OncoMatch/Clinical Trials/NCT06293898
Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
Is NCT06293898 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BL-M07D1 for endometrial cancer.
Treatment: BL-M07D1 — The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Endometrial Cancer
Cervical Cancer
Ovarian Cancer
Urothelial Carcinoma
Cholangiocarcinoma
Breast Carcinoma
Non-Small Cell Lung Carcinoma
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) activating mutation
Required: HER2 (ERBB2) amplification
Required: HER2 (ERBB2) overexpression (ihc 1+ to 3+)
Disease stage
Metastatic disease required
documented locally advanced or metastatic HER2expressing (IHC 1+ to 3+ and/or HER2 gene amplification or activating mutation in tumor specimen by ISH or NGS) solid tumor(s) not amenable to curative surgery or radiation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
Chemotherapy ... within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
Cannot have received: biological therapy
Exception: within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
biological therapy ... within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
Cannot have received: immunotherapy
Exception: within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
immunotherapy ... within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
Cannot have received: radical radiotherapy
Exception: within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
radical radiotherapy ... within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
Cannot have received: targeted therapy
Exception: within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
targeted therapy (including small molecule inhibitor of tyrosine kinase) ... within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration
Cannot have received: mitomycin
Exception: within 6 weeks prior to the first administration
mitomycin ... within 6 weeks prior to the first administration
Cannot have received: nitrosoureas
Exception: within 6 weeks prior to the first administration
nitrosoureas treatment within 6 weeks prior to the first administration
Cannot have received: anthracycline
Exception: cumulative dose exceeding 360 mg/m2
Subjects who have received treatment with anthracyclines with a cumulative dose exceeding 360 mg/m2
Lab requirements
Blood counts
adequate organ function before enrollment
Kidney function
adequate organ function before enrollment
Liver function
adequate organ function before enrollment
Cardiac function
no serious cardiac dysfunction, left ventricular ejection fraction ≥50%
Has adequate organ function before enrollment, defined as: ... Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5 ULN, unless receiving anticoagulation therapy with prothrombin time and aPTT levels within the intended therapeutic range; Urinary protein ≤2+ or ≤1000 mg/24 hours; Has no serious cardiac dysfunction, left ventricular ejection fraction ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama Birmingham · Birmingham, Alabama
- City of Hope · Duarte, California
- Cedars Sinai · Los Angeles, California
- Scripps Health · San Diego, California
- University of Miami · Miami, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify