Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors

NCT07261631 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: CGCJ904A121012025-521702-18
• Study Type: interventional
• Target: 180
• Locations: 6 countries
• Sites: 7

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; Soft Tissue Sarcoma

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Incidence and severity of dose limiting toxicities of 177Lu-DFC413

  A dose limiting toxicity (DLT) is defined as any adverse event or abnormal laboratory value of CTCAE (version 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 clinically significant toxicities may be considered to be DLTs, even if not Grade 3 or higher.

  Within first treatment cycle, up to maximum 6 weeks

• Incidence and severity of adverse events and serious adverse events of 177Lu-DFC413

  The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs) and Serious Adverse Event (TESAEs) and through the monitoring of relevant clinical and laboratory safety parameters.

  From study treatment start up to approximately 42 months

• Dose modifications for 177Lu-DFC413

  Dose modifications (dose interruptions and reductions) for 177Lu-DFC413 will be assessed and summarized using descriptive statistics. The number of patients with dose modification and the reasons will be summarized by treatment groups.

  From study treatment start until last dose of study treatment, assessed up to approximately 24 weeks

• Dose intensity for 177Lu-DFC413

  Dose intensity for 177Lu-DFC413 will be assessed and summarized using descriptive statistics. Dose intensity is computed as the ratio of actual cumulative dose received and actual duration of exposure.

  From study treatment start until last dose of study treatment, assessed up to approximately 24 weeks

Secondary Outcomes (15)

• Overall response rate (ORR)

  From study treatment start up to 6 months

• Duration of Response (DOR)

  From study treatment start up to 6 months

• Disease control rate (DCR)

  From study treatment start up to 6 months

• Progression free survival (PFS)

  From study treatment start up to 6 months

• Area Under the Curve (AUC) of 177Lu-DFC413

  Up to 8 days after first dose

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Drug: 68Ga-NNS309; Drug: 177Lu-DFC413

Interventions

68Ga-NNS309 DRUG

Diagnostic investigational radiopharmaceutical

Arm 1

177Lu-DFC413 DRUG

Therapeutic investigational radiopharmaceutical

Arm 1

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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, 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (7)

Novartis Investigative Site

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Novartis Investigative Site

Odense C, 5000, Denmark

RECRUITING

Novartis Investigative Site

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Novartis Investigative Site

Essen, 45147, Germany

RECRUITING

Novartis Investigative Site

Haifa, 3109601, Israel

RECRUITING

Novartis Investigative Site

Tel Aviv, 6423906, Israel

RECRUITING

Novartis Investigative Site

Singapore, 168583, Singapore

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Triple Negative Breast Neoplasms; Colorectal Neoplasms; Sarcoma; Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

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

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): May 9, 2029
• Study Completion (Estimated): May 9, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); FR (1); IL (2); SG (1); CA (1); DK (1)