OncoMatch/Clinical Trials/NCT06738966
A Study of BL0175 Injection in Postmenopausal Female Adults With HR-positive, Locally Advanced or Metastatic Cancer
Is NCT06738966 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies BL0175 for breast cancer.
Treatment: BL0175 — 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?
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Ovarian Cancer
Endometrial Cancer
Biomarker criteria
Required: ESR1 expression (positive)
presence of ER and/or PR expression
Required: PR (PGR) expression (positive)
presence of ER and/or PR expression
Required: HER2 (ERBB2) wild-type (absence of HER2 expression)
HER2-negative (characterized by the absence of HER2 expression)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — locally advanced or metastatic breast cancer
disease progression during or following endocrine therapy
Must have received: standard of care therapy — locally advanced or metastatic ovarian cancer or endometrial cancer
progressed during or following prior standard of care therapy
Cannot have received: antitumor drug or investigational drug
Exception: washout periods specified for each class
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).
Lab requirements
Blood counts
ANC ≥ 1.5×10^9/L; Hemoglobin ≥ 90 g/L; Platelets ≥ 100×10^9/L
Kidney function
Creatinine clearance ≥ 30 mL/min
Liver function
Total bilirubin ≤ 1.5×ULN; AST or ALT ≤ 3×ULN without liver metastases or primary liver cancer; AST or ALT ≤ 5×ULN if the patient has documented liver metastases
Cardiac function
No NYHA class III-IV cardiac insufficiency or LVEF < 50%; no poorly controlled arrhythmia (QTc > 480 ms or congenital long QT); no recent (within 6 months) MI, unstable angina, CHF, CVA, symptomatic PE or other significant thromboembolic disease, or CABG; no clinically symptomatic bradycardia; no other clinically significant cardiovascular disease as assessed by investigator
Patients who have impaired cardiac function or clinically significant cardiac diseases, including any of the following: NYHA class III-IV for cardiac insufficiency or LVEF < 50%... [see full text for details]. Patients who have not sufficient baseline organ function and whose laboratory data meet the following criteria at enrollment: ANC < 1.5×10^9/L. Total bilirubin > 1.5×ULN. AST or 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 < 100×10^9 /L. Creatinine clearance < 30 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06738966 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antitumor drug or investigational drug disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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