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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06738966




Registration number
NCT06738966
Ethics application status
Date submitted
9/12/2024
Date registered
18/12/2024

Titles & IDs
Public title
A Study of BL0175 Injection in Postmenopausal Female Adults with HR-positive, Locally Advanced or Metastatic Cancer
Scientific title
An International, Multi-Center, Open-label Phase I Study to Evaluate the Tolerance, Pharmacokinetics, and Anti-Tumor Effects of BL0175 Injection in Postmenopausal Female Adults with HR-positive, Locally Advanced or Metastatic Cancer
Secondary ID [1] 0 0
BL0175-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Ovarian Cancer 0 0
Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BL0175

Experimental: BL0175 50 mg -

Experimental: BL0175 100 mg -

Experimental: BL0175 200 mg -


Treatment: Drugs: BL0175
BL0175 is a nano-medicine for cancer therapy. "Nano-medicine" means the tiny size of this study drug allows it to enter and concentrate into the tumor tissue. This is a new way of delivering an active drug (an estrogen receptor down regulator) for the treatment of tumor directly into tumor tissue.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Timepoint [1] 0 0
From enrollment to the end of treatment at 8 weeks
Secondary outcome [1] 0 0
Area Under the Plasma Concentration Versus Time Curve (AUC)
Timepoint [1] 0 0
0, 3, 6, 24, 48, 72, 96, 168, 240, 336 hours post first and sixth dose; before the third, fourth and fifth dose
Secondary outcome [2] 0 0
Maximum Blood Concentration of Investigational Drug
Timepoint [2] 0 0
0, 3, 6, 24, 48, 72, 96, 168, 240, 336 hours post first and sixth dose; before the third, fourth and fifth dose
Secondary outcome [3] 0 0
Trough Blood Concentration of Investigational Drug
Timepoint [3] 0 0
0, 3, 6, 24, 48, 72, 96, 168, 240, 336 hours post first and sixth dose; before the third, fourth and fifth dose
Secondary outcome [4] 0 0
Half-life of Investigational Drug
Timepoint [4] 0 0
0, 3, 6, 24, 48, 72, 96, 168, 240, 336 hours post first and sixth dose; before the third, fourth and fifth dose
Secondary outcome [5] 0 0
Progression Free Survival
Timepoint [5] 0 0
From enrollment to the date of disease progress, usually of 6 months
Secondary outcome [6] 0 0
One year survival rate
Timepoint [6] 0 0
From enrollment to the time of 12 months

Eligibility
Key inclusion criteria
1. Volunteer to participate in the study, be able to understand the requirements of a clinical study, and willingness to sign a written informed consent form.
2. Age = 18 years.
3. HR-positive, HER2-negative (characterized by the absence of HER2 expression and the presence of ER and/or PR expression) locally advanced or metastatic breast cancer (histological or cytological proven diagnosis) in postmenopausal women with disease progression during or following endocrine therapy, or HR-positive, locally advanced or metastatic ovarian cancer or endometrial cancer in postmenopausal women that progressed during or following prior standard of care therapy. Note: to be included in this study, patients must have received prior treatment with a CDK4/6 inhibitor.
4. Patients with at least one measurable or evaluable lesion: At least one lesion (measurable and/or non-measurable) that can be accurately assessed by CT/MRI/plain x-ray at baseline and follow up visit.

Note: Measurable lesions cannot be selected from the following sites in principle: having received prior radiotherapy or having received other local therapy. If a target lesion at a site that has received prior radiotherapy or other local therapy is the only optional lesion, the progression of the lesion shall be confirmed by the investigator.
5. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening.
6. Life expectancy period = 12 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with symptomatic central nervous system (CNS) metastases or carcinomatous meningitis.

Note: patients with treated CNS metastases may participate in this study if the patient has completed radiotherapy or surgery for CNS metastases = 4 weeks prior to study entry, and if the patient is neurologically stable = 2 weeks after radiotherapy or surgery treatment (no new neurologic deficits from brain metastasis on screening clinical examination, no new findings on CNS imaging, and corticosteroids were not required within 2 weeks prior to enrollment).
2. Patients who have a history of another primary malignancy (with the exception of participants with cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of uterine cervix). A patient who has had no evidence of disease from another primary cancer for 3 or more years is allowed to participate in the study.
3. Patients whose pericardial effusion, pleural effusion or ascites remain uncontrollable after intervention.
4. Patients with a history of allogeneic transplantation of organs, bone marrow or stem cell.
5. A history of allergic or adverse response(s) to fulvestrant, or prone to allergic reactions (such as: prone to angioedema, urticaria, asthma, rash, etc.).
6. Patients who have impaired cardiac function or clinically significant cardiac diseases, including any of the following:

