Recruiting
Phase 1

\[177Lu\]Lu-DFC413, \[68Ga\]Ga-NNS309

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07261631

Conditions

Pancreatic Ductal Adenocarcinoma

Non-Small Cell Lung Cancer

HR+/HER2- Ductal and Lobular Breast Cancer

Triple Negative Breast Cancer

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

68Ga-NNS309

177Lu-DFC413

Study Details

Brief summary:

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-DFC413 and safety and imaging properties of \[68Ga\]Ga-NNS309 in patients aged ≥ 18 years with solid tumors

Conditions

Pancreatic Ductal Adenocarcinoma

Non-Small Cell Lung Cancer

HR+/HER2- Ductal and Lobular Breast Cancer

Triple Negative Breast Cancer

Colorectal Cancer

Study ID

NCT07261631

Start date

Nov 24, 2025

Status verified date

Oct, 2026

Completion date

May 9, 2029

Anticipated

Primary completion date

May 9, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults ≥ 18 years with one of the following indications:
  • Locally advanced unresectable or metastatic PDAC, with disease progression following, or intolerance to cytotoxic therapy, 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 chemotherapy and targeted therapy, unless patient was ineligible to receive such therapy
  • Locally advanced unresectable or metastatic HR+/HER2- ductal and lobular breast cancer with disease progression following, or intolerance to, hormone therapy and CDK inhibitor, and at least one additional line of therapy, unless patient was ineligible to receive such therapy
  • Locally advanced unresectable or metastatic triple negative breast cancer (TNBC) with disease progression following, or intolerance to, at least two 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
  • (Dose expansion only) Locally advanced unresectable or metastatic soft tissue sarcoma (excluding GIST and Kaposi) with disease progression following, or intolerance to, at least one line of systemic therapy
  • Patients must have lesions showing 68Ga-NNS309 uptake

Exclusion Criteria:

  • Absolute neutrophil count (ANC) < 1.5 x 109/L, hemoglobin < 9 g/dL, or platelet count < 100 x 109/L
  • QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec
  • eGFR < 60 mL/min/1.73m2, calculated using CKD-EPI 2021 or measured
  • Unmanageable urinary tract obstruction or urinary incontinence
  • Presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy
  • Any prior radioligand therapy
  • Radiation therapy within 4 weeks prior to the first dose of \[177Lu\]Lu-DFC413

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Enrollment

180 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1

Patients will receive 68Ga-NNS309 and only patients with tumor uptake will receive 177Lu-DFC413

Interventions

68Ga-NNS309

Diagnostic investigational radiopharmaceutical

177Lu-DFC413

Therapeutic investigational radiopharmaceutical

Primary outcome measure

  • Incidence and severity of dose limiting toxicities of 177Lu-DFC413 [ Time Frame: Within first treatment cycle, up to maximum 6 weeks ]
  • Incidence and severity of adverse events and serious adverse events of 177Lu-DFC413 [ Time Frame: From study treatment start up to approximately 42 months ]
  • Dose modifications for 177Lu-DFC413 [ Time Frame: From study treatment start until last dose of study treatment, assessed up to approximately 24 weeks ]
  • Dose intensity for 177Lu-DFC413 [ Time Frame: From study treatment start until last dose of study treatment, assessed up to approximately 24 weeks ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111novartis.email@novartis.com

Locations

United Theranostics

Recruiting

Princeton, New Jersey, United States, 08540

Contacts

Jessica DeBerry

+1 609 300 2858jdeberry@unithera.com

Principal Investigator:

Munir Ghesani

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • PDAC
  • NSCLC
  • Breast cancer
  • CRC
  • STS
  • Radioligand therapy (RLT)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.