Philadelphia Positive Acute Lymphoblastic LeukemiaPhase 1NCT07614022
A Study of LP-118 In Combination With Ponatinib, Dexamethasone And Blinatumomab For Adults With Newly-Diagnosed, BCR::ABL1-Positive Acute Lymphoblastic Leukemia (ALL)
A Phase 1 study testing LP-118 in people with Philadelphia Positive Acute Lymphoblastic Leukemia, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
The purpose of this research study is to see if a drug called LP-118 is safe and effective for treating adults with Philadelphia chromosome-positive (Ph+) B cell acute lymphoblastic leukemia (ALL), when given with ponatinib, dexamethasone, methotrexate and blinatumomab (the standard treatment for this type of cancer). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Philadelphia Positive Acute Lymphoblastic Leukemia
- What is being tested?
- LP-118
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2026to Mar 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Ability to understand and willingness to sign an IRB-approved informed consent.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status (PS) ≤ 2.
- Histological or cytological confirmation of newly diagnosed CD19-positive Philadelphia-chromosome/BCR::ABL1-positive ALL.
- Creatinine clearance: ≥60 mL/min, determined by the Cockroft-Gault formula, or measured by a 24-hour urine collection.
- Bilirubin ≤ 1.5 × upper limit of normal (ULN) - Unless liver abnormalities considered due to Gilbert's syndrome or of non-hepatic origin i.e., leukemic involvement. For patients with Gilbert's syndrome, bilirubin ≤1.5 x of their baseline bilirubin level will be required.
Show all 12Show fewer
- Aspartate aminotransferase (AST) - Unless liver abnormalities considered due to Gilbert's syndrome or of non-hepatic origin i.e., leukemic involvement. For patients with Gilbert's syndrome, bilirubin ≤1.5 x of their baseline bilirubin level will be required.
- Alanine aminotransferase (ALT) - Unless liver abnormalities considered due to Gilbert's syndrome or of non-hepatic origin i.e., leukemic involvement. For patients with Gilbert's syndrome, bilirubin ≤1.5 x of their baseline bilirubin level will be required.
- Individuals of childbearing potential (ICBP) must have a negative serum pregnancy test. NOTE: Individuals who may become pregnant are considered to have childbearing potential unless they are surgically infertile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause).
- ICBP must be willing to use two forms of contraception, one of which must be a barrier method and the other must be a highly effective contraceptive method from the time of informed consent until 6 months after study treatment discontinuation. Male participants with female partners of reproductive potential will need to agree to use contraception methods described above during study treatment and for at least 6 months after completion of all study treatment.
- Male participants must agree to refrain from sperm donation during study treatment and for at least 6 months after completion of all study treatment.
- Ability to ingest oral medications without a malabsorption condition, known dysphagia, short-gut syndrome, gastroparesis, or other conditions that may limit the ingestion or gastrointestinal absorption, distribution, metabolism and excretion of drugs administered orally, per the enrolling investigator.
Who cannot join
- Any prior treatment for ALL except for a single dose of intrathecal (IT) chemotherapy, corticosteroids, hydroxyurea, a single dose of vincristine, cytarabine, leukapheresis, and/or a BCR::ABL1-targeted tyrosine kinase inhibitor. Permitted prior treatment is limited to a duration of no longer than 14 days. Permitted prior treatment must be stopped at least 24 hours prior to starting study therapy.
- Women who are pregnant, nursing, or who plan to become pregnant while in the study and for at least 6 months after the last administration of all study treatment. NOTE: breast milk cannot be stored for future use while the mother is being treated on study. Pregnant participants are excluded from this study because ponatinib, blinatumomab, and methotrexate have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ponatinib, blinatumomab, and methotrexate breastfeeding should be discontinued if the patient is treated with ponatinib, blinatumomab, and methotrexate.
- Active second malignancy except for localized prostate cancer, basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the skin or cervix.
- Unstable or severe uncontrolled medical condition in the opinion of the enrolling investigator (e.g., unstable cardiac function or unstable pulmonary condition; uncontrolled infection).
- Participants with known history of hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV) are eligible if no evidence of active viral replication by blood testing (i.e. negative viral loads). HIV positive participants must be on active anti-retroviral therapy and willing to continue therapy during study treatment.
- Uncontrolled cardiac disease as determined by the enrolling investigator.
