Metastatic Pancreatic Neuroendocrine TumorPhase 1NCT06663072
Study to Test the Combination of Fulvestrant With Lu-DOTATATE for Advanced Pancreatic Neuroendocrine Tumors
A Phase 1 study testing Fulvestrant and 177Lu-DOTATATE in people with Metastatic Pancreatic Neuroendocrine Tumor, run by University of Chicago at 1 site in United States.
Trial summary
This is a phase I, open-label study to assess the safety and preliminary efficacy of Fulvestrant in combination with 177Lu-DOTATATE for advanced pNETs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Neuroendocrine Tumor
- What is being tested?
- Fulvestrant and 177Lu-DOTATATE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2024to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Patients must have histologically confirmed pancreatic neuroendocrine tumor, WHO grades 1-2, Ki-67 index of \<20%.
- Patients must have locally advanced disease that is ineligible for curative-intent resection, or metastatic disease.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.
- Patients must also have tumors expressing somatostatin receptor, defined as radiotracer avid lesions as assessed by a previous DOTATATE PET scan.
- Patients must have radiographically progressed (as per RECIST v1.1 criteria) on one or more prior-lines of systemic therapy prior to enrollment in the trial. Prior systemic therapies include but are not limited to somatostatin analogs (octreotide LAR, lanreotide), Capecitabine/Temozolomide, tyrosine kinase inhibitors (e.g. everolimus), VEGF pathway inhibitors (e.g. sunitinib, cabozantinib), and/or other systemic chemotherapy.
- Patients should not have received any prior systemic therapy with peptide receptor radionuclide therapy (including 177Lu-DOTATATE) and/or Fulvestrant.
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- Prior treatment with hepatic intra-arterial embolic therapies is allowed if there is recovery from all toxicities, measurable lesions do not include embolized liver unless there has been clear subsequent progression, all measurable lesions are somatostatin receptor avid, and treatment completed at least 2 months prior to registration.
- Prior treatment with cryoablation or thermal/radiofrequency ablation of metastases is allowed if there is recovery from all toxicities, measurable lesions do not include treated metastases, and treatment completed at least 2 months prior to registration.
- Concomitant Medication: Concurrent SSA use while on protocol therapy is allowed provided that the patient: 1) has a functional tumor (evidence of peptide hormones and/or bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome), 2) has been on a stable dose of somatostatin analog therapy for at least three months, and 3) has previously demonstrated radiographic disease progression while on SSA therapy. There should be a minimum of 28 days between long-acting SSA and 177Lu-DOTATATE dosing. Short-acting SSAs should not be administered within 24 hours of 177Lu-DOTATATE dosing. Following lutetium 177Lu-DOTATATE dosing, long-acting SSAs may be administered between 4 and 24 hours after each dose.
- Age ≥18 years. As neuroendocrine tumors are very rare in children, patients <18 years of age will be excluded from this study. Furthermore, no reliable dosing or adverse event data are currently available on the use of Fulvestrant patients <18 years of age.
- ECOG performance status of 0 or 1.
- Patients must have adequate organ and marrow function as defined below:
- Absolute Neutrophil Count ≥1,500/µL
- Platelet Count ≥100,000/µL
- Hemoglobin ≥ 9g/dL
- Creatinine <1.5 mg/dL
- -OR-
- Creatinine Clearance ≥ 50 mL/min (Cockroft- Gault calculated)
- Total bilirubin ≤ 1.5 × institutional upper limit of normal
- AST AND ALT ≤ 3 × institutional upper limit of normal
- Serum Albumin ≥ 3.0 g/dL
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Patients should not have any other active malignancies at the time of study enrollment or a history of myelodysplastic syndromes/acute myeloid leukemia accounting for the rare but serious bone-marrow toxicity of 177Lu-DOTATATE. Patients with a remote history of other malignancies may be eligible for enrollment if the malignancy was curable, they have completed all curative-intent treatment (such as surgery, radiation and adjuvant therapy if warranted), and the malignancy has not recurred after 3 years of initial diagnosis.
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 3 months.
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
- Not pregnant and not nursing since the effects of 177Lu-DOTATATE on the developing human fetus are not well-established. For women of childbearing potential only, a negative pregnancy test done ≤ 28 days prior to registration is required.
- Patients must have a life expectancy of >12 weeks.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who are unable to provide or understand written informed consent and comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.
- Patients who are receiving any other investigational agents.
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
- Pregnant or breastfeeding.
- Clinical or laboratory signs of imminent organ failure, as determined by the treating investigator.
