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OncoMatch/Clinical Trials/NCT07150806

RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma

Is NCT07150806 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Actinium Ac 225 DOTATATE RYZ101 and L-lysine/L-arginine-containing Amino Acid for recurrent meningioma.

Phase 1/2RecruitingJoshua PalmerNCT07150806Data as of May 2026

Treatment: Actinium Ac 225 DOTATATE RYZ101 · L-lysine/L-arginine-containing Amino AcidThis phase I/II tests the safety, side effects, best dose and how well giving RYZ101 works for the treatment of patients with intracranial meningioma that is growing, spreading, or getting worse (progressive) or that has come back after a period of improvement (recurrent). RYZ101 is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Giving RYZ101 may be safe, tolerable and/or effective in treating patients with progressive or recurrent intracranial meningioma.

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Extracted eligibility criteria

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: surgery

progressed after first line treatment

Cannot have received: radiopharmaceutical therapy

Prior radiopharmaceutical therapies (RPT), including radioembolization

Cannot have received: solid organ or bone marrow transplantation

Prior solid organ or bone marrow transplantation

Lab requirements

Blood counts

Hemoglobin concentration ≥ 5.0 mmol/L (≥ 8.0 g/dL); ANC ≥ 1000 cells/µL; Platelets > 100 × 10^9/L

Kidney function

Creatinine clearance (CrCl) ≥ 60 mL/min calculated using CKD-EPI equation

Liver function

AST and ALT ≤ 2.5 × ULN (or ≤ 5 × ULN if presence of liver metastases); Total bilirubin ≤ 3 × ULN; Serum albumin ≥ 3.0 g/dL

Cardiac function

NYHA Class < II heart failure; LVEF ≥ 50%; No history of MI, ACS, or coronary intervention within 6 months; QTcF ≤ 470 ms; No resistant hypertension

Sufficient renal function, as evidenced by creatinine clearance (CrCl) ≥ 60 mL/min... Hemoglobin concentration ≥ 5.0 mmol/L (≥ 8.0 g/dL)... ANC ≥ 1000 cells/µL... Platelets > 100 × 10^9/L... AST and ALT ≤ 2.5 × ULN (or ≤ 5 × ULN if presence of liver metastases)... Total bilirubin ≤ 3 × ULN... Serum albumin ≥ 3.0 g/dL... Adequate coagulation function, defined by INR/PT and aPTT ≤ 1.5 × ULN, unless subject is receiving anticoagulant therapy and PT or aPTT is within therapeutic range of intended use of anticoagulants

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Ohio State University Comprehensive Cancer Center · Columbus, Ohio

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