Pancreatic Ductal Adenocarcinoma (PDAC)Phase 1NCT05605522
A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours
A Phase 1 study testing [225]-FPI-2059 and [111In]-FPI-2058 in people with Pancreatic Ductal Adenocarcinoma (PDAC) and Squamous Cell Carcinoma of Head and Neck, run by 3B Pharmaceuticals GmbH at 8 sites in 2 countries.
Trial summary
This is a first-in-human Phase 1 clinical trial designed to investigate the safety, tolerability, pharmacokinetics, and biodistribution of [225Ac]-FPI-2059 and [111In]-FPI-2058 in participants with neurotensin receptor 1 (NTSR1)-expressing solid tumours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC), Squamous Cell Carcinoma of Head and Neck, Colorectal Cancer
- What is being tested?
- [225]-FPI-2059 and [111In]-FPI-2058
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 7 Feb 2023to 20 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed ICF prior to initiation of any study-specific procedures
- Histologically and/or cytologically confirmed solid tumor that is metastatic or locally advanced, inoperable, or recurrent. Solid tumors indications may include PDAC, CRC, NED prostate cancer, gastric cancer, SCCHN, and Ewing sarcoma.
- Disease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tolerable, or the patient refuses standard therapy
- Measurable disease per RECIST v.1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Sufficient target expression in at least one measurable lesion as determined by imaging following injection of [111In]-FPI-2058
- Adequate organ function
- Tumor tissue (either archival within the last 24 months or fresh biopsy)
Who cannot join
- Previous treatment with any radiopharmaceutical
- Contraindications to or inability to perform the imaging procedures required in this study
- Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents within certain amount of time prior to administration of the first dose of [111In]-FPI-2058
- Radiation therapy (RT) within 28 days prior to the first dose of [111In]-FPI-2058
- Patients with known CNS metastatic disease
- Concurrent severe and/or uncontrolled illness that would limit compliance with study requirements
- Known or suspected allergies or contraindication to the investigational treatment
- Received any type of vaccine within 30 days prior to the first dose of [111In]-FPI-2058
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
University of Alabama at Birmingham Hospital
Birmingham, Alabama, 35249
City of Hope Medical Center
Duarte, California, 91010
Advanced Molecular Imaging and Therapy
Glen Burnie, Maryland, 21061
University of Kentucky
Lexington, Kentucky, 40536
Hoag Family Cancer Institute
Newport Beach, California, 92663
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, 68130
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Phase 1 Study of [225Ac]-FPI-2059 in Adult Participants With NTSR1-Expressing Advanced, Metastatic and/or Recurrent Solid Tumours
This is a first-in-human Phase 1 clinical trial designed to investigate the safety, tolerability, pharmacokinetics, and biodistribution of [225Ac]-FPI-2059 and [111In]-FPI-2058 in participants with neurotensin receptor 1 (NTSR1)-expressing solid tumours.
Read the detailed description
This is a first-in-human, Phase 1, non-randomized, multi-centre, open-label clinical trial designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of [225Ac]-FPI-2059 and [111In]-FPI-2058, as well as the pharmacodynamics and preliminary anti-tumour activity of [225Ac]-FPI-2059 in participants with neurotensin receptor 1 (NTSR1)-expressing advanced, metastatic and/or recurrent solid tumours.
The study will employ a 3+3 dose escalation design to identify the recommended phase 2 dose (RP2D) and regimen of [225Ac]-FPI-2059 administered intravenously every 56 days.
