Actively Recruiting
A Phase I Study to Assess the Safety and Efficacy of [225Ac]Ac-DOTATATE in Patients With SSTR+ GEP-Nens
Led by Peking University Cancer Hospital & Institute · Updated on 2025-06-26
36
Participants Needed
1
Research Sites
78 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
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).
CONDITIONS
Official 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...
- Able to understand and sign informed consent
- Age 18 to 80 years
- Histopathologically confirmed G1, G2, or G3 gastroenteropancreatic neuroendocrine tumors or neuroendocrine carcinoma
- Unresectable locally advanced or metastatic disease confirmed by imaging
- For G1 or G2 NET, prior treatment with fixed-dose Octreotide LAR for at least 12 weeks with disease progression
- For G3 NET or NEC, received at least one line of therapy with disease progression
- At least one measurable disease site based on RECIST 1.1
- Positive somatostatin receptor PET scan
- ECOG performance status 0 or 1
- Life expectancy of at least 12 weeks
- Adequate bone marrow and organ function including specific laboratory thresholds
- 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 lactating females
- Received surgery (except biopsy), radical radiotherapy, hepatic artery embolization, cryoablation, or radiofrequency ablation within 4 weeks before study treatment
- Received systemic antitumor therapy (targeted, immunotherapy, chemotherapy, herbal) within 4 weeks before study treatment
- Rapid progression after previous PRRT therapy
- Cannot interrupt short-acting Octreotide for 24 hours before and after treatment or Octreotide LAR for at least 6 weeks before treatment
- Toxicity from prior therapy not resolved to grade 1 or less (except alopecia)
- Received external beam radiation for bone metastases within 2 weeks before study treatment
- Known brain metastases unless treated and stable for at least 24 weeks
- Uncontrolled congestive heart failure
- Uncontrolled diabetes with fasting glucose > 2 times upper normal limit
- Other malignancies unless disease-free for at least 5 years after treatment
- Known allergy to Lutetium [177Lu] Oxodotreotide or [225Ac]Ac-DOTATATE or their components
- Unsuitable for enhanced CT or MRI contrast imaging
- Active significant infection
- Participation in other drug trials within 4 weeks before study treatment
- Any uncontrolled disease, mental status, or surgical condition interfering with study completion
- Investigator judgment that other treatments are more appropriate
- Any reason investigator deems unsuitable for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
Z
Zhi Yang
CONTACT
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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