Non-Small Cell Lung CancerPhase 1/2NCT05256290
Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations
A Phase 1/2 study testing silevertinib (BDTX-1535) monotherapy in people with Non-Small Cell Lung Cancer and Advanced Non-Small Cell Squamous Lung Cancer, run by Black Diamond Therapeutics, Inc. at 25 sites in United States.
Trial summary
BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of silevertinib (BDTX-1535). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Advanced Non-Small Cell Squamous Lung Cancer, Metastatic Lung Non-Small Cell Carcinoma
- What is being tested?
- silevertinib (BDTX-1535) monotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 25 sitesUnited States
- Study dates
- 31 Mar 2022to Dec 2027
- Phase
- Phase 1/2
- 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
None listed.
Who cannot join
- Known resistant mutations in tumor tissue or by liquid biopsy (eg, T790M, MET).
- Received more than 1 EGFR TKI therapy (ie, erlotinib or gefitinib) for the treatment of metastatic or recurrent EGFR NSCLC.
- Any history of interstitial lung disease related to EGFR TKI use.
- Symptomatic or radiographic leptomeningeal disease.
- Symptomatic brain metastases or spinal cord compression requiring urgent clinical intervention.
- Unresolved toxicity from prior therapy.
Show all 12Show fewer
- Significant cardiovascular disease.
- Major surgery within 4 weeks of study entry or planned during study.
- Ongoing or recent anticancer therapy or radiation therapy.
- Evidence of malignancy (other than study-specific malignancies) requiring active therapy within the next 2 years.
- Active hepatitis B or C infection and/or known human immunodeficiency virus (HIV) carrier.
- Poorly controlled gastrointestinal disorders.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
University of Alabama
Birmingham, Alabama, 35294
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
UNC Hospitals - Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Next Ocology
Fairfax, Virginia, 22031
University of Kansas Cancer Center
Fairway, Kansas, 66205
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
UHP- University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
City of Hope Huntington Beach
Huntington Beach, California, 92648
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
Mayo Clinic- Jacksonville
Jacksonville, Florida, 32224
Cedars Sinai Medical Center
Los Angeles, California, 90048
Miami Cancer Institute - Baptist Health South Florida
Miami, Florida, 33176
Tennessee Oncology
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Columbia University Irving Medical Center
New York, New York, 10032
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Mayo Clinic- Rochester
Rochester, Minnesota, 55905
Fred Hutchinson Cancer Center/University of Washington
Seattle, Washington, 98109
Siteman Cancer Center
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10461
Sibley Memorial Hospital Johns Hopkins Medicine
Washington D.C., District of Columbia, 20016
About this study
Official title: A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients With Glioblastoma or Non-Small Cell Lung Cancer
BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of silevertinib (BDTX-1535). The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma (GBM) expressing EGFR alterations (Phase 1 only). All patients will self-administer silevertinib (BDTX-1535) monotherapy by mouth in 21-day cycles.
Phase 1 enrollment is now complete. Phase 2 is currently ongoing.
- Conditions
- Non-Small Cell Lung Cancer, Advanced Non-Small Cell Squamous Lung Cancer, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Lung Cancer, NSCLC, Advanced Lung Carcinoma
- Being tested
- silevertinib (BDTX-1535) monotherapy
- Keywords
- EGFR alterations, EGFR L858R, EGFR Exon 19 del, EGFR inhibitor, intrinsic resistance NSCLC EGFR, acquired resistance NSCLC EGFR, intracranial disease, brain metastases, central nervous system metastases, CNS metastases, uncommon NSCLC EGFR mutations, C797S acquired resistance EGFR mutation, non-classical NSCLC EGFR mutations, classical NSCLC EGFR mutations, EGFR PACC NSCLC mutations, EGFR E709A/G/K/Q/V, EGFR E709_T710delinsD/T, EGFR G719A/C/D/R/S, EGFR G724S, EGFR L718Q/V
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silevertinib (BDTX-1535) monotherapyDrug
Silevertinib (BDTX-1535) is a 4th generation irreversible brain penetrant EGFR MasterKey inhibitor, which targets a family of oncogenic EGFR classical and non-classical driver and resistance mutations in NSCLC.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Dose Escalation - Monotherapy (Recruitment Closed) | Experimental | * Advanced/metastatic NSCLC with acquired resistance EGFR mutation (eg, C797S), following a 3rd generation EGFR inhibitor in the 1st line setting (in the absence of concurrent T790M).