* New York Heart Association class III-IV for cardiac insufficiency or left ventricular ejection fraction < 50% (if the LVEF data is available).
* Patients with poorly controlled arrhythmia: QTc interval > 480 ms calculated by Fridericia's formula, or congenital syndrome of prolonged QT interval.
* Any of the following within 6 months prior to the enrollment: myocardial infarction, severe or unstable angina, congestive heart failure, cerebrovascular accident (including transient ischemic attack), symptomatic pulmonary embolism or other clinically significant thromboembolic disease, or coronary artery bypass graft.
* Clinically symptomatic bradycardia as assessed by the investigator.
* Patients with other clinically significant cardiovascular disease who were assessed as unsuitable for this study by the investigator.
7. Patients who have a known diagnosis of Human Immunodeficiency Virus (HIV) infection or HIV antibody test positive in screening.
8. Patients with active hepatitis C or chronic hepatitis B at screening ("active hepatitis" defined as HCV RNA level = 200 IU/mL for hepatitis C or HBV DNA level = 2000 IU/mL for hepatitis B at screening). In addition, eligible hepatitis B or hepatitis C patients must agree to antiviral treatment according to the treatment guidelines.
9. Active infections requiring antibiotic intravenous therapy within 1 weeks prior to enrollment.
10. Moderate or severe hepatic impairment (Child-Pugh class B or C).
11. Patients who have not sufficient baseline organ function and whose laboratory data meet the following criteria at enrollment [No transfusion of blood products (including platelets or red blood cells) or use of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days prior to screening]:

* Absolute Neutrophil Count (ANC) < 1.5×109/L.
* Total bilirubin > 1.5×ULN.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3×ULN without liver metastases or primary liver cancer. AST or ALT > 5×ULN if the patient has documented liver metastases.
* Hemoglobin < 90 g/L.
* Platelets < 100×109 /L.
* Creatinine clearance < 30 mL/min.
12. Prior to first dose of the investigational product, received an antitumor drug or investigational drug at the following time intervals:

* Chemotherapy, targeted small molecule therapy or radiotherapy (except palliative radiotherapy and the radiotherapy area do not include the proposed target lesion) = 14 days. The wash-out period for TKI drugs is more than 5 half-lives could enroll for their shorter half-life.
* Immunotherapy or cell therapy (i.e. chimeric antigen receptor T cell therapy) = 28 days; Other cell therapy must be discussed with the investigators to determine eligibility.
* Monoclonal antibodies = 28 days for anticancer therapy.
* Anti-tumor Chinese medicine which approved by the agency = 14 days.
* Immunosuppressive therapy for any reason = 7 days.
* Fulvestrant = 250 days (5 half-lives).
* All other investigational drugs or devices = 28 days or 5 half-lives before the first dosing administration (whichever is shorter).
13. Bleeding constitution (e.g., diffuse intravascular coagulation [DIC], clotting factor deficiency), or long-term anticoagulant therapy (excluding antiplatelet therapy and low doses of warfarin and low molecular weight heparin).
14. Severe vascular embolism events requiring medical or surgical intervention.
15. Active autoimmune diseases that require systemic treatment (i.e. use of immunomodulators, corticosteroids, or immunosuppressive drugs).

Note: Participants with hyperthyroidism/hypothyroidism could participate. Note: Hormone replacement therapy and symptomatic therapy (e.g., levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered a form of systemic therapy and are permitted.
16. Those who have received systemic corticosteroids within 4 weeks prior to administration of BL0175 or active control (low doses of corticosteroids are excluded, such as = 20 mg prednisone daily or equivalent).
17. Those who underwent major surgery within 4 weeks before enrollment, or plan to undergo major surgery during the study.
18. Has not recovered from the toxic effects of prior treatment (including prior immunotherapy) and/or complications of surgical intervention to CTCAE v5.0 = 1.

Note: Participants with stable chronic AE (= grade 2) that are not expected to resolve on their own (e.g., peripheral neuropathy and alopecia) are allowed.
19. Those who are determined disqualified to join clinical studies by investigator for other causes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
20/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/12/2027
Actual
Sample size
Target
9
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shanghai Best-Link Bioscience, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Guat Hoon Ong
Address 0 0
Country 0 0
Phone 0 0
+65 9726 6883
Fax 0 0
Email 0 0
gho@zhangjiang-bio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06738966