A Study of BL0175 Injection in Postmenopausal Female Adults With HR-positive, Locally Advanced or Metastatic Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Best-Link Bioscience, LLC
About this trial
The goal of this clinical trial is to learn if the investigational drug BL0175 works to treat adult postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor (HER2)-negative locally advanced or metastatic breast cancer, ovarian cancer and endometrial cancer. It will also learn about the safety of BL0175. The main questions it aims to answer are:
* Does the investigational drug BL0175 is safe for participants after dosed -multiple times? * Which is the highest safety dose of BL0175 after multiple dose? * What medical problems do participants have when using BL0175? * Does the investigational drug BL0175 works for participants after dosed -multiple times?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Age ≥ 18 years.
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.
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.
Disqualifiers
Patients with symptomatic central nervous system (CNS) metastases or carcinomatous meningitis.
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.
Patients whose pericardial effusion, pleural effusion or ascites remain uncontrollable after intervention.
Patients with a history of allogeneic transplantation of organs, bone marrow or stem cell.
Trial design
Design model
Sequential
Treatments tested in this trial
BL0175
DrugBL0175 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.
Treatment groups
9 Participants
are divided into 5 treatment groupsGroup A: BL0175 50 mgExperimental treatment 1 intervention
Group B: BL0175 100 mgExperimental treatment 1 intervention
Group C: BL0175 200 mgExperimental treatment 1 intervention
Group D: BL0175 400 mgExperimental treatment 1 intervention
Group E: BL0175 500 mgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame
From enrollment to the end of treatment at 8 weeksSecondary outcomes
1
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame
0, 3, 6, 24, 48, 72, 96, 168, 240, 336 hours post first and sixth dose; before the third, fourth and fifth dose2
Maximum Blood Concentration of Investigational Drug
Time frame
0, 3, 6, 24, 48, 72, 96, 168, 240, 336 hours post first and sixth dose; before the third, fourth and fifth dose3
Trough Blood Concentration of Investigational Drug
Time frame
0, 3, 6, 24, 48, 72, 96, 168, 240, 336 hours post first and sixth dose; before the third, fourth and fifth dose4
Half-life of Investigational Drug
Time frame
0, 3, 6, 24, 48, 72, 96, 168, 240, 336 hours post first and sixth dose; before the third, fourth and fifth doseSponsors and contacts
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Source ClinicalTrials.gov