Treatment of Recurrent Ovarian CancerPhase 2NCT07286240
QL1706 Combined With Chemotherapy and Anlotinib for the Treatment of Recurrent Ovarian Cancer
A Phase 2 study testing QL1706 plus chemotherapy and anlotinib regimen in people with Treatment of Recurrent Ovarian Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.
Trial summary
Ovarian cancer is one of the most common gynecologic malignancies, with considerable histologic heterogeneity; more than 90 % of cases are epithelial ovarian cancers. Because no reliable tools exist for early detection, approximately 70 % of patients are diagnosed at an advanced stage and have poor prognosis, and >70… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Treatment of Recurrent Ovarian Cancer
- What is being tested?
- QL1706 plus chemotherapy and anlotinib regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2025to 30 Mar 2028
- Phase
- Phase 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Capable of understanding and voluntarily signing the written Informed Consent Form (ICF); the ICF must be signed before any study-specific procedures are performed.
- 2.Female, aged 18-70 years at the time of ICF signature. 3.Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 4.Life expectancy ≥ 3 months. 5.Histologically confirmed epithelial ovarian cancer (including fallopian-tube and primary peritoneal carcinoma) that has recurred after standard platinum-based therapy:
- Platinum-sensitive relapse (recurrence ≥ 6 months after completion of the last platinum-based therapy).
- Platinum-resistant relapse (recurrence < 6 months after completion of the last platinum-based therapy or progression while on PARP-inhibitor maintenance).
- Note: Maintenance PARP inhibitor or bevacizumab after CR/PR to prior chemotherapy, and hormonal therapy, are not counted as additional lines of therapy.
- 6.At least one measurable lesion per RECIST v1.1. Lesions previously irradiated or treated with other loco-regional therapy can serve only as non-target lesions unless clear progression is documented or tumor viability is biopsy-proven.
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- 7.Archived or freshly obtained tumor tissue (primary or relapse) must be available for biomarker analyses. Five unstained formalin-fixed paraffin-embedded (FFPE) slides or a tissue block are required for central PD-L1 testing (slides preferred). If re-biopsy is judged unsafe, the number of slides may be reduced after discussion with the medical monitor.
- 8.Adequate organ function at screening:
- Hematology:
- Hb ≥ 90 g/L ANC ≥ 1.5 × 10⁹/L PLT ≥ 100 × 10⁹/L
- Biochemistry:
- Albumin ≥ 29 g/L ALT/AST < 3 × ULN (< 5 × ULN if liver metastases) TBIL ≤ 1.5 × ULN Creatinine ≤ 1.5 × ULN 9.Women of child-bearing potential must have a negative serum pregnancy test within 3 days before first dose. If sexually active with a non-sterilized male partner, they must use a highly effective contraceptive method from screening until 6 months after the last study-dose; rhythm or withdrawal methods are not acceptable.
- 10.The need for additional cytoreductive surgery is at the investigator's discretion.
Who cannot join
- 1.Non-epithelial ovarian malignancies (e.g., carcinosarcoma, sex-cord stromal tumors).
- 2.Central-nervous-system metastases or meningeal carcinomatosis. 3.Pleural, pericardial, or ascitic effusions requiring repeat drainage > once per month.
- 4.Active malignancy within 3 years before first dose, except locally curable cancers deemed cured (e.g., squamous- or basal-cell skin cancer, superficial bladder cancer, ductal carcinoma in situ of breast).
- 5.Prior systemic anti-cancer therapy within 3 weeks (chemotherapy, bevacizumab/biosimilars, TKI, PARP inhibitor); palliative radiotherapy or immunomodulators (e.g., thymosin, interferon, IL-2) or cancer-treating Chinese patent medicines (e.g., Aidi injection) within 2 weeks; hormonal agents (e.g., tamoxifen, letrozole) within 1 week.
- 6.Previous immune-checkpoint inhibitors (anti-PD-1, anti-PD-L1, anti-CTLA-4, etc.) or agonists of immune co-stimulatory molecules (ICOS, CD40, CD137, GITR, OX40, etc.).