* Advanced/metastatic NSCLC with non-classical EGFR mutation (eg, G719X) following standard-of-care therapy with an EGFR inhibitor
* Recurrent GBM with confirmed EGFR alterations (including amplification, mutation, and/or variant) Receives: Drug: silevertinib (BDTX-1535) monotherapy |
| Phase 2 Cohort 1: NSCLC EGFR Non-Classical Driver Mutations | Experimental | Advanced/metastatic NSCLC with a non-classical driver EGFR mutation following up to 2 lines of therapy with only 1 prior EGFR targeted regimen (third-generation preferred; other approved EGFR inhibitors acceptable) Receives: Drug: silevertinib (BDTX-1535) monotherapy |
| Phase 2 Cohort 2: NSCLC EGFR Acquired Resistance (C797S) Mutation | Experimental | Advanced/metastatic NSCLC with the acquired resistance C797S EGFR mutation following up to 2 lines of therapy, including only 1 EGFR targeted regimen, which must be a third generation EGFR TKI (eg, osimertinib) Receives: Drug: silevertinib (BDTX-1535) monotherapy |
| Phase 2 Cohort 3: Treatment Naive NSCLC EGFR Non-Classical Driver Mutations | Experimental | Treatment-naïve (first-line) advanced/metastatic NSCLC with a non-classical driver EGFR mutation (1 cycle of chemotherapy or immune checkpoint inhibitor are permitted). Patients with co-occurring L858R mutations and a non-classical mutation are eligible for inclusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Dose Escalation: To determine the maximum tolerated dose (MTD), if one exists, and the preliminary recommended Phase 2 dose(s) (RP2D[s]) of silevertinib (BDTX-1535)
Dose-limiting toxicities (DLTs) in Cycle 1
Measured: The first treatment 21-day cycle (Cycle 1)
Phase 2: To assess antitumor efficacy of silevertinib (BDTX-1535)
Objective response rate (ORR) as assessed by Investigator using RECIST version 1.1
Measured: Day 1 every 2 cycles starting on Cycle 3 Day 1 to study completion, approximately 1 year (each cycle is 21 days)
Secondary outcomes (8)
Phase 1 and Phase 2: Incidence and severity of treatment-emergent adverse events (TEAEs)
Measured: Through study completion, approximately 1 year
Phase 1 and Phase 2: To characterize the plasma concentration of silevertinib (BDTX-1535) following single and multiple dosing
Measured: Cycle 1 Days 1, 2, 15, and 16, Cycles 2 to 5 Day 1, and Day 1 of every other cycle thereafter to study completion, approximately 1 year (each cycle is 21 days)
Phase 1: To assess the preliminary antitumor activity of silevertinib (BDTX-1535) by objective response as assessed by RECIST version 1.1 (for patients with NSCLC) or Response Assessment in Neuro-oncology (RANO) (for patients with GBM)
Measured: Day 1 every 2 cycles starting on Cycle 3 Day 1 to study completion, approximately 1 year (each cycle is 21 days)
Phase 1: To assess the effect of tablet formulation on the plasma concentration of silevertinib (BDTX-1535)
Measured: Two timepoints during the first cycle: Cycle 0 (7 days prior to Cycle 1 Day 1) and Cycle 1 Day 1 only (each cycle is 21 days)
Phase 1: To assess the effect of food on the plasma concentration of silevertinib (BDTX-1535)
Measured: Two timepoints during the first cycle: Cycle 0 (7 days prior to Cycle 1 Day 1) and Cycle 1 Day 1 only (each cycle is 21 days)
Phase 2: To assess duration of tumor response by RECIST version 1.1
Measured: Day 1 every 2 cycles starting at Cycle 3 Day 1 to study completion, approximately 1 year (each cycle is 21 days)
Phase 2: To assess progression free survival by RECIST version 1.1
Measured: Day 1 every 2 cycles starting at Cycle 3 Day 1 to study completion, approximately 1 year (each cycle is 21 days)
Phase 2: To determine the optimal dosage of silevertinib (BDTX-1535) (100 mg or 200 mg daily dose)
