Breast CarcinomaPhase 2/3AIPAC-003NCT05747794
Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination With Paclitaxel Chemotherapy
A Phase 2/3 study testing eftilagimod alpha and Paclitaxel in people with Breast Carcinoma, run by Immutep S.A.S. at 22 sites in 5 countries.
Trial summary
The goal of this clinical trial is to compare the safety and efficacy of eftilagimod alpha (efti) in combination with paclitaxel standard of care chemotherapy in participants with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- eftilagimod alpha and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 22 May 2023to 30 Jun 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic HR+ positive (estrogen receptor positive and/or progesterone receptor positive) or hormone receptor negative (HR˗), and HER2-neg breast adenocarcinoma, histologically proven by biopsy on the last available tumor tissue
- Participants with HR+ metastatic breast cancer (MBC) who progressed on or after ≥1 line of endocrine based therapy and are indicated to receive chemotherapy for metastatic disease
- Participants with HR- MBC (i.e. triple-negative breast cancer [TNBC]) who are indicated to receive paclitaxel chemotherapy without PD 1/PD-L1 therapy in the 1st line setting for metastatic disease
- ECOG performance status 0-1
- Expected survival longer than three months
Who cannot join
- Prior chemotherapy for metastatic breast adenocarcinoma
- Participants with HR+ MBC who have received <1 line of ET based therapy in the metastatic setting
- Participants with HR+ MBC who are not primary or secondary resistant to ET-based therapy and would be candidates to ET based therapy as per applicable treatment guidelines
- TNBC participants who are candidates for PD-1/PD-L1 therapy in combination with chemotherapy
- Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
Spain9 sites
Institut Català d'Oncologia
Badalona, 08916
VHIO - Hospital Vall d'Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Parc Taulí Hospital Universitari
Barcelona, 08208
Hospital Universitario Reina Sofia
Córdoba, 14004
Hospital Universitario de Jaén
Jaén, 23007
Unidad Ensayos Clínicos Oncología Fundació IRB Lleida
Lleida, 25196
START Madrid - FJD, Hospital Fundación Jiménez Diaz
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Belgium6 sites
AZ Sint-Jan Brugge Oostende av
Bruges
Cliniques Universitaires Saint-Luc
Brussels, 1200
Grand Hopital de Charleroi - Hopital Notre Dame
Charleroi, 6000
Universitair Ziekenhuizen Antwerpen
Edegem, 2650
Centre Hospitalier de l'Ardenne
Libramont, 6800
Clinique Saint-Pierre- Ottignies
Ottignies-Louvain-la-Neuve
United States5 sites
Oncology Consultants
Houston, Texas, 77024
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, 29723
The George Washington University Cancer Center
Washington D.C., District of Columbia, 20037
The Oncology Institute
Whittier, California, 90602
About this study
Official title: AIPAC-003 (Active Immunotherapy and PAClitaxel): A Randomized, Double-blind, Placebo-controlled Phase 3 Trial Testing Eftilagimod Alpha (Soluble LAG-3) in HER2-neg/Low Metastatic Breast Cancer Patients Receiving Paclitaxel, Following an Open-label Dose Optimization
The goal of this clinical trial is to compare the safety and efficacy of eftilagimod alpha (efti) in combination with paclitaxel standard of care chemotherapy in participants with metastatic breast cancer.
The main questions it aims to answer are:
Read more
- What is the optimal biological dose (OBD) of efti in combination with weekly paclitaxel chemotherapy?
- Can efti combined with weekly paclitaxel chemotherapy prolong overall survival in participants with metastatic breast cancer if compared to weekly paclitaxel chemotherapy alone?
In the first component of the trial (phase 2, lead-in) researchers will compare two groups (different dose levels of efti in combination with standard chemotherapy) to see if the treatment is safe and well tolerated and evaluate which is the optimal biological dose. In the second component of the trial (phase 3) researchers will assess if the treatment of metastatic breast cancer with the optimal biological dose of efti in combination with paclitaxel is superior compared to chemotherapy alone (placebo-controlled).
The treatment concept of each trial component consists of a chemo-immunotherapy phase followed by an immunotherapy phase. In the first phase participants will be treated with efti plus paclitaxel chemotherapy or placebo plus paclitaxel chemotherapy. After completion of the chemotherapy per standard of care, participants will be treated with the study agent alone.
