OncoMatch/Clinical Trials/NCT06732505
A Phase I Study to Assess the Safety and Efficacy of [225Ac]Ac-DOTATATE in Patients With SSTR+ GEP-Nens
Is NCT06732505 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies [225Ac]Ac-DOTATATE for neuroendocrine neoplasm.
Treatment: [225Ac]Ac-DOTATATE — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Biomarker criteria
Required: SSTR positive by PET
SSTR-PET positive
Disease stage
Grade: g1g2g3
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: somatostatin analog (Octreotide LAR) — G1 or G2 NET patients: at least 12 weeks of continuous treatment with disease progression
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
Must have received: any antitumor therapy — G3 NET or NEC patients: at least 1 line therapy with disease progression
G3 NET or NEC patients: previously received at least 1 line therapy with disease progression
Cannot have received: surgery (except biopsy), radical radiotherapy, hepatic artery interventional embolization, cryoablation of liver metastases, or radiofrequency ablation
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 interventional embolization, cryoablation of liver metastases, or radiofrequency ablation
Cannot have received: systemic antitumor therapy (targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy)
Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to initiation of study treatment
Cannot have received: PRRT
Exception: rapid progression with previous PRRT therapy
Rapid progression with previous PRRT therapy
Cannot have received: short-acting Octreotide (Octreotide)
Exception: cannot be interrupted for 24 h before and 24 h after the administration of initiation of study treatment
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
Cannot have received: Octreotide LAR (Octreotide LAR)
Exception: cannot be interrupted for at least 6 weeks before the administration of initiation of study treatment
any patient receiving treatment with Octreotide LAR, which cannot be interrupted for at least 6 weeks before the administration of initiation of study treatment
Cannot have received: external beam radiation therapy for bone metastases
Received external beam radiation therapy for bone metastases within 2 weeks prior to initiation of study treatment
Lab requirements
Blood counts
Hemoglobin≥90g/L, neutrophil count ≥1.5×10^9/L, platelets≥100×10^9/L
Kidney function
Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 ml/min (Cockcroft Gault formula)
Liver function
Serum total bilirubin ≤1.5×ULN. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN, or ALT/AST≤5×ULN with liver metastases. Serum albumin ≥30g/L.
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 total bilirubin ≤1.5×ULN. Serum albumin ≥30g/L. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN，or ALT/AST≤5×ULN with liver metastases.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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