Measured: At least the first treatment 21-day cycle (Cycle 1) for select patients enrolled into the Phase 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start31 Mar 2022
- Primary completion3 Nov 2025
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Black Diamond Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Black Diamond Therapeutics, Study director, Black Diamond Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256290
- Sponsor's protocol ID
- BDTX-1535-101
- Status last verified
- Jul 2026
- First submitted
- 15 Feb 2022
- Last updated
- 22 Jul 2026
- Results posted
- No
- 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients With Glioblastoma or Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05256290
- Acronym / sponsor ID
- BDTX-1535-101
- Conditions
- Non-Small Cell Lung Cancer, Advanced Non-Small Cell Squamous Lung Cancer, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Lung Cancer, NSCLC, Advanced Lung Carcinoma
- Keywords
- EGFR alterations, EGFR L858R, EGFR Exon 19 del, EGFR inhibitor, intrinsic resistance NSCLC EGFR, acquired resistance NSCLC EGFR, intracranial disease, brain metastases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Black Diamond Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Feb 2022 (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.
BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of silevertinib (BDTX-1535). The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma (GBM) expressing EGFR alterations (Phase 1 only). All patients will self-administer silevertinib (BDTX-1535) monotherapy by mouth in 21-day cycles.
Phase 1 enrollment is now complete. Phase 2 is currently ongoing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Dose Escalation - Monotherapy (Recruitment Closed) | Experimental | Drug: silevertinib (BDTX-1535) monotherapy* Advanced/metastatic NSCLC with acquired resistance EGFR mutation (eg, C797S), following a 3rd generation EGFR inhibitor in the 1st line setting (in the absence of concurrent T790M). * Advanced/metastatic NSCLC with non-classical EGFR mutation (eg, G719X) following standard-of-care therapy with an EGFR inhibitor * Recurrent GBM with confirmed EGFR alterations (including amplification, mutation, and/or variant) |
| Phase 2 Cohort 1: NSCLC EGFR Non-Classical Driver Mutations | Experimental | Drug: silevertinib (BDTX-1535) monotherapyAdvanced/metastatic NSCLC with a non-classical driver EGFR mutation following up to 2 lines of therapy with only 1 prior EGFR targeted regimen (third-generation preferred; other approved EGFR inhibitors acceptable) |
| Phase 2 Cohort 2: NSCLC EGFR Acquired Resistance (C797S) Mutation | Experimental | Drug: silevertinib (BDTX-1535) monotherapyAdvanced/metastatic NSCLC with the acquired resistance C797S EGFR mutation following up to 2 lines of therapy, including only 1 EGFR targeted regimen, which must be a third generation EGFR TKI (eg, osimertinib) |
| Phase 2 Cohort 3: Treatment Naive NSCLC EGFR Non-Classical Driver Mutations | Experimental | –Treatment-naïve (first-line) advanced/metastatic NSCLC with a non-classical driver EGFR mutation (1 cycle of chemotherapy or immune checkpoint inhibitor are permitted). Patients with co-occurring L858R mutations and a non-classical mutation are eligible for inclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Known resistant mutations in tumor tissue or by liquid biopsy (eg, T790M, MET).
- Received more than 1 EGFR TKI therapy (ie, erlotinib or gefitinib) for the treatment of metastatic or recurrent EGFR NSCLC.
- Any history of interstitial lung disease related to EGFR TKI use.
- Symptomatic or radiographic leptomeningeal disease.