- 7.Major surgery, open biopsy, or significant trauma within 4 weeks; elective major surgery planned during study.
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- 8.Active or likely recurrent autoimmune disease (exceptions: vitiligo, alopecia, psoriasis/eczema not requiring systemic therapy; hypothyroidism from autoimmune thyroiditis on stable replacement; type 1 diabetes on stable insulin).
- 9.Systemic corticosteroids > 10 mg/day prednisone equivalent or other immunosuppressants within 14 days (inhaled, ophthalmic, or topical steroids ≤ 10 mg/day permitted).
- 10.Live vaccine within 4 weeks. 11.Primary or secondary immunodeficiency, including positive HIV antibody. 12.Prior solid-organ or allogeneic hematopoietic-stem-cell transplant. 13.History of interstitial lung disease or non-infectious pneumonitis. 14.Severe infection within 4 weeks (complicated infection requiring hospitalization, sepsis, severe pneumonia).
- 15.Active infection requiring systemic therapy (including active TB or active syphilis) or systemic antibiotics/antivirals/antifungals within 2 weeks (except suppressive anti-HBV therapy).
- 16.Active hepatitis B (HBsAg-positive with HBV DNA > 1000 IU/mL); active hepatitis C. Inactive HBV carriers with HBV DNA ≤ 1000 IU/mL are eligible. Subjects with cured HCV (HCV Ab-positive and HCV RNA-negative) are eligible.
- 17.Inflammatory bowel disease (Crohn's, ulcerative colitis), active diverticulitis, clinical bowel obstruction, or need for parenteral hydration/nutrition or nasogastric tube.
- 18.Significant cardiovascular/cerebrovascular disease:
- MI, unstable angina, pulmonary embolism, aortic dissection, DVT, arterial thrombo-embolism within 6 months
- NYHA class ≥ II heart failure
- Serious arrhythmia requiring chronic therapy (stable-rate asymptomatic atrial fibrillation allowed)
- CVA within 6 months
- LVEF < 50 %
- Prior myocarditis/cardiomyopathy; uncontrolled hypertension (> 150/100 mmHg) or hypertensive crisis/encephalopathy 19.Peripheral neuropathy ≥ grade 2 (NCI CTCAE v5.0). 20.Unresolved toxicity > grade 1 from prior anti-cancer therapy (except alopecia).
- 21.Severe hypersensitivity to any monoclonal antibody. 22.Pregnancy or lactation. 23.Any condition that, in the investigator's opinion, would compromise safety, interfere with study evaluations, or confound results (e.g., severe concomitant disease or psychiatric disorder).
- 24.Known hypersensitivity to any study drug or excipient. 25.Prior gastrointestinal perforation, intra-abdominal abscess, or bowel obstruction within 3 months or radiologic/clinical evidence of obstruction.
- 26.Hypertension inadequately controlled on medication (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg).
- 27.Coagulopathy (INR > 2.0 or PT > 16 s), bleeding diathesis, or thrombolytic/anticoagulant therapy (prophylactic low-dose aspirin or LMWH allowed).
- 28.Clinically significant bleeding or bleeding tendency within 3 months (e.g., GI bleeding, hemorrhagic gastritis, vasculitis).
- 29.Arterial or venous thrombosis within 6 months (CVA, TIA, intracranial bleed, DVT, PE); superficial vein thrombosis may be allowed at investigator's discretion.
- 30.Hereditary or acquired bleeding/thrombotic disorders (e.g., hemophilia, coagulation defects, thrombocytopenia).
- 31.Active ulcer, non-healing wound, or fracture. 32.Urine protein ≥ ++ confirmed by 24-h urine protein > 1.0 g. 33.Prior palliative radiotherapy to > 5 % of bone-marrow area within 4 weeks. 34.Strong CYP3A4 inducers within 2 weeks or strong CYP3A4 inhibitors within 1 week.
