OncoMatch/Clinical Trials/NCT06293898
Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors
Is NCT06293898 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Other
Cancer type
Endometrial Cancer
Cervical Cancer
Ovarian Cancer
Urothelial Carcinoma
Cholangiocarcinoma
Breast Carcinoma
Non-Small Cell Lung Carcinoma
Small Cell Lung Cancer
Gastric Cancer
Esophageal Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) expression (IHC 1+ to 3+)
HER2-expressing (IHC 1+ to 3+ ... in tumor specimen by ISH or NGS)
Required: HER2 (ERBB2) amplification
HER2 gene amplification ... in tumor specimen by ISH or NGS
Required: HER2 (ERBB2) activating mutation
HER2 ... activating mutation ... in tumor specimen by ISH or NGS
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard therapy
has received at least 2 lines of standard therapy, including adjuvant/neoadjuvant treatment, or whose cancer is considered refractory to the standard of care or for which no standard treatment is available
Cannot have received: topoisomerase inhibitor antibody-drug conjugate
Exception: If the topoisomerase I ADC is sacituzumab govitecan, prior discussion with the medical monitor is required for potential inclusion
For Dose Expansion Only: Prior treatment with any topoisomerase inhibitor ADC
Lab requirements
Blood counts
ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥9.0 g/dL (no transfusion, erythropoietin, hematopoiesis agents, or G-CSF 1 week prior to screening)
Kidney function
Creatinine clearance ≥50 mL/min (dose escalation/finding) or ≥40 mL/min (dose expansion); eGFR ≥50 mL/min/1.73 m² (dose escalation/finding) or ≥40 mL/min/1.73 m² (dose expansion)
Liver function
Total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert's syndrome or liver metastasis at baseline), AST and ALT without liver metastasis ≤3.0×ULN, AST and ALT with liver metastasis ≤5.0×ULN
Cardiac function
No serious cardiac dysfunction, LVEF ≥50%, no symptomatic CHF ≥ Grade 2, no NYHA ≥ Grade 2, no MI or unstable angina within 6 months, no prolonged QTcF >470 msec, no complete LBBB, no Grade 3 AV block
No serious cardiac dysfunction, left ventricular ejection fraction ≥50%; Adequate organ function before enrollment, defined as: ... (see full criterion 10-11)
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 →Frequently asked questions
Is NCT06293898 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior topoisomerase inhibitor antibody-drug conjugate disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 activating mutation 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.
Check if I qualify