OncoMatch/Clinical Trials/NCT07660055
Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors
Is NCT07660055 recruiting? Yes, currently enrolling (Jul 2026). This Phase 1 trial studies [177Lu]Lu-DWJ155 for breast cancer.
Treatment: [177Lu]Lu-DWJ155 — The purpose of this phase I study is to evaluate the safety, tolerability, dosimetry, and preliminary anti-tumor activity of \[177Lu\]Lu-DWJ155 and the safety and imaging properties of \[68Ga\]Ga-DWJ155 in patients with histologically or cytologically confirmed advanced HER2+, HR+/HER2-negative, or triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), HER2-3+ or 2+ (ISH positive or negative) gastric/gastroesophageal junction (GEJ) cancer, and bladder cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Non-Small Cell Lung Carcinoma
Urothelial Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ or IHC 2+ (ISH + or -))
HER2+ breast cancer; HER2 IHC 3+ or 2+ (ISH + or -) gastric/GEJ cancer
Required: ESR1 expression (positive)
HR+ breast cancer
Required: PR (PGR) expression (positive)
HR+ breast cancer
Demographics
Prior therapy
Must have received: systemic therapy — advanced setting
disease progression after prior therapy in the advanced setting
Cannot have received: therapeutic radiopharmaceutical
Prior treatment with any therapeutic radiopharmaceutical
Lab requirements
Blood counts
ANC < 1.5 x 10^9/L; Hemoglobin < 9 g/dL; Platelet count < 100 x 10^9/L
Kidney function
Creatinine clearance < 60 mL/min (CKD-EPI 2021 or measured)
Liver function
Total bilirubin > 1.5 x ULN (except Gilbert's syndrome >3.0 x ULN); direct bilirubin > 1.5 x ULN; ALT > 3 x ULN (or > 5 x ULN with liver mets); AST > 3 x ULN (or > 5 x ULN with liver mets); Lipase > 1.5 x ULN
Cardiac function
Impaired cardiac function or clinically significant cardiac disease
Out-of-range laboratory values ... Impaired cardiac function or clinically significant cardiac disease
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07660055 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior therapeutic radiopharmaceutical disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for 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.
Is there an age limit?
Yes. Patients must be 100 years or younger.
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