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RayzeBio

HQ: San Diego, CA source · rayzebio.com ↗

Clinical Phase 3

Location: San Diego, CA · source · Oct 13, 2026

Profile checked Oct 10, 2026

Keywords: GEP-NET Gastroenteropancreatic Neuroendocrine Tumor Neuroendocrine Tumors Carcinoid Carcinoid Tumor Pancreatic NET Prostate Cancer (Adenocarcinoma) Adenocarcinoma of the Prostate Metastatic Castration-resistant Prostate Cancer Metastatic Hormone-Sensitive Prostate Cancer Biochemical Recurrence High-Risk Localized Prostate Cancer Metastatic Breast Cancer HER2-negative Breast Cancer ER+ Breast Cancer Advanced Breast Cancer Metastatic Breast Cancer With Bone Involvement ER-Positive HER2-Negative Breast Cancer Estrogen Receptor-positive Breast Cancer Hormone-sensitive Metastatic Breast Cancer Hormone-Sensitive Breast Cancer Metastatic Clear Cell Renal Cell Carcinoma Metastatic Urothelial Carcinoma Breast Cancer TNBC - Triple-Negative Breast Cancer Hormone Receptor Positive HER-2 Negative Breast Cancer NSCLC Hepatocellular Carcinoma Somatostatin Receptor SCLC,Extensive Stage RYZ101 RYZ711 RYZ801 RYZ401

8Trials (company is sponsor)

Timeline

  1. Trial start Phase 1/Phase 2: RYZ711 Diagnostic Platform Study source ↗
  2. Trial start Early phase 1: Imaging Study in Metastatic Clear Cell RCC. source ↗
  3. Trial start Early phase 1: Imaging Study in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC source ↗
  4. Trial start Phase 1: Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs. source ↗
  5. Trial start Phase 1/Phase 2: Study of the Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ (Glypican-3) Unresectable HCC source ↗
  6. Trial start Phase 1/Phase 2: Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs. source ↗
  7. Trial start Phase 1: Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC source ↗
  8. Trial start Phase 3: Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 8

RecordTitlePhaseStatusStartPrimary completion
NCT07862582RYZ711 Diagnostic Platform StudyPhase 1/Phase 2Not yet recruiting2026-102027-12 (estimated)
NCT06590857Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.Phase 1/Phase 2RecruitingJul 19, 20242028-10 (estimated)
NCT05477576Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA TherapyPhase 3Active, not recruitingMar 24, 20222026-12 (estimated)
NCT07671417Imaging Study in Metastatic Clear Cell RCC.Early phase 1RecruitingJun 15, 20262027-01 (estimated)
NCT07671092Imaging Study in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLCEarly phase 1RecruitingJun 15, 20262027-08 (estimated)
NCT06726161Study of the Theranostic Pair RYZ811 (Diagnostic) and RYZ801 (Therapeutic) to Identify and Treat Subjects With GPC3+ (Glypican-3) Unresectable HCCPhase 1/Phase 2RecruitingSep 5, 20252030-06 (estimated)
NCT07165132Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.Phase 1RecruitingDec 3, 20252027-02 (estimated)
NCT05595460Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLCPhase 1Active, not recruitingOct 10, 20222027-07 (estimated)

Raises and investors new

Form D raises come from the company’s own SEC filing (last 2 years).

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