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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 (May 2026). This Phase 1 trial studies BL0175 for breast cancer.

Phase 1RecruitingShanghai Best-Link Bioscience, LLCNCT06738966Data as of May 2026

Treatment: BL0175The 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?

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Extracted eligibility criteria

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

Min 1 prior line

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.

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