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

NCT ID: NCT07261631

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-24
• Study Completion Date: 2029-05-09

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

Detailed Description

GCJ904A12101 is first-in-human (FIH), phase I, open label study that consists of a dose escalation part followed by a dose expansion part. In both parts of the study, patients will initially be imaged with a 68Ga-NNS309 positron emission tomography (PET)/ computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan and will be evaluated for eligibility for 177Lu-DFC413 treatment. Patients eligible for treatment will receive 177Lu-DFC413. In the escalation part, different doses of 177Lu-DFC413 will be tested to assess its safety, tolerability, and dosimetry and identify the recommended radioactive administered dose(s) (RD(s)) for further evaluation. The expansion will include arms based on tumor type. The end of study will occur when all 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 long-term follow-up period.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

68Ga-NNS309

Intervention Type: DRUG

Diagnostic investigational radiopharmaceutical

177Lu-DFC413

Intervention Type: DRUG

Therapeutic investigational radiopharmaceutical

Interventions

68Ga-NNS309

Diagnostic investigational radiopharmaceutical

Intervention Type: DRUG

177Lu-DFC413

Therapeutic investigational radiopharmaceutical

Intervention Type: DRUG

Eligibility Criteria

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, 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status: RECRUITING

Novartis Investigative Site

Haifa, , Israel

Site Status: RECRUITING

Novartis Investigative Site

Tel Aviv, , Israel

Site Status: RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status: RECRUITING

Countries

Canada; Israel; Singapore

Central Contacts

Novartis Pharmaceuticals

Role: CONTACT

novartis.email@novartis.com

1-888-669-6682

Novartis Pharmaceuticals

Role: CONTACT

novartis.email@novartis.com

+41613241111

Other Identifiers

2025-521702-18

Identifier Type: OTHER

Identifier Source: secondary_id

CGCJ904A12101

Identifier Type: -

Identifier Source: org_study_id