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

NCT07630961 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-07-28

No results posted yet for this study

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)

Interventions

DRUG

68Ga-DFC413

Radioimaging agent

DRUG

68Ga-NNS309

Radioimaging agent

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-23
Primary Completion
2028-01-16
Completion
2028-01-16
FDA Drug
Yes

Countries

  • Japan

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07630961 on ClinicalTrials.gov