Read the detailed description
The AIPAC-003 trial consists of an open-label dose optimization lead-in component followed by a double-blinded, randomized, placebo-controlled phase 3 component.
The main objectives of the dose optimization lead-in (phase 2) are to evaluate and compare the safety and tolerability of 2 different dose levels of efti (30 mg and 90 mg) combined with paclitaxel, and to define the optimal biological dose (OBD) of efti in combination with weekly paclitaxel for the phase 3 part of the trial. Recruitment to the dose-optimization lead-in will be considered complete when 29 participants per cohort are randomized and considered evaluable for OBD analysis.
The main objective of the phase 3 is to demonstrate that overall survival (OS) is superior in participants treated with efti combined with weekly paclitaxel compared to weekly paclitaxel plus placebo. Approximately 771 participants will be randomized 2:1 to Arm A (active arm): paclitaxel + efti at OBD and Arm B (control arm): paclitaxel + placebo. The exact patient population will be defined after determination of the OBD.
The duration of the trial will be approximately 24 months for the dose optimization lead-in component and 60 months for the phase 3 component. The phase 3 will start prior to the completion of the phase 2 (once the OBD has been defined).
It is planned to conduct the trial at up to 20 sites in up to 4 countries across North America and Europe for the lead-in and at up to 150 sites in up to 25 countries across North America, Europe, Latin America and the Asian Pacific region for the phase 3.
- Conditions
- Breast Carcinoma
- Being tested
- eftilagimod alpha, Paclitaxel, placebo
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eftilagimod alphaBiological
Also called IMP321, efti, LAG-3Ig, eftilagimod alfa
APC activator, MHC II agonist
PaclitaxelDrug
paclitaxel will be given as standard of care (chemotherapy)
placeboOther
Also called placebo matching eftilagimod alpha
placebo matching eftilagimod alpha
| Study group | Role | What they receive |
|---|---|---|
| open label lead-in (phase 2): eftilagimod alpha 30mg + paclitaxel | Experimental | eftilagimod alpha 30mg s.c. + 80mg/m^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned. Receives: Biological: eftilagimod alpha; Drug: Paclitaxel |
| open label lead-in (phase 2): eftilagimod alpha 90mg + paclitaxel | Experimental | eftilagimod alpha 90mg s.c. + 80mg/m^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned. Receives: Biological: eftilagimod alpha; Drug: Paclitaxel |
| Phase 3: eftilagimod alpha + paclitaxel | Experimental | eftilagimod alpha s.c. (OBD) + 80mg/m^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned. Receives: Biological: eftilagimod alpha; Drug: Paclitaxel |
| Phase 3: placebo + paclitaxel | Placebo comparator | placebo s.c. + 80mg/m^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned. Receives: Drug: Paclitaxel; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Overall survival (OS)
Primary endpoint for Phase 3 portion, secondary endpoint for Phase 2 lead-in portion
Measured: Until trial end, death, withdrawal of consent or lost to follow-up, assessed up to 60 months
Determination of the Optimal Biological Dose (OBD)
Measured: Up to 15 months
Frequency of adverse events (AEs)
Measured: Up to 15 months
Severity of adverse events (AEs)
Measured: Up to 15 months
Duration of adverse events (AEs)
Measured: Up to 15 months
Occurrence of dose-limiting toxicities (DLTs)
Measured: Up to 15 months
Secondary outcomes (2)
Determination of Progression Free Survival (PFS), based on RECIST, v1.1
Measured: Until occurrence of progressive disease, or the start of any further next line anticancer treatment, or until the end of the trial for any other reason, assessed up to 60 months
Evaluation of Objective Response Rate (ORR) based on RECIST v1.1
Measured: Until occurrence of progressive disease, or the start of any further next line anticancer treatment, or until the end of the trial for any other reason, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start22 May 2023
- Primary completion30 Apr 2026
- Study completion30 Jun 2026
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial consists of an open-label dose optimization lead-in component (phase 2) followed by a double-blinded, randomized, placebo-controlled phase 3 component.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immutep S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747794
- Sponsor's protocol ID
- AIPAC-003
- Other IDs
- 2022-003323-17, 2024-511023-34-00
- Acronym
- AIPAC-003
- Status last verified
- Jul 2026
- First submitted
- 2 Feb 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIPAC-003 (Active Immunotherapy and PAClitaxel): A Randomized, Double-blind, Placebo-controlled Phase 3 Trial Testing Eftilagimod Alpha (Soluble LAG-3) in HER2-neg/Low Metastatic Breast Cancer Patients Receiving Paclitaxel, Following an Open-label Dose Optimization
- ClinicalTrials.gov ID
- NCT05747794
- Acronym / sponsor ID
- AIPAC-003 / AIPAC-003
- Conditions
- Breast Carcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Immutep S.A.S.Industry (pharma, biotech, devices)
- Study start
- 22 May 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 28 Feb 2023 (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 goal of this clinical trial is to compare the safety and efficacy of eftilagimod alpha (efti) in combination with paclitaxel standard of care chemotherapy in participants with metastatic breast cancer.
