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.
Male or female patients age ≥ 18 years.
Advanced HER2+ breast cancer with disease progression after at least two prior lines of systemic therapy in the advanced setting
Advanced HR+/HER2-low breast cancer with disease progression after prior therapy in the advanced setting
Advanced NSCLC without actionable genetic alterations (AGAs) with disease progression after prior therapy in the advanced setting
Creatinine clearance < 60 mL/min (calculated using CKD-EPI 2021 formula, or measured)
Total bilirubin > 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin >3.0 x ULN) or direct bilirubin > 1.5 x ULN
Alanine aminotransferase (ALT) > 3 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT > 5 x ULN
Aspartate aminotransferase (AST) > 3 x ULN, except for patients with tumor involvement of the liver who are excluded if AST > 5 x ULN
Sequential
[68Ga]Ga-DWJ155
Diagnostic testRadioligand imaging agent
[177Lu]Lu-DWJ155
DrugRadioligand therapy
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) of [177Lu]Lu-DWJ155
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, echocardiograms (ECGs), and imaging assessments qualifying and reported as AEs.
Incidence of dose-limiting toxicities (DLTs) of [177Lu]Lu-DWJ155
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness/injury or concomitant medications that occurs within the first treatment cycle. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Frequency of dose interruptions and reductions [177Lu]Lu-DWJ155
Number of participants with dose interruptions and/or reductions to assess the tolerability.
Dose intensity [177Lu]Lu-DWJ155
Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure
Overall Response Rate (ORR) per RECIST v1.1
ORR is defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) as per local review and according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Disease Control Rate (DCR) per RECIST v1.1
DCR is defined as the proportion of patients with a BOR of CR, PR, or stable disease (SD) as per local review and according to RECIST v1.1.
Duration of Response (DOR) per RECIST v1.1
DOR is the time between the first documented response (CR or PR) and the date of progression as per local review and according to RECIST v1.1, or death due to any cause.
Progression-Free Survival (PFS) per RECIST v1.1
PFS is defined as the time from the date of start of treatment to the date of the first documented progression as per local review and according to RECIST v1.1 or death due to any cause.
Click on the lead sponsor to view all of their trials.