After the RP2D for [225Ac]-FPI-2059 is determined, enrolment will continue into an expansion cohort, to confirm the safety and tolerability of the RP2D, as well as to identify any preliminary evidence of efficacy in selected NTSR1-expressing tumour types.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC), Squamous Cell Carcinoma of Head and Neck, Colorectal Cancer, Gastric Cancer, Ewing Sarcoma, NTSR1 Expressing Solid Tumours
- Being tested
- [225]-FPI-2059, [111In]-FPI-2058
- Keywords
- Solid Tumor, FPI-2059, FPI-2058, Pancreas, Prostate, Neuroendocrine, Stomach cancer, Gastric, Ewing sarcoma, HNSCC, Squamous cell carcinoma, CRC, Colorectal, actinium, targeted alpha therapy, radiopharmaceuticals
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Colorectal Neoplasms, Stomach Neoplasms, Sarcoma, Ewing, Prostatic Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[225]-FPI-2059Drug
[225Ac]-FPI-2059 is a targeted alpha therapeutic that consists of an NTSR1-targeting small molecule that is linked to Ac-225, an alpha particle emitting radionuclide. Participants will be dosed through IV administration every 56 days up to four cycles. The dose depends on cohort assignment.
In the Dose Expansion arm, [225Ac]-FPI-2059 will be administered at the RP2D as determined in Phase 1 Dose Escalation.
[111In]-FPI-2058Drug
[111In]-FPI-2058 is an imaging agent that consists of an NTSR1-targeting small molecule linked to In-111.Participants will receive [111In]-FPI-2058 by IV Injection for imaging once during screening period. The dose is consistent across cohorts.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Dose Escalation | Experimental | Not described Receives: Drug: [225]-FPI-2059; Drug: [111In]-FPI-2058 |
| Phase 1 Dose Expansion | Experimental | Not described Receives: Drug: [225]-FPI-2059; Drug: [111In]-FPI-2058 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events to evaluate safety and tolerability of [225Ac]-FPI-2059 and [111In]-FPI-2058
Measured: approximately 5 years post final administration
Maximum tolerated dose (MTD) of [225Ac]-FPI-2059
Measured: 56 days post administration
Radiation dose of [111In]-FPI-2058 and [225Ac]-FPI-2059 to whole body, organs, and selected regions of interest
Measured: within 56 days of administration
Secondary outcomes (3)
Anti-tumor activity of [225Ac]-FPI-2059 regimen measured by response per RECIST v1.1
Measured: approximately 5 years post final administration
Tumor uptake of [111In]-FPI-2058 by evaluating SPECT/CT and planar images
Measured: within 56 days of administration
Pharmacokinetics (PK) of [225Ac]-FPI-2059 and [111In]-FPI-2059 by measuring changes in clearance, AUC, Cmax, and half-life
Measured: approximately 36 days of final administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start7 Feb 2023
- Primary completion19 Jul 2024
- Study completion20 Feb 2025
Why it stopped: Sponsor reprioritization of active trials.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3B Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aaron Enke, Study director, 3B Pharmaceuticals GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605522
- Sponsor's protocol ID
- FPI-2059-101
- Status last verified
- Aug 2025
- First submitted
- 31 Oct 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of [225Ac]-FPI-2059 in Adult Participants With NTSR1-Expressing Advanced, Metastatic and/or Recurrent Solid Tumours
- ClinicalTrials.gov ID
- NCT05605522
- Acronym / sponsor ID
- FPI-2059-101
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC), Squamous Cell Carcinoma of Head and Neck, Colorectal Cancer, Gastric Cancer, Ewing Sarcoma, NTSR1 Expressing Solid Tumours
- Keywords
- Solid Tumor, FPI-2059, FPI-2058, Pancreas, Prostate, Neuroendocrine, Stomach cancer, Gastric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor reprioritization of active trials.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- 3B Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human Phase 1 clinical trial designed to investigate the safety, tolerability, pharmacokinetics, and biodistribution of [225Ac]-FPI-2059 and [111In]-FPI-2058 in participants with neurotensin receptor 1 (NTSR1)-expressing solid tumours.
Detailed description
This is a first-in-human, Phase 1, non-randomized, multi-centre, open-label clinical trial designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of [225Ac]-FPI-2059 and [111In]-FPI-2058, as well as the pharmacodynamics and preliminary anti-tumour activity of [225Ac]-FPI-2059 in participants with neurotensin receptor 1 (NTSR1)-expressing advanced, metastatic and/or recurrent solid tumours.
