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OncoMatch/Clinical Trials/NCT07150806

RYZ101 for the Treatment of Progressive or Recurrent Intracranial Meningioma

Is NCT07150806 recruiting? Yes, currently enrolling (Sep 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 Sep 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

Treatments studied

Radioligand therapy

Actinium Ac 225 DOTATATE RYZ101

Other

L-lysine/L-arginine-containing Amino Acid

Cancer type

Meningioma

Biomarker criteria

Required: SSTR2 positive

68Ga-DOTATATE positive recurrent or progressive meningiomas

Performance status

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

Prior therapy

Cannot have received: alpha radiopharmaceutical therapies (RPT), including radioembolization

Prior alpha radiopharmaceutical therapies (RPT), including radioembolization

Lab requirements

Blood counts

Hemoglobin ≥ 8.0 g/dL; ANC ≥ 1000 cells/µL; Platelets > 100 × 10^9/L; Adequate coagulation function (INR/PT and aPTT ≤ 1.5 × ULN unless on anticoagulant therapy and within therapeutic range)

Kidney function

Creatinine clearance (CrCl) ≥ 60 mL/min or eGFR ≥60 mL/min/1.73m2 (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/angioplasty/stenting/bypass within 6 months; QTcF ≤ 470 ms (average of 3 ECGs); No resistant hypertension (BP ≤ 140/90 mmHg on optimal therapy)

Sufficient renal function, as evidenced by creatinine clearance (CrCl) ≥ 60 mL/min or eGFR ≥60 mL/min/1.73m2 ... Hemoglobin ≥ 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 ... NYHA Class < II heart failure ... LVEF ≥ 50% ... No history of MI/ACS/angioplasty/stenting/bypass within 6 months ... QTcF ≤ 470 ms ... No resistant hypertension (BP ≤ 140/90 mmHg on optimal therapy)

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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Frequently asked questions

Is NCT07150806 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior alpha radiopharmaceutical therapies (RPT), including radioembolization disqualifies patients from enrollment.

Does this trial require SSTR2?

Yes, SSTR2 positive is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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Related pages

Meningioma trials