- 35.Prior treatment with anlotinib or other small-molecule multi-target TKIs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Lipai Chen
Guangzhou, Guangdong
chen lipai, 13556170919, chenlipai@163.com
About this study
Official title: A Single-arm, Multicenter Phase II Clinical Study of QL1706 Combined With Chemotherapy and Anlotinib for the Treatment of Recurrent Ovarian Cancer
Ovarian cancer is one of the most common gynecologic malignancies, with considerable histologic heterogeneity; more than 90 % of cases are epithelial ovarian cancers. Because no reliable tools exist for early detection, approximately 70 % of patients are diagnosed at an advanced stage and have poor prognosis, and >70 % experience relapse within 3 years of initial treatment. The standard first-line strategy combines cytoreductive surgery, platinum-based chemotherapy, and maintenance with PARP inhibitors. Management of recurrent disease remains one of the most challenging problems in clinical oncology.
Bevacizumab, a recombinant humanized anti-VEGF monoclonal antibody that blocks endothelial proliferation and neovascularization, is the prototypic angiogenesis inhibitor used in ovarian cancer. However, randomized trials have demonstrated only progression-free survival (PFS) benefit, with no overall survival (OS) advantage. Pre-clinical data suggest that immunotherapy and anti-angiogenic agents can exert synergistic anti-tumor activity, yet clinical efforts combining bevacizumab with immune-checkpoint inhibitors in recurrent ovarian cancer-whether added to platinum-based chemotherapy, used as maintenance, or evaluated in chemotherapy-free regimens-have thus far been unsuccessful (except in clear-cell histology).
Read more
Anlotinib is a novel oral multi-target tyrosine-kinase inhibitor that blocks VEGFR-2/3, FGFR 1-4, PDGFR-α/β, c-KIT, and RET, thereby potently suppressing angiogenesis. Accumulating evidence indicates that anlotinib plus chemotherapy is more effective than chemotherapy alone in advanced or recurrent ovarian cancer, with a manageable safety profile, showing encouraging efficacy and tolerability.
Because conventional approaches for recurrent ovarian cancer are limited-particularly once platinum resistance develops-new therapeutic strategies are urgently needed. The best-characterized immune-checkpoint molecules are CTLA-4 and the PD-1/PD-L1 axis. Combined blockade of CTLA-4 and PD-1 has yielded impressive activity in several tumor types. Although single-agent checkpoint inhibitors produce modest response rates in recurrent ovarian cancer, preliminary data suggest that dual inhibition with anti-CTLA-4 plus anti-PD-1 antibodies may enhance therapeutic responses.QL1706 is a novel dual-target immunotherapeutic agent that has been approved for second-line monotherapy in cervical cancer.QL1706, developed by Qilu Pharmaceutical using the proprietary MabPair™ platform, is the first bispecific antibody simultaneously targeting PD-1 and CTLA-4, showing synergistic anti-tumor activity and favorable tolerability.The treatment of recurrent ovarian cancer remains a formidable challenge; therefore, proactive exploration of diverse combination regimens is essential to achieve optimal therapeutic efficacy and maximize survival benefit for patients.
- Conditions
- Treatment of Recurrent Ovarian Cancer
- Being tested
- QL1706 plus chemotherapy and anlotinib regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706 plus chemotherapy and anlotinib regimenDrug
QL1706 (5 mg/kg) IV d1, q3w Pegylated liposomal doxorubicin hydrochloride (30 mg/m²) IV d1, q3w Carboplatin (AUC = 5) IV d1, q3w -OR- cisplatin (75 mg/m²) IV d1, q3w Anlotinib: 8 mg PO qd d1-14, q3w Administer for 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| QL1706 plus chemotherapy and anlotinib regimen | Experimental | Not described Receives: Drug: QL1706 plus chemotherapy and anlotinib regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The ratio of patients who are evaluated as CR or PR
Measured: 2 years
PFS
PFS: defined as the time from the date of first dose to the first documented progressive disease (PD) or death from any cause, whichever occurs first, within the tumor-assessment follow-up period.