- Major surgery, as determined by the enrolling investigator, within 2 weeks before enrollment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Atrium Health Levine Cancer
Charlotte, North Carolina, 28204
Katarzyna Wydrzynska-Gruner, RN, 704-355-2000, katarzyna.wydrzynskagruner@advocatehealth.org
Thomas Knight, MD
- Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Dianna Auman, RN, 336-716-1122, Dianna.Roesler@Advocatehealth.org
Madelyn Burkart, MD
About this study
Official title: A Phase I Study of the Bcl-2/Bcl-XL Inhibitor LP-118 In Combination With Ponatinib, Dexamethasone And Blinatumomab For Adults With Newly-Diagnosed, Philadelphia-Chromosome/BCR::ABL1-Positive Acute Lymphoblastic Leukemia
The purpose of this research study is to see if a drug called LP-118 is safe and effective for treating adults with Philadelphia chromosome-positive (Ph+) B cell acute lymphoblastic leukemia (ALL), when given with ponatinib, dexamethasone, methotrexate and blinatumomab (the standard treatment for this type of cancer).
Read the detailed description
Philadelphia-Chromosome/BCR::ABL1-Positive (Ph+) acute lymphoblastic leukemia (ALL) is a type of blood cancer that happens when a specific genetic change occurs in the DNA of certain blood cells, leading to uncontrolled growth of cells. Ph+ ALL is a more aggressive form of leukemia compared to other types but with specific medications called tyrosine kinase inhibitors, treatment outcomes have significantly improved. Unfortunately, some patients still do experience relapsed disease, when their leukemia comes back after treatment, which is challenging to treat. Therefore, research is ongoing to determine ways to improve therapy and outcomes for patients with Ph+ ALL.
The purpose of this study is to learn more about LP-118 and its side effects and decide on acceptable doses when combined with Food and Drug Administration (FDA) approved therapy for adult patients with Ph+ ALL. All participants will receive standard of care treatment for newly diagnosed Ph+ ALL consisting of the FDA approved drugs ponatinib, dexamethasone, intrathecal (injection into the spinal canal, also called "spinal tap") and systemic methotrexate and blinatumomab. This study will investigate different dose levels of LP-118 when given with his treatment combination to determine the most effective doses that can be safely given to patients with Ph+ ALL. This means that enrolled patients will receive progressive increasing or decreasing doses of LP-118 until the highest effective and safe dose is determined, while closely monitoring patients for any side effects or reactions. The highest dose is the dose that is the most effective dose that can be safely given to patients. This study will also preliminarily investigate if the addition of LP-118 improves treatment responses and outcomes for patients. If this trial is successful, the effectiveness of LP-118 added to this treatment regimen to treat Ph+ ALL will be studied in the next phase of clinical trials.
- Being tested
- LP-118
- Keywords
- Leukemia, Philadelphia-Chromosome positive, cancer
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP-118Drug
s LP-118 dosing will be dependent on the dose level to which a participant is assigned:
- 50mg PO
- 100mg PO
- 200mg PO
- 300mg PO
| Study group | Role | What they receive |
|---|---|---|
| Combination of LP-118, ponatinib, dexamethasone, blinatumomab and methotrexate | Experimental | LP-118 will be given as tablets of 10mg or 100mg during the induction II course only in combination with ponatinib, dexamethasone, methotrexate and blinatumomab. . Ponatinib, dexamethasone and methotrexate dosing will remain fixed, whereas LP-118 dosing will be dependent on the dose level to which a participant is assigned. Receives: Drug: LP-118 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the Maximum Tolerated Dose (MTD) for LP-118 (Dose Escalation)
Binary variable indicating if a Dose Limiting Toxicity (DLT) occurred.
Measured: The DLT monitoring period is from Day 1 of Course 2 until the end of Course 2 (approximately 21 days).
Identification of the Recommended Phase 2 Dose (RP2D) LP-118 (Dose Expansion)
Binary variable indicating if a Dose Limiting Toxicity (DLT) occurred.
Measured: The DLT monitoring period is from Day 1 of Course 2 until the end of Course 2 (approximately 21 days).
Secondary outcomes (10)
Overall Survival (OS).
The time from treatment administration to death from any cause, or until last contact if the patient has not died
Measured: At most 10 years.
Relapsed-Free Survival (RFS).
Time from Complete Remission (CR) or Complete Remission with Incomplete Hematologic Recovery (CRi) to disease relapse or death (whichever occurs first) or otherwise censored at the date of the last disease assessment.
Measured: At most 10 years.
Event-Free Survival (EFS).
Time from start of therapy until failure to achieve CR/CRi, relapse, or death from any cause or otherwise censored at the date of the last disease assessment.
Measured: At most 10 years.
Overall Complete Molecular Response (CMR) rate.
