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Tests treatment safety and results for Neuroendocrine Neoplasm
Official title A Phase I Study to Assess the Safety and Efficacy of [225Ac]Ac-DOTATATE in Patients With SSTR+ GEP-Nens
ClinicalTrials.gov ID: NCT06732505
What this study is testing
What is [225Ac]Ac-DOTATATE?
[225Ac]Ac-DOTATATE is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuroendocrine neoplasm.
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
- This is a phase I study to assess the safety and efficacy of [225Ac]Ac-DOTATATE in patients with inoperable, locally advanced or metastatic, progressive, Well-Differentiatedwell differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine neoplasms with either no prior history of peptide receptor radionuclide therapy (PRRT naive) or prior history of peptide receptor radionuclide therapy (Previous PRRT).
- 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 to 80
You may be able to join if
- Patients must have the ability to understand and sign an approved informed consent form (ICF).
- Patients must be \>= 18 and \<＝80 years of age.
- Histopathologically confirmed G1 or G2 or G3 GEP-NET or GEP-NEC；
- Unresectable locally advanced or metastatic GEP-NET which confirmed by imaging examination.
- G1 or G2 NET patients: previously received fixed-dose Octreotide LAR (20-30 mg/3-4 weeks) for at least 12 weeks of continuous treatment with disease...
You likely can't join if
- Pregnant or lactating females.
- Received the following treatments within 4 weeks prior to initiation of study treatment, including but not limited to surgery (except biopsy)...
- Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to...
- Rapid progression with previous PRRT therapy.
- Any patient receiving treatment with short-acting Octreotide, which cannot be interrupted for 24 h before and 24 h after the administration of...
- Toxicity of prior antitumor therapy has not returned to ≤ grade 1 levels (except for alopecia).
See the full eligibility criteria
- Patients must have the ability to understand and sign an approved informed consent form (ICF).
- Patients must be \>= 18 and \<＝80 years of age.
- Histopathologically confirmed G1 or G2 or G3 GEP-NET or GEP-NEC；
- Unresectable locally advanced or metastatic GEP-NET which confirmed by imaging examination.
- G1 or G2 NET patients: previously received fixed-dose Octreotide LAR (20-30 mg/3-4 weeks) for at least 12 weeks of continuous treatment with disease progression;G3 NET orNEC patients: previously received at least 1 line...
- Presence of at least 1 measurable site of disease (based on RECIST 1.1).
- SSTR-PET positive.
- ECOG score of 0 or 1.
- Life expectancy of at least 12 weeks.
- Sufficient bone marrow capacity and organ function: Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 ml/min (Cockcroft Gault formula). Hemoglobin≥90g/L, neutrophil count ≥1.5×10\^9/L, platelets≥100×10\^9/L. Serum...
- people of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, IUDs, etc., during treatment and within 6 months of the last use of the trial...
- Pregnant or lactating females.
- Received the following treatments within 4 weeks prior to initiation of study treatment, including but not limited to surgery (except biopsy), radical radiotherapy, hepatic artery treatment embolization, cryoablation of...
- Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to initiation of study treatment.
- Rapid progression with previous PRRT therapy.
- Any patient receiving treatment with short-acting Octreotide, which cannot be interrupted for 24 h before and 24 h after the administration of initiation of study treatment, or any patient receiving treatment with...
- Toxicity of prior antitumor therapy has not returned to ≤ grade 1 levels (except for alopecia).
- Received external beam radiation therapy for bone metastases within 2 weeks prior to initiation of study treatment.
- Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrollment in the study.
- Uncontrolled congestive heart failure.
- uncontrolled diabetes mellitus, including baseline fasting glucose \> 2 x ULN.
- Known other malignancies (except for those without recurrence within 5 years after adequate treatment).
- Known hypersensitivity to Lutetium[177Lu] Oxodotreotide Injection or [225Ac]Ac-DOTATATE Injection and their excipients.
- Known to be unsuitable for enhanced CT or MRI contrast imaging due to allergic reaction or renal insufficiency.
- Any clinically significant active infection.
- Participated in other drug clinical trials within 4 weeks prior to initiation of study treatment and received treatment with the corresponding trial drug.
- Any other disease, mental status or surgical condition that is uncontrolled, may interfere with study completion (including poor compliance) or is inappropriate for the use of the investigational drug.
- Other treatment options (e.g., chemotherapy, targeted therapy) that, in the opinion of the investigator, are more appropriate for the patient than the treatment provided in the study based on the patient's disease...
- Unsuitable for the study for any reason, in the opinion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. 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.