- Patients with known untreated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
Clinical Trials Intake, 1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Chih-Yi Liao
About this study
Official title: A Phase I Study of Fulvestrant in Combination With Lu-DOTATATE for Advanced Pancreatic Neuroendocrine Tumors
This is a phase I, open-label study to assess the safety and preliminary efficacy of Fulvestrant in combination with 177Lu-DOTATATE for advanced pNETs.
Read the detailed description
Patients with metastatic pancreatic neuroendocrine tumors (pNETs) suffer from a diminished lifespan. Newer therapies such as Peptide Receptor Radionuclide Therapy (PRRT), using 177Lu-DOTATATE, have aimed to improve survival in metastatic NETs, but result in palliation rather than cure. Combining radioligand therapies (RLT) with radiosensitizers has not been widely explored in the clinical setting, but encouraging pre-clinical data makes this a sensible approach.
In this study the investigators will assess the safety combining 177Lu-DOTATATE in combination with Fulvestrant in patients with pancreatic tumors. The investigators will also seek to learn on how well people respond to the combination by measuring changes in tumor size.
- Being tested
- Fulvestrant, 177Lu-DOTATATE
- Medical subject headings
- Adenoma, Islet Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
Safety-Run In: Starting Dose: 500 mg IM on Days 1, 15, and 29 of Cycle 1; followed by 500 mg IM on Days 1 and 29 of every cycle thereafter for a total of 9 doses.
Dose Expansion: 500 mg IM: Days 1, 15, and 29 of Cycle 1; followed by 500 mg IM on Days 1 and 29 of every cycle thereafter for a total of 9 doses.
177Lu-DOTATATEDrug
Safety-Run In: Starting Dose: 7.4 GBq (200 mCi) IV every 8 weeks for a total of 4 Cycles
Dose Expansion:177Lu-DOTATATE7.4 GBq (200 mCi) IV or 3.7 GBq (100 mCi) IV: IV dose every 8 weeks for a total of 4 Cycles.
| Study group | Role | What they receive |
|---|---|---|
| Safety-Run In | Experimental | Safety and tolerability data of the combination treatment from the first 6 patients who complete at least 28 days of safety follow-up after the first dose of combination treatment. If no significant safety issues are identified the study will proceed to Arm 2 (dose expansion). Receives: Drug: Fulvestrant; Drug: 177Lu-DOTATATE |
| Dose-Expansion | Experimental | Stage 2 will enroll an additional 13 patients for dose expansion. Fulvestrant and 177Lu-DOTATATE will be given at doses 500 mg IM and 7.4 GBq (200 mCi) IV or 3.7 GBq (100 mCi) IV. Receives: Drug: Fulvestrant; Drug: 177Lu-DOTATATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The rates of tumor response categories (CR, PR, SD, PD, Not Evaluated, Too Early) will be summarized and compared to historical control of response to PRRT treatment.
Measured: Through study completion, an average of 2 years
Safety
Safety will be measured by the incidence of adverse events and serious adverse events.
Measured: 8 months for duration of the treatment (until the post-treatment safety follow-up visit)
Secondary outcomes (4)
Progression Free Survival
Time from registration to either disease progression or death.
Measured: Through study completion, an average of 2 years
Progression Free Survival
Time from registration to either disease progression or death after 12 months
Measured: 12 months
Overall Survival
Time from registration to death.
Measured: Through study completion, an average of 2 years
Overall Survival
Time from registration to death after 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start13 Dec 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Model description
- This is a phase I, open-label study to assess the safety and preliminary efficacy of Fulvestrant in combination with 177Lu-DOTATATE for advanced pNETs. It will involve two stages: Stage 1, a safety run-in stage (enrolling 6-12 patients), and Stage 2, a dose-expansion stage (enrolling 13 patients).
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih-Yi (Andy) Liao, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663072
- Sponsor's protocol ID
- IRB24-1395
- Status last verified
- Jan 2026
- First submitted
- 22 Oct 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Fulvestrant in Combination With Lu-DOTATATE for Advanced Pancreatic Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT06663072
- Acronym / sponsor ID
- IRB24-1395
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 Oct 2024 (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 phase I, open-label study to assess the safety and preliminary efficacy of Fulvestrant in combination with 177Lu-DOTATATE for advanced pNETs.
