med Ctr | Duarte | California | 91010 | United States | ||
| UCSD Moores Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21613408 | Background | Lovly CM, Heuckmann JM, de Stanchina E, Chen H, Thomas RK, Liang C, Pao W. Insights into ALK-driven cancers revealed through development of novel ALK tyrosine kinase inhibitors. Cancer Res. 2011 Jul 15;71(14):4920-31. doi: 10.1158/0008-5472.CAN-10-3879. Epub 2011 May 25. | |
| 29563138 | Result | Horn L, Infante JR, Reckamp KL, Blumenschein GR, Leal TA, Waqar SN, Gitlitz BJ, Sanborn RE, Whisenant JG, Du L, Neal JW, Gockerman JP, Dukart G, Harrow K, Liang C, Gibbons JJ, Holzhausen A, Lovly CM, Wakelee HA. Ensartinib (X-396) in ALK-Positive Non-Small Cell Lung Cancer: Results from a First-in-Human Phase I/II, Multicenter Study. Clin Cancer Res. 2018 Jun 15;24(12):2771-2779. doi: 10.1158/1078-0432.CCR-17-2398. Epub 2018 Mar 21. |
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A total of 131 subjects were treated at 16 sites in the US, including 37 subjects in the escalation cohorts and 94 subjects in the expansion cohort.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I: X-396 (Ensartinib) at 25 mg | Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| FG001 | Phase I: X-396 (Ensartinib) at 50 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 29, 2018 | Dec 6, 2024 |
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| Phase II: X-396 (ensartinib) | Drug | Expanded Cohort |
|
|
| 18 months |
| Plasma Concentrations Cmax for Day 1 | To characterize the preliminary pharmacokinetics including Cmax f X-396 given as a single agent | 24 hours |
| Plasma Tmax on Day 1 | To characterize the preliminary pharmacokinetics including T max of X-396 given as a single agent | 24 hours |
| Plasma Concentrations AUC on Day 1 | To characterize the preliminary pharmacokinetics including AUC of X-396 given as a single agent | 0, 0.5h, 1.0h , 2.0 h, 4.0h, 6.0h, 8.0h, 24.0h, |
| Plasma Concentrations Half-life on Day 1 | To characterize the preliminary pharmacokinetics including half life of X-396 given as a single agent | 24 hours |
| La Jolla |
| California |
| 92093 |
| United States |
| University of Southern California Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University | Nashville | Tennessee | 37240 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Wisconsin Carbone Cancer Ctr | Madison | Wisconsin | 53792 | United States |
Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| FG002 | Phase I: X-396 (Ensartinib) at 100 mg | Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| FG003 | Phase I: X-396 (Ensartinib) at 200 mg | Dose escalation starting at 200 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| FG004 | Phase I: X-396 (Ensartinib) at 225 mg | Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| FG005 | Phase I: X-396 (Ensartinib) at 250 mg | Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| FG006 | Phase II: X-396 (Ensartinib) at 225 mg | Dose expansion starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase II: X-396 (ensartinib): Oral, ALK inhibitor |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I: X-396 (Ensartinib) 25 mg | Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| BG001 | Phase I: X-396 (Ensartinib) 50 mg | Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| BG002 | Phase I: X-396 (Ensartinib) 100 mg | Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| BG003 | Phase I: X-396 (Ensartinib) 200 mg | Dose escalation starting at 200 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| BG004 | Phase I: X-396 (Ensartinib) 225 mg | Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| BG005 | Phase I: X-396 (Ensartinib) 250 mg | Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| BG006 | Phase II: X-396 (Ensartinib) 225 mg | Dose exxpansion at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase II: X-396 (ensartinib): Oral, ALK inhibitor |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| ECOG Performance Status | The ECOG (Eastern Cooperative Oncology Group) Performance Status is a scale 0: Fully active, normal
| Number | # of patients with Score Grade (0-5) |
| |||||||||||||||
| Tobacco user | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose | To evaluate the safety/tolerability of X-396 (ensartinib) and determine the maximum tolerated dose (MTD) of X-396 as a single agent. | Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to at least 1 prior standard regimen for advanced disease or for which there is no approved therapy or for patients that decline standard therapy.Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1. For Phase study, patients must have NSCLC with ALK genomic alterations. | Posted | Number | mg | 28 Days |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Preliminary Tumor Response in ALK Positive Patients at 225 mg QD | To explore the preliminary clinical tumor response after treatment with X-396 (ensartinib) given as a single agent in ALK positive patients at 225 mg QD. Subjects were assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria (and CNS lesions were also assessed by modified Response Assessment in Neuro-Oncology). Assessments by CT or MRI were performed after every even cycle of treatment. All assessments were to be performed within 7 days of the scheduled day of assessment. Tumor lesions followed on physical examination must have been assessed on Day 1 of each cycle and at the End-of-Study Treatment Visit. | The Tumor response evaluation population (Recommended Phase 2 Dose only) consisted of subjects who were ALK+ at 225 mg QD, completed at least 1 cycle of treatment, and had a post-baseline response assessment. | Posted | Number | 95% Confidence Interval | participants | 18 months |
|
| ||||||||||||||||||||||||||
| Secondary | Plasma Concentrations Cmax for Day 1 | To characterize the preliminary pharmacokinetics including Cmax f X-396 given as a single agent | Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to at least 1 prior standard regimen for advanced disease or for which there is no approved therapy or for patients that decline standard therapy.For Phase II of the study, patients must have NSCLC with ALK genomic alterations. | Posted | Geometric Mean | Standard Deviation | ng/ml | 24 hours |