Binary variable indicating if a CMR at any time while on study.
Measured: At most 10 years.
Measurable Residual Disease (MRD) rate.
Binary variable indicating if MRD was achieved.
Measured: Approximately 3 years.
Isolated Central Nervous System (CNS) relapse rate.
Binary variable indicating if isolated CNS relapse occurred.
Measured: At most 10 years.
Complete Response (CR) rate.
Complete clinical remission defined as the disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blasts or extramedullary disease, with recovery of hematopoiesis defined by Absolute Neutrophil Count (ANC) ≥1000/μL and platelets ≥100,000/μL.
Measured: Approximately 3 years.
Complete clinical remission with incomplete count recovery (CRi)
Complete clinical remission with incomplete count recovery (CRi) defined as complete clinical remission except with ANC< 1000/μL and/or platelets <100,000/μL
Measured: Approximately 3 years.
Overall Response (OR) rate.
A binary variable indicating if a CR or CRi was achieved.
Measured: Approximately 3 years.
Occurrence of toxicities per Common Terminology Criteria V5.0
Binary variables indicating the occurrence of toxicities per Common Terminology Criteria V5.0.
Measured: Approximately 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startDec 2026 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Philadelphia Positive Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Newave Pharmaceutical Inc, Atrium Health Wake Forest Baptist, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Madelyn Burkart, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614022
- Sponsor's protocol ID
- IRB00127277
- Other IDs
- P30CA012197, ONC-LEUK-2405
- Status last verified
- Oct 2026
- First submitted
- 21 May 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Bcl-2/Bcl-XL Inhibitor LP-118 In Combination With Ponatinib, Dexamethasone And Blinatumomab For Adults With Newly-Diagnosed, Philadelphia-Chromosome/BCR::ABL1-Positive Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07614022
- Acronym / sponsor ID
- IRB00127277
- Keywords
- Leukemia, Philadelphia-Chromosome positive, cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Newave Pharmaceutical Inc, Atrium Health Wake Forest Baptist, National Cancer Institute (NCI)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 29 May 2026 (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.
The purpose of this research study is to see if a drug called LP-118 is safe and effective for treating adults with Philadelphia chromosome-positive (Ph+) B cell acute lymphoblastic leukemia (ALL), when given with ponatinib, dexamethasone, methotrexate and blinatumomab (the standard treatment for this type of cancer).
Detailed description
Philadelphia-Chromosome/BCR::ABL1-Positive (Ph+) acute lymphoblastic leukemia (ALL) is a type of blood cancer that happens when a specific genetic change occurs in the DNA of certain blood cells, leading to uncontrolled growth of cells. Ph+ ALL is a more aggressive form of leukemia compared to other types but with specific medications called tyrosine kinase inhibitors, treatment outcomes have significantly improved. Unfortunately, some patients still do experience relapsed disease, when their leukemia comes back after treatment, which is challenging to treat. Therefore, research is ongoing to determine ways to improve therapy and outcomes for patients with Ph+ ALL.
The purpose of this study is to learn more about LP-118 and its side effects and decide on acceptable doses when combined with Food and Drug Administration (FDA) approved therapy for adult patients with Ph+ ALL. All participants will receive standard of care treatment for newly diagnosed Ph+ ALL consisting of the FDA approved drugs ponatinib, dexamethasone, intrathecal (injection into the spinal canal, also called "spinal tap") and systemic methotrexate and blinatumomab. This study will investigate different dose levels of LP-118 when given with his treatment combination to determine the most effective doses that can be safely given to patients with Ph+ ALL. This means that enrolled patients will receive progressive increasing or decreasing doses of LP-118 until the highest effective and safe dose is determined, while closely monitoring patients for any side effects or reactions. The highest dose is the dose that is the most effective dose that can be safely given to patients. This study will also preliminarily investigate if the addition of LP-118 improves treatment responses and outcomes for patients. If this trial is successful, the effectiveness of LP-118 added to this treatment regimen to treat Ph+ ALL will be studied in the next phase of clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination of LP-118, ponatinib, dexamethasone, blinatumomab and methotrexate | Experimental | Drug: LP-118LP-118 will be given as tablets of 10mg or 100mg during the induction II course only in combination with ponatinib, dexamethasone, methotrexate and blinatumomab. . Ponatinib, dexamethasone and methotrexate dosing will remain fixed, whereas LP-118 dosing will be dependent on the dose level to which a participant is assigned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ability to understand and willingness to sign an IRB-approved informed consent.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status (PS) ≤ 2.
