OncoMatch/Clinical Trials/NCT05461768
A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors
Is NCT05461768 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BL-M07D1 for breast cancer.
Treatment: BL-M07D1 — In phase Ia study, the safety and tolerability of BL-B07D1 in patients with locally advanced or metastatic HER2-positive/low-expression breast cancer and other solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-M07D1. In phase Ib study, the safety and tolerability of BL-M07D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-M07D1 in patients
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Tumor Agnostic
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC3+ OR IHC2+ and ISH positive)
HER2 positive: IHC3+, or IHC2+ and ISH positive
Required: HER2 (ERBB2) low expression (IHC2+ and ISH negative OR IHC1+)
HER2 low expression: IHC2+ and ISH negative, or IHC1+
Disease stage
Metastatic disease required
Inoperable locally advanced or metastatic HER2-positive/low-expression breast cancer and other solid tumors
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: within 4 weeks or 5 half-lives (whichever is less) prior to initial dosing
Prior use of chemotherapy ... within 4 weeks or 5 half-lives (whichever is less) prior to initial dosing
Cannot have received: biotherapy
Exception: within 4 weeks or 5 half-lives (whichever is less) prior to initial dosing
Prior use of biotherapy ... within 4 weeks or 5 half-lives (whichever is less) prior to initial dosing
Cannot have received: immunotherapy
Exception: within 4 weeks or 5 half-lives (whichever is less) prior to initial dosing
Prior use of immunotherapy ... within 4 weeks or 5 half-lives (whichever is less) prior to initial dosing
Cannot have received: radical radiotherapy
Exception: within 4 weeks or 5 half-lives (whichever is less) prior to initial dosing
Prior use of ... radical radiotherapy ... within 4 weeks or 5 half-lives (whichever is less) prior to initial dosing
Cannot have received: major surgery
Exception: within 4 weeks or 5 half-lives (whichever is less) prior to initial dosing
Prior use of ... major surgery (as defined by the investigator) ... within 4 weeks or 5 half-lives (whichever is less) prior to initial dosing
Cannot have received: targeted therapy
Exception: within 4 weeks or 5 half-lives (whichever is less) prior to initial dosing
Prior use of ... targeted therapy (including small molecule tyrosine kinase inhibitors) ... within 4 weeks or 5 half-lives (whichever is less) prior to initial dosing
Cannot have received: antitumor therapy
Exception: within 4 weeks or 5 half-lives (whichever is less) prior to initial dosing
Prior use of ... other antitumor therapies within 4 weeks or 5 half-lives (whichever is less) prior to initial dosing
Cannot have received: alkylating agent (mitomycin, nitrosourea)
Exception: within 6 weeks prior to initial administration
Mitomycin and nitrosourea were administered within 6 weeks prior to initial administration
Cannot have received: antimetabolite (capecitabine)
Exception: oral fluorouracil drugs such as gio, capecitabine, or palliative radiotherapy within 2 weeks before initial administration
For oral fluorouracil drugs such as gio, capecitabine, or palliative radiotherapy within 2 weeks before initial administration
Cannot have received: antibody-drug conjugate
Exception: phase Ib only; with the toxin of camptothecin derivatives (topoisomerase I inhibitors)
Prior ADC treatment (phase Ib only) with the toxin of camptothecin derivatives (topoisomerase I inhibitors)
Lab requirements
Blood counts
absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count ≥90×10^9/L, hemoglobin ≥90 g/L
Kidney function
creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min
Liver function
total bilirubin (TBIL≤1.5 ULN), AST and ALT ≤2.5 ULN in patients without liver metastasis, AST and ALT ≤5.0 ULN in patients with liver metastasis
Cardiac function
No serious cardiac dysfunction, left ventricular ejection fraction ≥50%
Organ function level must meet the following requirements ... Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count ≥90×10^9/L, hemoglobin ≥90 g/L; Liver function: total bilirubin (TBIL≤1.5 ULN), AST and ALT ≤2.5 ULN in patients without liver metastasis, AST and ALT ≤5.0 ULN in patients with liver metastasis; Renal function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min ... No serious cardiac dysfunction, left ventricular ejection fraction ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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