| |||||||||||||||||||||||||||
| Secondary | Plasma Tmax on Day 1 | To characterize the preliminary pharmacokinetics including T max of X-396 given as a single agent | Posted | Median | Full Range | hour | 24 hours |
| ||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations AUC on Day 1 | To characterize the preliminary pharmacokinetics including AUC of X-396 given as a single agent | Posted | Geometric Mean | Standard Deviation | h·ng/mL | 0, 0.5h, 1.0h , 2.0 h, 4.0h, 6.0h, 8.0h, 24.0h, |
| ||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations Half-life on Day 1 | To characterize the preliminary pharmacokinetics including half life of X-396 given as a single agent | Posted | Geometric Mean | Standard Deviation | hour | 24 hours |
|
From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I: X-396 (Ensartinib) at 25 mg | Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor | 0 | 4 | 1 | 4 | 3 | 4 |
| EG001 | Phase I: X-396 (Ensartinib) at 50 mg | Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Phase I: X-396 (Ensartinib) at 100 mg | Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor | 1 | 5 | 2 | 5 | 4 | 5 |
| EG003 | Phase I: X-396 (Ensartinib) at 200 mg | Dose escalation starting at 200 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor | 1 | 11 | 6 | 11 | 9 | 11 |
| EG004 | Phase I: X-396 (Ensartinib) at 225 mg | Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor | 0 | 4 | 2 | 4 | 2 | 4 |
| EG005 | Phase I: X-396 (Ensartinib) at 250 mg | Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor | 0 | 10 | 5 | 10 | 9 | 10 |
| EG006 | Phase II: X-396 (Ensartinib) at 225 mg | Dose expansion starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase II: X-396 (ensartinib): Oral, ALK inhibitor | 3 | 94 | 41 | 94 | 84 | 94 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Blood and lymphatic system | Blood and lymphatic system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cardiac disorders | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Acute myocardial infraction | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Atrial fibrilation | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
| |
| Metabolism and connective tissue disorders | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Muscoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Nervous system disorders | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Infections and infestations | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
| |
| Blood Creatinine increased | Investigations | MedDRA (15.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Operations | Xcovery Holdings, Inc. | +1-561-835-9356 | Esteban@xcovery.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 10, 2019 | Dec 6, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000629294 | ensartinib |
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| Between 18 and 65 years |
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| >=65 years |
|
| Male |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 |
|
| 2 |
|
| Not Determined |
|
| Former |
|
| Current |
|
|
| OG003 | Phase I: X-396 (Ensartinib) at 100 mg | Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| OG004 | Phase I: X-396 (Ensartinib) at 200 mg (Fasted) | Dose escalation starting at 200 mg (fasted), oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| OG005 | Phase I: X-396 (Ensartinib) at 250mg | Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| OG006 | Phase I: X-396 (Ensartinib) at 225mg | Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| OG007 | Phase II: X-396 (Ensartinib) at 225 mg (Fed) | RP2D 225 mg (fed) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations. Phase II: X-396 (ensartinib): Expanded Cohort |
| OG008 | Phase I: X-396 (Ensartinib) at 200 mg (Fed) | Dose escalation starting at 200 mg (fed), oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
|
|
| OG004 | Phase I: X-396 (Ensartinib) at 200 mg (Fasted) | Dose escalation starting at 200 mg (fasted), oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| OG005 | Phase I: X-396 (Ensartinib) at 250mg | Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| OG006 | Phase I: X-396 (Ensartinib) at 225mg | Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| OG007 | Phase II: X-396 (Ensartinib) at 225 mg (Fed) | RP2D 225 mg (fed) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations. Phase II: X-396 (ensartinib): Expanded Cohort |
| OG008 | Phase I: X-396 (Ensartinib) at 200 mg (Fed) | Dose escalation starting at 200 mg (fed), oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
|
|
Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops
Phase I: X-396 (ensartinib): Oral, ALK inhibitor
| OG004 | Phase I: X-396 (Ensartinib) at 200 mg (Fasted) | Dose escalation starting at 200 mg (fasted), oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| OG005 | Phase I: X-396 (Ensartinib) at 250mg | Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| OG006 | Phase I: X-396 (Ensartinib) at 225mg | Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| OG007 | Phase II: X-396 (Ensartinib) at 225 mg (Fed) | RP2D 225 mg (fed) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations. Phase II: X-396 (ensartinib): Expanded Cohort |
| OG008 | Phase I: X-396 (Ensartinib) at 200 mg (Fed) | Dose escalation starting at 200 mg (fed), oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
|
|
| OG004 | Phase I: X-396 (Ensartinib) at 200 mg (Fasted) | Dose escalation starting at 200 mg (fasted), oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| OG005 | Phase I: X-396 (Ensartinib) at 250mg | Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| OG006 | Phase I: X-396 (Ensartinib) at 225mg | Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
| OG007 | Phase II: X-396 (Ensartinib) at 225 mg (Fed) | RP2D 225 mg (fed) For the expanded cohort portion of the study, patients must have NSCLC with ALK genomic alterations. Phase II: X-396 (ensartinib): Expanded Cohort |
| OG008 | Phase I: X-396 (Ensartinib) at 200 mg (Fed) | Dose escalation starting at 200 mg (fed), oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor |
|
|