- Symptomatic brain metastases or spinal cord compression requiring urgent clinical intervention.
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 |
|---|---|---|
| silevertinib (BDTX-1535) monotherapySilevertinib (BDTX-1535) is a 4th generation irreversible brain penetrant EGFR MasterKey inhibitor, which targets a family of oncogenic EGFR classical and non-classical driver and resistance mutations in NSCLC. | Drug | Phase 1 Dose Escalation - Monotherapy (Recruitment Closed), Phase 2 Cohort 1: NSCLC EGFR Non-Classical Driver Mutations, Phase 2 Cohort 2: NSCLC EGFR Acquired Resistance (C797S) Mutation |
Primary outcome
Phase 1 Dose Escalation: To determine the maximum tolerated dose (MTD), if one exists, and the preliminary recommended Phase 2 dose(s) (RP2D[s]) of silevertinib (BDTX-1535)
Time frame: The first treatment 21-day cycle (Cycle 1)
Dose-limiting toxicities (DLTs) in Cycle 1
Phase 2: To assess antitumor efficacy of silevertinib (BDTX-1535)
Time frame: Day 1 every 2 cycles starting on Cycle 3 Day 1 to study completion, approximately 1 year (each cycle is 21 days)
Objective response rate (ORR) as assessed by Investigator using RECIST version 1.1
8 secondary outcomes
Phase 1 and Phase 2: Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: Through study completion, approximately 1 year
Phase 1 and Phase 2: To characterize the plasma concentration of silevertinib (BDTX-1535) following single and multiple dosing
Time frame: Cycle 1 Days 1, 2, 15, and 16, Cycles 2 to 5 Day 1, and Day 1 of every other cycle thereafter to study completion, approximately 1 year (each cycle is 21 days)
Phase 1: To assess the preliminary antitumor activity of silevertinib (BDTX-1535) by objective response as assessed by RECIST version 1.1 (for patients with NSCLC) or Response Assessment in Neuro-oncology (RANO) (for patients with GBM)
Time frame: Day 1 every 2 cycles starting on Cycle 3 Day 1 to study completion, approximately 1 year (each cycle is 21 days)
Phase 1: To assess the effect of tablet formulation on the plasma concentration of silevertinib (BDTX-1535)
Time frame: Two timepoints during the first cycle: Cycle 0 (7 days prior to Cycle 1 Day 1) and Cycle 1 Day 1 only (each cycle is 21 days)
Phase 1: To assess the effect of food on the plasma concentration of silevertinib (BDTX-1535)
Time frame: Two timepoints during the first cycle: Cycle 0 (7 days prior to Cycle 1 Day 1) and Cycle 1 Day 1 only (each cycle is 21 days)
Phase 2: To assess duration of tumor response by RECIST version 1.1
Time frame: Day 1 every 2 cycles starting at Cycle 3 Day 1 to study completion, approximately 1 year (each cycle is 21 days)
Phase 2: To assess progression free survival by RECIST version 1.1
Time frame: Day 1 every 2 cycles starting at Cycle 3 Day 1 to study completion, approximately 1 year (each cycle is 21 days)
Phase 2: To determine the optimal dosage of silevertinib (BDTX-1535) (100 mg or 200 mg daily dose)
Time frame: At least the first treatment 21-day cycle (Cycle 1) for select patients enrolled into the Phase 2
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 22 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Non-Small Cell Lung Cancer
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
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Black Diamond Therapeutics study director
Black Diamond Therapeutics
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing silevertinib (BDTX-1535) monotherapy in people with Non-Small Cell Lung Cancer and Advanced Non-Small Cell Squamous Lung Cancer, run by Black Diamond Therapeutics, Inc. at 25 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 0 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 combined 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.
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?
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?
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?
Phase 1 Dose Escalation: To determine the maximum tolerated dose (MTD), if one exists, and the preliminary recommended Phase 2 dose(s) (RP2D[s]) of silevertinib (BDTX-1535) (time frame: The first treatment 21-day cycle (Cycle 1)). 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 22 Jul 2026.