The main questions it aims to answer are:
- What is the optimal biological dose (OBD) of efti in combination with weekly paclitaxel chemotherapy?
- Can efti combined with weekly paclitaxel chemotherapy prolong overall survival in participants with metastatic breast cancer if compared to weekly paclitaxel chemotherapy alone?
In the first component of the trial (phase 2, lead-in) researchers will compare two groups (different dose levels of efti in combination with standard chemotherapy) to see if the treatment is safe and well tolerated and evaluate which is the optimal biological dose. In the second component of the trial (phase 3) researchers will assess if the treatment of metastatic breast cancer with the optimal biological dose of efti in combination with paclitaxel is superior compared to chemotherapy alone (placebo-controlled).
The treatment concept of each trial component consists of a chemo-immunotherapy phase followed by an immunotherapy phase. In the first phase participants will be treated with efti plus paclitaxel chemotherapy or placebo plus paclitaxel chemotherapy. After completion of the chemotherapy per standard of care, participants will be treated with the study agent alone.
Detailed description
The AIPAC-003 trial consists of an open-label dose optimization lead-in component followed by a double-blinded, randomized, placebo-controlled phase 3 component.
The main objectives of the dose optimization lead-in (phase 2) are to evaluate and compare the safety and tolerability of 2 different dose levels of efti (30 mg and 90 mg) combined with paclitaxel, and to define the optimal biological dose (OBD) of efti in combination with weekly paclitaxel for the phase 3 part of the trial. Recruitment to the dose-optimization lead-in will be considered complete when 29 participants per cohort are randomized and considered evaluable for OBD analysis.
The main objective of the phase 3 is to demonstrate that overall survival (OS) is superior in participants treated with efti combined with weekly paclitaxel compared to weekly paclitaxel plus placebo. Approximately 771 participants will be randomized 2:1 to Arm A (active arm): paclitaxel + efti at OBD and Arm B (control arm): paclitaxel + placebo. The exact patient population will be defined after determination of the OBD.
The duration of the trial will be approximately 24 months for the dose optimization lead-in component and 60 months for the phase 3 component. The phase 3 will start prior to the completion of the phase 2 (once the OBD has been defined).
It is planned to conduct the trial at up to 20 sites in up to 4 countries across North America and Europe for the lead-in and at up to 150 sites in up to 25 countries across North America, Europe, Latin America and the Asian Pacific region for the phase 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- This trial consists of an open-label dose optimization lead-in component (phase 2) followed by a double-blinded, randomized, placebo-controlled phase 3 component.