Measured: 2 years
Secondary outcomes (5)
DCR
DCR: the proportion of patients with best overall response of complete response (CR), partial response (PR), or stable disease (SD) for ≥4 weeks.
Measured: 2 years
OS
OS: defined as the time from the date of first dose to death from any cause (for patients lost to follow-up before death, the date of last known contact is conventionally used as the date of death).
Measured: 2 years
DOR
DOR: In patients who achieve an objective response, DOR is defined as the time from the first documented complete response (CR) or partial response (PR) (whichever occurs first) to the date of progressive disease (PD) or death from any cause (whichever occurs first).
Measured: 2 years
TTR
TTR (Time to Response): For patients who achieve an objective response, TTR is defined as the time from the date of first dose to the first documented complete response (CR) or partial response (PR), whichever occurs first.
Measured: 2 years
CA125 response
CA125 response: assessed according to the GCIG (Gynecologic Cancer InterGroup) criteria.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start15 Nov 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Recurrent Ovarian 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lipai Chen, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286240
- Sponsor's protocol ID
- QL-0ca-QIBA-3003
- Status last verified
- Sep 2025
- First submitted
- 3 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter Phase II Clinical Study of QL1706 Combined With Chemotherapy and Anlotinib for the Treatment of Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07286240
- Acronym / sponsor ID
- QL-0ca-QIBA-3003
- Conditions
- Treatment of Recurrent Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 16 Dec 2025 (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.
Ovarian cancer is one of the most common gynecologic malignancies, with considerable histologic heterogeneity; more than 90 % of cases are epithelial ovarian cancers. Because no reliable tools exist for early detection, approximately 70 % of patients are diagnosed at an advanced stage and have poor prognosis, and >70 % experience relapse within 3 years of initial treatment. The standard first-line strategy combines cytoreductive surgery, platinum-based chemotherapy, and maintenance with PARP inhibitors. Management of recurrent disease remains one of the most challenging problems in clinical oncology.
Bevacizumab, a recombinant humanized anti-VEGF monoclonal antibody that blocks endothelial proliferation and neovascularization, is the prototypic angiogenesis inhibitor used in ovarian cancer. However, randomized trials have demonstrated only progression-free survival (PFS) benefit, with no overall survival (OS) advantage. Pre-clinical data suggest that immunotherapy and anti-angiogenic agents can exert synergistic anti-tumor activity, yet clinical efforts combining bevacizumab with immune-checkpoint inhibitors in recurrent ovarian cancer-whether added to platinum-based chemotherapy, used as maintenance, or evaluated in chemotherapy-free regimens-have thus far been unsuccessful (except in clear-cell histology).
Anlotinib is a novel oral multi-target tyrosine-kinase inhibitor that blocks VEGFR-2/3, FGFR 1-4, PDGFR-α/β, c-KIT, and RET, thereby potently suppressing angiogenesis. Accumulating evidence indicates that anlotinib plus chemotherapy is more effective than chemotherapy alone in advanced or recurrent ovarian cancer, with a manageable safety profile, showing encouraging efficacy and tolerability.
Because conventional approaches for recurrent ovarian cancer are limited-particularly once platinum resistance develops-new therapeutic strategies are urgently needed. The best-characterized immune-checkpoint molecules are CTLA-4 and the PD-1/PD-L1 axis. Combined blockade of CTLA-4 and PD-1 has yielded impressive activity in several tumor types. Although single-agent checkpoint inhibitors produce modest response rates in recurrent ovarian cancer, preliminary data suggest that dual inhibition with anti-CTLA-4 plus anti-PD-1 antibodies may enhance therapeutic responses.QL1706 is a novel dual-target immunotherapeutic agent that has been approved for second-line monotherapy in cervical cancer.QL1706, developed by Qilu Pharmaceutical using the proprietary MabPair™ platform, is the first bispecific antibody simultaneously targeting PD-1 and CTLA-4, showing synergistic anti-tumor activity and favorable tolerability.The treatment of recurrent ovarian cancer remains a formidable challenge; therefore, proactive exploration of diverse combination regimens is essential to achieve optimal therapeutic efficacy and maximize survival benefit for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QL1706 plus chemotherapy and anlotinib regimen | Experimental | Drug: QL1706 plus chemotherapy and anlotinib regimen |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1.Capable of understanding and voluntarily signing the written Informed Consent Form (ICF); the ICF must be signed before any study-specific procedures are performed.
