Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

• (Dose escalation part only) 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

Locations
United States
California
University of California LA
RECRUITING
Los Angeles
Stanford University Medical Center
RECRUITING
Palo Alto
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Michigan
BAMF Health
RECRUITING
Grand Rapids
BAMF Health
RECRUITING
Grand Rapids
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Texas
Uni Of TX MD Anderson Cancer Cntr
RECRUITING
Houston
Washington
University Of Washington
RECRUITING
Seattle
Other Locations
Belgium
Novartis Investigative Site
RECRUITING
Brussels
Canada
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Toronto
France
Novartis Investigative Site
RECRUITING
Bron
Novartis Investigative Site
RECRUITING
Villejuif
Israel
Novartis Investigative Site
RECRUITING
Tel Aviv
Italy
Novartis Investigative Site
RECRUITING
Milan
Novartis Investigative Site
RECRUITING
Reggio Emilia
Netherlands
Novartis Investigative Site
RECRUITING
Utrecht
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Madrid
Switzerland
Novartis Investigative Site
RECRUITING
Geneva
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Time Frame
Start Date: 2024-10-15
Estimated Completion Date: 2030-06-26
Participants
Target number of participants: 124
Treatments
Experimental: Arm 1
Patients will receive \[68Ga\]Ga-NNS309, and if eligible, \[177Lu\]Lu-NNS309
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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