Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers

Official record

Identifier

NCT06562192

Recruiting locations

countries

United StatesBelgiumCanadaFranceGermanyIsraelItalyNetherlandsSpainSwitzerland

Interventions studied

[68Ga]Ga-NNS309[177Lu]Lu-NNS309

Lead sponsor

Novartis Pharmaceuticals

Target enrolment

162 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Recruiting

First posted

Aug 20, 2024

Last updated on the registry

Jul 29, 2026

Age

18 Years – 100 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* Age ≥ 18 years old
* Patients with one of the following indications:
* Locally advanced unresectable or metastatic PDAC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy
* Locally advanced unresectable or metastatic NSCLC without any actionable genomic alterations with disease progression following, or intolerance to chemotherapy and immunotherapy, unless patient was ineligible to receive such therapy, or locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration with disease progression following, or intolerance to targeted therapy, unless patient was ineligible to receive such therapy
* Locally advanced unresectable or metastatic HR+/HER2- ductal or lobular BC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy
* Locally advanced unresectable or metastatic TNBC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy
* Locally advanced or metastatic unresectable CRC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy. Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status must also have had disease progression following, or intolerance to immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy
* Patients must have lesions showing 68Ga-NNS309 uptake

Exclusion Criteria:

* Absolute neutrophil count (ANC) \< 1.5 x 10\^9/L, hemoglobin \< 9 g/dL, or platelet count \< 100 x 10\^9/L
* QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec
* Calculated estimated glomerular filtration rate \< 60 mL/min/1.73m2
* Unmanageable urinary tract obstruction or urinary incontinence
* Radiation therapy within 4 weeks prior to the first dose of \[177Lu\]Lu-NNS309

Other protocol-defined inclusion/exclusion criteria may apply.