| Arm | Type | Receives |
|---|---|---|
| open label lead-in (phase 2): eftilagimod alpha 30mg + paclitaxel | Experimental | Biological: eftilagimod alpha, Drug: Paclitaxeleftilagimod alpha 30mg s.c. + 80mg/m^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned. |
| open label lead-in (phase 2): eftilagimod alpha 90mg + paclitaxel | Experimental | Biological: eftilagimod alpha, Drug: Paclitaxeleftilagimod alpha 90mg s.c. + 80mg/m^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned. |
| Phase 3: eftilagimod alpha + paclitaxel | Experimental | Biological: eftilagimod alpha, Drug: Paclitaxeleftilagimod alpha s.c. (OBD) + 80mg/m^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned. |
| Phase 3: placebo + paclitaxel | Placebo comparator | Drug: Paclitaxel, Other: placeboplacebo s.c. + 80mg/m^2 paclitaxel i.v. (same-day administration): The trial consists of a chemo-immunotherapy (chemo-IO) phase followed by an immunotherapy (IO)-phase. The chemo-IO phase consists of a planned 6 cycles of 4 weeks (28 days each) that may be longer or shorter depending on chemo tolerance. The IO-phase is planned to follow the chemo-IO phase. A maximum of 13 cycles (approx. 12 months) of treatment is planned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Metastatic HR+ positive (estrogen receptor positive and/or progesterone receptor positive) or hormone receptor negative (HR˗), and HER2-neg breast adenocarcinoma, histologically proven by biopsy on the last available tumor tissue
- Participants with HR+ metastatic breast cancer (MBC) who progressed on or after ≥1 line of endocrine based therapy and are indicated to receive chemotherapy for metastatic disease
- Participants with HR- MBC (i.e. triple-negative breast cancer [TNBC]) who are indicated to receive paclitaxel chemotherapy without PD 1/PD-L1 therapy in the 1st line setting for metastatic disease
- ECOG performance status 0-1
- Expected survival longer than three months
Key exclusion criteria (5 listed)
- Prior chemotherapy for metastatic breast adenocarcinoma
- Participants with HR+ MBC who have received <1 line of ET based therapy in the metastatic setting
- Participants with HR+ MBC who are not primary or secondary resistant to ET-based therapy and would be candidates to ET based therapy as per applicable treatment guidelines
- TNBC participants who are candidates for PD-1/PD-L1 therapy in combination with chemotherapy
- Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy
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 |
|---|---|---|
| eftilagimod alphaAlso: IMP321, efti, LAG-3Ig, eftilagimod alfaAPC activator, MHC II agonist | Biological | Phase 3: eftilagimod alpha + paclitaxel, open label lead-in (phase 2): eftilagimod alpha 30mg + paclitaxel, open label lead-in (phase 2): eftilagimod alpha 90mg + paclitaxel |
| Paclitaxelpaclitaxel will be given as standard of care (chemotherapy) | Drug | Phase 3: eftilagimod alpha + paclitaxel, Phase 3: placebo + paclitaxel, open label lead-in (phase 2): eftilagimod alpha 30mg + paclitaxel, open label lead-in (phase 2): eftilagimod alpha 90mg + paclitaxel |
| placeboAlso: placebo matching eftilagimod alphaplacebo matching eftilagimod alpha | Other | Phase 3: placebo + paclitaxel |
Primary outcome
Determination of Overall survival (OS)
Time frame: Until trial end, death, withdrawal of consent or lost to follow-up, assessed up to 60 months
Primary endpoint for Phase 3 portion, secondary endpoint for Phase 2 lead-in portion
Determination of the Optimal Biological Dose (OBD)
Time frame: Up to 15 months
Frequency of adverse events (AEs)
Time frame: Up to 15 months
Severity of adverse events (AEs)
Time frame: Up to 15 months
Duration of adverse events (AEs)
Time frame: Up to 15 months
Occurrence of dose-limiting toxicities (DLTs)
Time frame: Up to 15 months
2 secondary outcomes
Determination of Progression Free Survival (PFS), based on RECIST, v1.1
Time frame: Until occurrence of progressive disease, or the start of any further next line anticancer treatment, or until the end of the trial for any other reason, assessed up to 60 months
Evaluation of Objective Response Rate (ORR) based on RECIST v1.1
Time frame: Until occurrence of progressive disease, or the start of any further next line anticancer treatment, or until the end of the trial for any other reason, assessed up to 60 months
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing eftilagimod alpha and Paclitaxel in people with Breast Carcinoma, run by Immutep S.A.S. at 22 sites in 5 countries.
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 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 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 22 sites in Spain, Belgium, United States, Georgia, Moldova. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Overall survival (OS) (time frame: Until trial end, death, withdrawal of consent or lost to follow-up, assessed up to 60 months). The study lists 6 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 30 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.