Actively Recruiting
A Phase I Study to Assess the Safety and Efficacy of [225Ac]Ac-DOTATATE in Patients With Inoperable, Locally Advanced or Metastatic, Progressive, Well-Differentiated, Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Neoplasms
Led by Peking University Cancer Hospital & Institute · Updated on 2025-06-26
36
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
P
Peking University Cancer Hospital & Institute
Lead Sponsor
S
Sinotau Pharmaceutical Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and efficacy of [225Ac]Ac-DOTATATE in adults with inoperable, locally advanced or metastatic, progressive, well-differentiated, somatostatin receptor-positive gastroenteropancreatic neuroendocrine neoplasms. This phase I study includes patients who are either new to peptide receptor radionuclide therapy (PRRT) or have previously received it. The study aims to find a suitable dose and understand the treatment's tolerability. Participants receive [225Ac]Ac-DOTATATE infusions every 8 weeks for up to four cycles. The dose escalation phase has two groups: one with patients who had prior 177Lu-PRRT treatment and one without. Dose levels range from 90 kBq/kg to 120 kBq/kg per cycle. Following this, a dose expansion phase groups patients based on their Ki-67 index, a marker of tumor growth. During the study, participants undergo regular assessments including imaging to measure tumor sites, blood tests to monitor organ function and bone marrow capacity, and evaluations of symptoms and side effects. Researchers will measure safety and tolerability up to 32 weeks after the first infusion and determine the recommended dose within 56 days. Additionally, tumor response and disease progression will be tracked for up to 24 months after the last dose. Participants are monitored closely throughout to ensure safety and collect detailed data on treatment effects.
CONDITIONS
Brief Title
A Phase I Study to Assess the Safety and Efficacy of [225Ac]Ac-DOTATATE in Patients With SSTR+ GEP-Nens
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent
- Age 18 to 80 years
- Histopathologically confirmed G1, G2, or G3 gastroenteropancreatic neuroendocrine tumor or carcinoma
- Unresectable locally advanced or metastatic disease confirmed by imaging
- For G1 or G2 NET patients: prior fixed-dose Octreotide LAR treatment for at least 12 weeks with disease progression
- For G3 NET or NEC patients: prior at least one line of therapy with disease progression
- At least one measurable site of disease by RECIST 1.1
- Positive somatostatin receptor PET scan
- ECOG performance status score of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate bone marrow and organ function including specified blood counts and liver and kidney function
- Use of effective contraception during treatment and for 6 months after last dose if of childbearing potential
You will not qualify if you...
- Pregnant or breastfeeding women
- Recent surgery, radical radiotherapy, hepatic artery embolization, cryoablation, or radiofrequency ablation within 4 weeks prior to study treatment
- Systemic antitumor therapy including targeted therapy, immunotherapy, chemotherapy within 4 weeks prior to study treatment
- Rapid progression following prior PRRT therapy
- Use of short-acting Octreotide not interruptible around study treatment or Octreotide LAR not interruptible for at least 6 weeks prior to treatment
- Unresolved toxicity from prior antitumor therapy above grade 1 (except alopecia)
- External beam radiation for bone metastases within 2 weeks prior to study treatment
- Known brain metastases unless treated and stable for at least 24 weeks
- Uncontrolled congestive heart failure
- Uncontrolled diabetes including fasting glucose over twice the upper limit of normal
- Other malignancies except those without recurrence within 5 years after treatment
- Known hypersensitivity to study drugs or their components
- Unsuitability for enhanced CT or MRI contrast due to allergy or kidney problems
- Active significant infection
- Participation in other drug trials within 4 weeks prior to study treatment
- Other uncontrolled diseases, mental status, or surgical conditions that may interfere with study completion
- Investigator's judgment that other treatments are more appropriate
- Any other reason making the participant unsuitable for the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 32 weeks
Participants receive one infusion of [225Ac]Ac-DOTATATE every 8 weeks for up to 4 cycles.
Up to 4 visits every 8 weeks (in-person)
Duration - Up to 24 months
Participants are monitored for safety, efficacy, and disease progression after treatment completion.
Visits scheduled periodically over 24 months (in-person)
Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
Z
Zhi Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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