Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors

NCT07630961 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: CJFI447A021012025-523665-24
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of Part 1 of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics of \[68Ga\]Ga-DFC413, and in Part 2 compare to \[68Ga\]Ga-NNS309 in patients 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), colorectal cancer (CRC), and soft tissue sarcoma (STS). In Part 2 of this study (comparison of \[68Ga\]Ga-DFC413 and \[68Ga\]Ga-NNS309), not all indications might be explored.

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma (PDAC); Non-small Cell Lung Cancer (NSCLC); HR+/HER2- Ductal Breast Cancer (BC); HR+/HER2- Lobular Breast Cancer (BC); Triple Negative Breast Cancer (TNBC); Colorectal Cancer (CRC); Soft Tissue Sarcoma (STS)

Keywords

metastatic pancreatic ductal adenocarcinoma (PDAC); non-small cell lung cancer (NSCLC); HR+/HER2- ductal breast cancer (BC); HR+/HER2- lobular breast cancer (BC); triple negative breast cancer (TNBC); colorectal cancer (CRC); soft tissue sarcoma (STS); radioligand imaging

Outcome Measures

Primary Outcomes (3)

• Part 1: Standard Uptake Value (SUV) of 68Ga-DFC413 uptake in organs and tumors over time

  Imaging properties of 68Ga-DFC413 will be evaluated by assessing radiotracer uptake, identified via positron emission tomography (PET) scans. The SUV values will be calculated and reported with summary statistics.

  Up to 240 minutes after 68Ga-DFC413 administration

• Part 1: Standard Uptake Value ratio (SUVr) of 68Ga-DFC413 uptake

  SUVr will be calculated by dividing the SUV of the lesions by the SUV of the different organs in order to identify the reference organ with the lowest uptake and the respective SUVr (i.e. using SUVmean or SUVmax).

  Up to 240 minutes after 68Ga-DFC413 administration

• Part 2: Agreement between 68Ga-DFC413 and 68Ga-NNS309 for assessing target lesions from both PET scans per disease group

  Agreement between target lesions and normal organs from 68Ga-DFC413 and 68Ga-NNS309 PET imaging will be assessed using summary statistics of SUV and SUVr.

  Up to 240 minutes after administration of each imaging agent

Secondary Outcomes (9)

• Part 1: Observed maximum concentration (Cmax) of 68Ga-DFC413 based on blood radioactivity data

  Up to 240 minutes after 68Ga-DFC413 administration

• Part 1: Time to reach maximum concentration (Tmax) of 68Ga-DFC413 based on blood radioactivity data

  Up to 240 minutes after 68Ga-DFC413 administration

• Part 1: Area under the concentration-time curve (AUC) of 68Ga-DFC413 based on blood radioactivity data

  Up to 240 minutes after 68Ga-DFC413 administration

• Part 1: Urinary excretion of 68Ga-DFC413

  Up to 240 minutes after 68Ga-DFC413 administration

• Part 1: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) of 68Ga-DFC413

  Up to 3 days after administration of each imaging agent

Study Arms (2)

Part 1: Imaging Characterization

EXPERIMENTAL

Single dose of 68Ga-DFC413

Drug: 68Ga-DFC413

Part 2: Comparative Assessment

EXPERIMENTAL

Single dose of 68Ga-DFC413 followed by 68Ga-NNS309; or single dose of 68Ga-NNS309 followed by 68Ga-DFC413

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

Interventions

68Ga-DFC413 DRUG

Radioimaging agent

Part 1: Imaging Characterization; Part 2: Comparative Assessment

68Ga-NNS309 DRUG

Radioimaging agent

Part 2: Comparative Assessment

Eligibility Criteria

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

You may qualify if:

• Signed informed consent must be obtained prior to participation in the study.
• Age ≥ 18 years old.
• ECOG performance status ≤ 2.
• Patients with one of the following indications (regardless of lines of prior therapy):
• Locally advanced unresectable or metastatic PDAC, NSCLC, HR+/HER2- ductal or lobular BC, TNBC, CRC or STS.
• Patients must have at least one measurable lesion per RECIST v1.1 as measured by local Investigator (by conventional MRI or CT scan).
• Patients must have an available archival tumor sample at the screening visit. If multiple archival tumor samples are available, the most recent will be requested. Exceptions may be made after documented discussion with Novartis.

You may not qualify if:

• Out-of-range laboratory values defined as:
• Estimated glomerular filtration rate \< 60 mL/min (calculated using CKD-EPI 2021 formula, or measured based on 24-hour urine collection)
• Total bilirubin \> 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin \> 3.0 x ULN) or direct bilirubin \> 1.5 x ULN
• Alanine aminotransferase (ALT) \> 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT \> 5.0 x ULN
• Aspartate aminotransferase (AST) \> 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if AST \> 5.0 x ULN
• Absolute Neutrophil Count \< 1.0 x 109/L
• Hemoglobin \< 9 g/dL
• Platelet count \< 75 x 109/L
• Known hypersensitivity to 68Ga-DFC413 or 68Ga-NNS309 or their excipients.
• Any serious uncontrolled infection (acute or chronic), such as, but not limited to, bacterial, viral or fungal infections, confirmed by clinical evidence, imaging, and/or relevant positive laboratory tests (e.g., blood cultures, PCR for DNA/RNA). If a serious infection develops, it must resolve or be adequately controlled prior to 68Ga-DFC413 and/or 68Ga-NNS309 initiation.
• Surgery or major invasive procedure within 4 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.
• Radiation therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.
• Change in anticancer therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.
• Radiological contrast administration within 48 hours prior to 68Ga-DFC413 or 68Ga-NNS309 administration.
• Initiation or increasing doses of corticosteroids, TGF-β signaling inhibitors or immunomodulators within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Chuo Ku, Tokyo, 1040045, Japan

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Neoplasms; 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): January 14, 2028
• Study Completion (Estimated): January 14, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)