Detailed description
Patients with metastatic pancreatic neuroendocrine tumors (pNETs) suffer from a diminished lifespan. Newer therapies such as Peptide Receptor Radionuclide Therapy (PRRT), using 177Lu-DOTATATE, have aimed to improve survival in metastatic NETs, but result in palliation rather than cure. Combining radioligand therapies (RLT) with radiosensitizers has not been widely explored in the clinical setting, but encouraging pre-clinical data makes this a sensible approach.
In this study the investigators will assess the safety combining 177Lu-DOTATATE in combination with Fulvestrant in patients with pancreatic tumors. The investigators will also seek to learn on how well people respond to the combination by measuring changes in tumor size.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a phase I, open-label study to assess the safety and preliminary efficacy of Fulvestrant in combination with 177Lu-DOTATATE for advanced pNETs. It will involve two stages: Stage 1, a safety run-in stage (enrolling 6-12 patients), and Stage 2, a dose-expansion stage (enrolling 13 patients).
| Arm | Type | Receives |
|---|---|---|
| Safety-Run In | Experimental | Drug: Fulvestrant, Drug: 177Lu-DOTATATESafety and tolerability data of the combination treatment from the first 6 patients who complete at least 28 days of safety follow-up after the first dose of combination treatment. If no significant safety issues are identified the study will proceed to Arm 2 (dose expansion). |
| Dose-Expansion | Experimental | Drug: Fulvestrant, Drug: 177Lu-DOTATATEStage 2 will enroll an additional 13 patients for dose expansion. Fulvestrant and 177Lu-DOTATATE will be given at doses 500 mg IM and 7.4 GBq (200 mCi) IV or 3.7 GBq (100 mCi) IV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Patients must have histologically confirmed pancreatic neuroendocrine tumor, WHO grades 1-2, Ki-67 index of \<20%.
- Patients must have locally advanced disease that is ineligible for curative-intent resection, or metastatic disease.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.
- Patients must also have tumors expressing somatostatin receptor, defined as radiotracer avid lesions as assessed by a previous DOTATATE PET scan.
- Patients must have radiographically progressed (as per RECIST v1.1 criteria) on one or more prior-lines of systemic therapy prior to enrollment in the trial. Prior systemic therapies include but are not limited to somatostatin analogs (octreotide LAR, lanreotide), Capecitabine/Temozolomide, tyrosine kinase inhibitors (e.g. everolimus), VEGF pathway inhibitors (e.g. sunitinib, cabozantinib), and/or other systemic chemotherapy.
Key exclusion criteria (6 listed)
- Patients who are unable to provide or understand written informed consent and comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.
- Patients who are receiving any other investigational agents.
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 3 years.
- Pregnant or breastfeeding.
- Clinical or laboratory signs of imminent organ failure, as determined by the treating investigator.
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 |
|---|---|---|
| FulvestrantSafety-Run In: Starting Dose: 500 mg IM on Days 1, 15, and 29 of Cycle 1; followed by 500 mg IM on Days 1 and 29 of every cycle thereafter for a total of 9 doses. Dose Expansion: 500 mg IM: Days 1, 15, and 29 of Cycle 1; followed by 500 mg IM on Days 1 and 29 of every cycle thereafter for a total of 9 doses. | Drug | Dose-Expansion, Safety-Run In |
| 177Lu-DOTATATESafety-Run In: Starting Dose: 7.4 GBq (200 mCi) IV every 8 weeks for a total of 4 Cycles Dose Expansion:177Lu-DOTATATE7.4 GBq (200 mCi) IV or 3.7 GBq (100 mCi) IV: IV dose every 8 weeks for a total of 4 Cycles. | Drug | Dose-Expansion, Safety-Run In |
Primary outcome
Objective Response Rate (ORR)
Time frame: Through study completion, an average of 2 years
The rates of tumor response categories (CR, PR, SD, PD, Not Evaluated, Too Early) will be summarized and compared to historical control of response to PRRT treatment.
Safety
Time frame: 8 months for duration of the treatment (until the post-treatment safety follow-up visit)
Safety will be measured by the incidence of adverse events and serious adverse events.
4 secondary outcomes
Progression Free Survival
Time frame: Through study completion, an average of 2 years
Progression Free Survival
Time frame: 12 months
Overall Survival
Time frame: Through study completion, an average of 2 years
Overall Survival
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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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.
Chih-Yi (Andy) Liao, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fulvestrant and 177Lu-DOTATATE in people with Metastatic Pancreatic Neuroendocrine Tumor, run by University of Chicago at 1 site in United States.
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 30 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Intake (855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Through study completion, an average of 2 years). The study lists 2 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 9 Jan 2026.