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New treatment option for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Official title Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT07630961
What this study is testing
What is 68Ga-DFC413?
68Ga-DFC413 is an investigational medicine, being studied as a potential treatment for metastatic pancreatic ductal adenocarcinoma (pdac).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients eligible for inclusion in this study must meet all of the following criteria:
- 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...
You likely can't join if
- Patients meeting any of the following criteria are not eligible for inclusion in this study:
- 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 \>...
- 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
See the full eligibility criteria
Who can join
- Patients eligible for inclusion in this study must meet all of the following criteria:
- 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...
What rules you out
- Patients meeting any of the following criteria are not eligible for inclusion in this study:
- 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
- Unmanageable urinary tract obstruction or urinary incontinence. If ureteral obstruction can be managed with the placement of ureteral stents, this exclusion criterion does not apply.
- 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...
- 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.
- Known additional malignancy that is progressing or requires active treatment.
- Inability to complete the required investigational and standard imaging examinations due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time).
- Presence of CTCAE version 5.0 ≥ Grade 2 toxicity due to prior cancer therapy, except for neuropathy (inclusion of patients with neuropathy of ≤ Grade 2 is permitted) and alopecia.
- Any medical condition that would, in the Investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures (including radiation safety...
- Pregnant women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
- Nursing (breast-feeding) women. Women who do not breast feed for 12 hours after 68Ga-DFC413 and/or 68Ga-NNS309 administration, but express and discard breast milk, are eligible.
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they use highly effective methods of contraception (failure rate \<1% per year) for 12 hours after the...
- Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not...
- Bilateral tubal ligation, female sterilization (have had bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking 68Ga-DFC413 or 68Ga-NNS309...
- Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient.
- Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that...
- Sexually active males unwilling to use a condom during intercourse for 12 hours after the administered radioactive dose of 68Ga-DFC413 and 68Ga-NNS309. A condom is required for all sexually active male patients to...
The study team makes the final eligibility decision.
Where it's taking place
- Chuo Ku, Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chuo Ku, Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.