The study will employ a 3+3 dose escalation design to identify the recommended phase 2 dose (RP2D) and regimen of [225Ac]-FPI-2059 administered intravenously every 56 days.
After the RP2D for [225Ac]-FPI-2059 is determined, enrolment will continue into an expansion cohort, to confirm the safety and tolerability of the RP2D, as well as to identify any preliminary evidence of efficacy in selected NTSR1-expressing tumour types.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Dose Escalation | Experimental | Drug: [225]-FPI-2059, Drug: [111In]-FPI-2058 |
| Phase 1 Dose Expansion | Experimental | Drug: [225]-FPI-2059, Drug: [111In]-FPI-2058 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed ICF prior to initiation of any study-specific procedures
- Histologically and/or cytologically confirmed solid tumor that is metastatic or locally advanced, inoperable, or recurrent. Solid tumors indications may include PDAC, CRC, NED prostate cancer, gastric cancer, SCCHN, and Ewing sarcoma.
- Disease that has progressed despite prior treatment, and for which additional effective standard therapy is not available or is contraindicated, not tolerable, or the patient refuses standard therapy
- Measurable disease per RECIST v.1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (8 listed)
- Previous treatment with any radiopharmaceutical
- Contraindications to or inability to perform the imaging procedures required in this study
- Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents within certain amount of time prior to administration of the first dose of [111In]-FPI-2058
- Radiation therapy (RT) within 28 days prior to the first dose of [111In]-FPI-2058
- Patients with known CNS metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [225]-FPI-2059[225Ac]-FPI-2059 is a targeted alpha therapeutic that consists of an NTSR1-targeting small molecule that is linked to Ac-225, an alpha particle emitting radionuclide. Participants will be dosed through IV administration every 56 days up to four cycles. The dose depends on cohort assignment. In the Dose Expansion arm, [225Ac]-FPI-2059 will be administered at the RP2D as determined in Phase 1 Dose Escalation. | Drug | Phase 1 Dose Escalation, Phase 1 Dose Expansion |
| [111In]-FPI-2058[111In]-FPI-2058 is an imaging agent that consists of an NTSR1-targeting small molecule linked to In-111.Participants will receive [111In]-FPI-2058 by IV Injection for imaging once during screening period. The dose is consistent across cohorts. | Drug | Phase 1 Dose Escalation, Phase 1 Dose Expansion |
Primary outcome
Incidence of Adverse Events to evaluate safety and tolerability of [225Ac]-FPI-2059 and [111In]-FPI-2058
Time frame: approximately 5 years post final administration
Maximum tolerated dose (MTD) of [225Ac]-FPI-2059
Time frame: 56 days post administration
Radiation dose of [111In]-FPI-2058 and [225Ac]-FPI-2059 to whole body, organs, and selected regions of interest
Time frame: within 56 days of administration
3 secondary outcomes
Anti-tumor activity of [225Ac]-FPI-2059 regimen measured by response per RECIST v1.1
Time frame: approximately 5 years post final administration
Tumor uptake of [111In]-FPI-2058 by evaluating SPECT/CT and planar images
Time frame: within 56 days of administration
Pharmacokinetics (PK) of [225Ac]-FPI-2059 and [111In]-FPI-2059 by measuring changes in clearance, AUC, Cmax, and half-life
Time frame: approximately 36 days of final administration
Results and safety
The study was stopped early (reason given: Sponsor reprioritization of active trials.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
Related trials for Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 2
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC), G12D Mutated KRAS
RecruitingPhase 3
Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Enke study director
3B Pharmaceuticals GmbH
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [225]-FPI-2059 and [111In]-FPI-2058 in people with Pancreatic Ductal Adenocarcinoma (PDAC) and Squamous Cell Carcinoma of Head and Neck, run by 3B Pharmaceuticals GmbH at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor reprioritization of active trials.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events to evaluate safety and tolerability of [225Ac]-FPI-2059 and [111In]-FPI-2058 (time frame: approximately 5 years post final administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.