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

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

NCT ID: NCT06562192

Condition: Pancreatic Ductal Adenocarcinoma
Non-small Cell Lung Cancer
HR+/HER2- Ductal and Lobular Breast Cancer
Triple Negative Breast Cancer
Colorectal Cancer

Conditions: Official terms:
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Adenocarcinoma
Triple Negative Breast Neoplasms

Conditions: Keywords:
pancreatic ductal adenocarcinoma
non-small cell lung cancer
breast cancer
colorectal cancer
radioligand therapy (RLT)
[177Lu]Lu-NNS309
[68Ga]Ga-NNS309

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: [68Ga]Ga-NNS309
Description: Radioligand imaging agent
Arm group label: Arm 1

Intervention type: Drug
Intervention name: [177Lu]Lu-NNS309
Description: Radioligand therapy
Arm group label: Arm 1

Summary: The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-NNS309 and the safety and imaging properties of [68Ga]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).

Detailed description: The study will be done in two parts. The first part is called "escalation" and the second part is called "expansion". In both parts of the study, patients will initially be imaged with a [68Ga]Ga-NNS309 positron emission tomography (PET)/ computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan and will be evaluated for eligibility for [177Lu]Lu-NNS309 treatment. In the escalation part, different doses of [177Lu]Lu-NNS309 will then be tested to identify recommended dose(s) (RD(s)) for further evaluation. The expansion part of the study will examine the safety and preliminary efficacy of [177Lu]Lu-NNS309 at the RD(s) determined during the escalation part. The end of study will occur when at least 80% of the patients per disease group in the expansion part have completed the follow-up for disease progression or discontinued from the study for any reason, and all patients have completed treatment and the 36-month long-term follow-up period.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age ≥ 18 years old - Patients with one of the following indications: - Locally advanced unresectable or metastatic PDAC who have received prior treatment with at least 1 line of cytotoxic chemotherapy, unless patient was ineligible to receive such therapy - Locally advanced unresectable or metastatic NSCLC without any actionable genomic alterations who have received prior treatment with chemotherapy and immunotherapy, unless patient was ineligible to receive such therapy, or locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration who have received prior treatment with 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 - Locally advanced unresectable or metastatic TNBC with disease progression following, or intolerance to, at least 2 lines of therapy - (Dose escalation part only) Locally advanced or metastatic unresectable CRC who have received prior therapy with at least 1 line of 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 received 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 109/L, hemoglobin < 10 g/dL, or platelet count < 100 x 109/L - QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec - Creatinine clearance < 60 mL/min - 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Novartis Investigative Site

Address:
City: Tel Aviv
Zip: 6423906
Country: Israel

Status: Recruiting

Start date: September 30, 2024

Completion date: June 26, 2030

Lead sponsor:
Agency: Novartis Pharmaceuticals
Agency class: Industry

Source: Novartis

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06562192