- Histological or cytological confirmation of newly diagnosed CD19-positive Philadelphia-chromosome/BCR::ABL1-positive ALL.
- Creatinine clearance: ≥60 mL/min, determined by the Cockroft-Gault formula, or measured by a 24-hour urine collection.
Key exclusion criteria (7 listed)
- Any prior treatment for ALL except for a single dose of intrathecal (IT) chemotherapy, corticosteroids, hydroxyurea, a single dose of vincristine, cytarabine, leukapheresis, and/or a BCR::ABL1-targeted tyrosine kinase inhibitor. Permitted prior treatment is limited to a duration of no longer than 14 days. Permitted prior treatment must be stopped at least 24 hours prior to starting study therapy.
- Women who are pregnant, nursing, or who plan to become pregnant while in the study and for at least 6 months after the last administration of all study treatment. NOTE: breast milk cannot be stored for future use while the mother is being treated on study. Pregnant participants are excluded from this study because ponatinib, blinatumomab, and methotrexate have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ponatinib, blinatumomab, and methotrexate breastfeeding should be discontinued if the patient is treated with ponatinib, blinatumomab, and methotrexate.
- Active second malignancy except for localized prostate cancer, basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the skin or cervix.
- Unstable or severe uncontrolled medical condition in the opinion of the enrolling investigator (e.g., unstable cardiac function or unstable pulmonary condition; uncontrolled infection).
- Participants with known history of hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV) are eligible if no evidence of active viral replication by blood testing (i.e. negative viral loads). HIV positive participants must be on active anti-retroviral therapy and willing to continue therapy during study treatment.
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 |
|---|---|---|
| LP-118s LP-118 dosing will be dependent on the dose level to which a participant is assigned: * 50mg PO * 100mg PO * 200mg PO * 300mg PO | Drug | Combination of LP-118, ponatinib, dexamethasone, blinatumomab and methotrexate |
Primary outcome
Estimation of the Maximum Tolerated Dose (MTD) for LP-118 (Dose Escalation)
Time frame: The DLT monitoring period is from Day 1 of Course 2 until the end of Course 2 (approximately 21 days).
Binary variable indicating if a Dose Limiting Toxicity (DLT) occurred.
Identification of the Recommended Phase 2 Dose (RP2D) LP-118 (Dose Expansion)
Time frame: The DLT monitoring period is from Day 1 of Course 2 until the end of Course 2 (approximately 21 days).
Binary variable indicating if a Dose Limiting Toxicity (DLT) occurred.
10 secondary outcomes
Overall Survival (OS).
Time frame: At most 10 years.
Relapsed-Free Survival (RFS).
Time frame: At most 10 years.
Event-Free Survival (EFS).
Time frame: At most 10 years.
Overall Complete Molecular Response (CMR) rate.
Time frame: At most 10 years.
Measurable Residual Disease (MRD) rate.
Time frame: Approximately 3 years.
Isolated Central Nervous System (CNS) relapse rate.
Time frame: At most 10 years.
Complete Response (CR) rate.
Time frame: Approximately 3 years.
Complete clinical remission with incomplete count recovery (CRi)
Time frame: Approximately 3 years.
Overall Response (OR) rate.
Time frame: Approximately 3 years.
Occurrence of toxicities per Common Terminology Criteria V5.0
Time frame: Approximately 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Philadelphia Positive Acute Lymphoblastic Leukemia
Not yet recruiting
Venetoclax Plus Inotuzumab Reduced-Intensity Induction Sequentially Followed by Blinatumomab in B-ALL
ALL
Not yet recruitingPhase 1
BLinatumomab and iNKT in Relapsed B-Cell ALL
B-Cell ALL, ALL (Acute B-Lymphoblastic Leukemia)
RecruitingPhase 1
Asciminib as Maintenance Treatment After Cellular Therapies for Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Not yet recruitingPhase 1
Asciminib-Based Induction Therapy for the Treatment of Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
RecruitingPhase 1/2
Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Philadelphia Chromosome-Positive, Acute Lymphoblastic Leukemia
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.
Madelyn Burkart, MD principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LP-118 in people with Philadelphia Positive Acute Lymphoblastic Leukemia, run by Wake Forest University Health Sciences at 2 sites in United States.
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 12 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dianna Auman, RN (336-716-1122, Dianna.Roesler@Advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the Maximum Tolerated Dose (MTD) for LP-118 (Dose Escalation) (time frame: The DLT monitoring period is from Day 1 of Course 2 until the end of Course 2 (approximately 21 days).). The study lists 2 primary outcomes in all. 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 29 Oct 2026.