- 2.Female, aged 18-70 years at the time of ICF signature. 3.Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 4.Life expectancy ≥ 3 months. 5.Histologically confirmed epithelial ovarian cancer (including fallopian-tube and primary peritoneal carcinoma) that has recurred after standard platinum-based therapy:
- Note: Maintenance PARP inhibitor or bevacizumab after CR/PR to prior chemotherapy, and hormonal therapy, are not counted as additional lines of therapy.
- 6.At least one measurable lesion per RECIST v1.1. Lesions previously irradiated or treated with other loco-regional therapy can serve only as non-target lesions unless clear progression is documented or tumor viability is biopsy-proven.
- 7.Archived or freshly obtained tumor tissue (primary or relapse) must be available for biomarker analyses. Five unstained formalin-fixed paraffin-embedded (FFPE) slides or a tissue block are required for central PD-L1 testing (slides preferred). If re-biopsy is judged unsafe, the number of slides may be reduced after discussion with the medical monitor.
Key exclusion criteria (28 listed)
- 1.Non-epithelial ovarian malignancies (e.g., carcinosarcoma, sex-cord stromal tumors).
- 2.Central-nervous-system metastases or meningeal carcinomatosis. 3.Pleural, pericardial, or ascitic effusions requiring repeat drainage > once per month.
- 4.Active malignancy within 3 years before first dose, except locally curable cancers deemed cured (e.g., squamous- or basal-cell skin cancer, superficial bladder cancer, ductal carcinoma in situ of breast).
- 5.Prior systemic anti-cancer therapy within 3 weeks (chemotherapy, bevacizumab/biosimilars, TKI, PARP inhibitor); palliative radiotherapy or immunomodulators (e.g., thymosin, interferon, IL-2) or cancer-treating Chinese patent medicines (e.g., Aidi injection) within 2 weeks; hormonal agents (e.g., tamoxifen, letrozole) within 1 week.
- 6.Previous immune-checkpoint inhibitors (anti-PD-1, anti-PD-L1, anti-CTLA-4, etc.) or agonists of immune co-stimulatory molecules (ICOS, CD40, CD137, GITR, OX40, etc.).
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 |
|---|---|---|
| QL1706 plus chemotherapy and anlotinib regimenQL1706 (5 mg/kg) IV d1, q3w Pegylated liposomal doxorubicin hydrochloride (30 mg/m²) IV d1, q3w Carboplatin (AUC = 5) IV d1, q3w -OR- cisplatin (75 mg/m²) IV d1, q3w Anlotinib: 8 mg PO qd d1-14, q3w Administer for 6 cycles. | Drug | QL1706 plus chemotherapy and anlotinib regimen |
Primary outcome
Objective response rate (ORR)
Time frame: 2 years
The ratio of patients who are evaluated as CR or PR
PFS
Time frame: 2 years
PFS: defined as the time from the date of first dose to the first documented progressive disease (PD) or death from any cause, whichever occurs first, within the tumor-assessment follow-up period.
5 secondary outcomes
DCR
Time frame: 2 years
OS
Time frame: 2 years
DOR
Time frame: 2 years
TTR
Time frame: 2 years
CA125 response
Time frame: 2 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 16 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QL1706 plus chemotherapy and anlotinib regimen in people with Treatment of Recurrent Ovarian Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University at 1 site in China.
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 13 inclusion and 28 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 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 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?
Contact chen lipai (13556170919, chenlipai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 2 years). 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 16 Dec 2025.