solid tumor
Conditions
Interventions
- Drug: 225Ac-ETN029
- Radioligand therapy
- Drug: 111In-ETN029
- Radioligand imaging agent
Sponsors
Moizumi Sanae
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >= 18 years old - Patients with one of the following indications: - Locally advanced, unresectable, or metastatic SCLC with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy, unless patient was ineligible to receive such therapy. Prior DLL3-targeted therapy is allowed. For dose expansion, patients should have received no more than 2 prior lines of systemic therapy. - Dose escalation only: LCNEC of the lung with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy, unless patient was ineligible to receive such therapy. - Dose expansion only: Locally advanced, unresectable, or metastatic de novo or castration-resistant, treatment-emergent NEPC with neuroendocrine differentiation confirmed by local histology and NEPC marker expression (e.g., chromogranin, synaptophysin) confirmed by local IHC. Prior PSMA-targeted, Lu-177-based RLT is allowed. Patients must have at least one measurable lesion (per RECIST 1.1) that shows 111In-ETN029 uptake higher than surrounding tissues on SPECT/CT as assessed by the Investigator. - Dose expansion only: Locally advanced, unresectable, or metastatic GEP-NEC with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy, unless patient was ineligible to receive such therapy. Patients must have at least one measurable lesion (per RECIST 1.1) that shows 111In-ETN029 uptake higher than surrounding tissues on SPECT/CT as assessed by the Investigator.
Exclusion criteria
Exclusion criteria: - Absolute neutrophil count (ANC) = 470 msec - eGFR = Grade 2 - Any prior DLL3-targeted therapy (except for SCLC) and any prior RLT (except for NEPC)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Number of patients with dose limiting toxicities of 225Ac-ETN029 [Time Frame: From the start of study treatment until 6 weeks after] - A dose limiting toxicity (DLT) is defined as any adverse event or abnormal laboratory value of CTCAE 5.0 grade 3 or higher that occurs within the DLT evaluation period and that is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications with a few exceptions defined in the study protocol. Other significant toxicities may be considered to be DLTs, even if not Grade 3 or higher. - Incidence and severity of adverse events and serious adverse events of 225Ac-ETN029 [Time Frame: From start of study treatment until completion of the 36 month follow up, assessed up to approximately 42 months] - Incidence and severity of treatment-emergent adverse events and serious adverse events, including changes in laboratory values, vital signs, and electrocardiograms qualifying and reported as AEs - Dose modifications for 225Ac-ETN029 [Time Frame: From the start of study treatment until last dose of study treatment, assessed as approximately 24 weeks] - Number of dose modifications (e.g, dose interruptions and reductions) for 225Ac-ETN029 - Dose intensity for 225Ac-ETN029 [Time Frame: From start of study treatment until last dose of study treatment, assessed as approximately 24 weeks] - Dose intensity of 225Ac-ETN029 defined as the ratio of actual cumulative dose received and actual duration of exposure | — |
Countries
Canada, Japan, South Korea, US
Contacts
Public ContactSanae Moizumi
Novartis Pharma. K.K.
Outcome results
None listed