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    DRUG:

    Actinium-225 DOTATATE (RYZ101)

    i
    Other names: RYZ101, Actinium 225 radiolabeled somatostatin analog, 225Ac-DOTATATE, RYZ 101, RYZ-101
    Company:
    BMS, RayzeBio
    Drug class:
    Alpha radiation emitter, SSTR2 modulator
    Related drugs:
    6d
    Dosimetry Results from the Phase 1b/3 ACTION-1 Trial of [225Ac]Ac-DOTATATE (RYZ101) in Patients with Somatostatin Receptor-Expressing, Well-Differentiated GEP-NETs. (PubMed, J Nucl Med)
    The 213Bi daughter mostly remained with DOTATATE in tumors, decaying at the same location as 221Fr. The favorable tumor-to-normal tissue absorbed dose ratio of [225Ac]Ac-DOTATATE supports its use in patients with SSTR-expressing GEP-NETs.
    P1 data • Journal
    |
    SSTR (Somatostatin Receptor) • SSTR2 (Somatostatin Receptor 2)
    |
    Actinium-225 DOTATATE (RYZ101)
    2ms
    RYZ101-101: Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC (clinicaltrials.gov)
    P1, N=21, Active, not recruiting, RayzeBio, Inc. | N=49 --> 21 | Trial completion date: Mar 2029 --> Jul 2027 | Recruiting --> Active, not recruiting
    Enrollment closed • Enrollment change • Trial completion date
    |
    PD-L1 (Programmed death ligand 1) • SSTR (Somatostatin Receptor)
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • Actinium-225 DOTATATE (RYZ101)
    2ms
    ACTION-1: Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy (clinicaltrials.gov)
    P3, N=338, Recruiting, RayzeBio, Inc. | Trial completion date: Jul 2028 --> Dec 2030
    Trial completion date
    |
    SSTR (Somatostatin Receptor)
    |
    sunitinib • everolimus • Actinium-225 DOTATATE (RYZ101)
    3ms
    TRACY-1: Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs. (clinicaltrials.gov)
    P1/2, N=16, Active, not recruiting, RayzeBio, Inc. | Recruiting --> Active, not recruiting | N=124 --> 16
    Enrollment closed • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • SSTR (Somatostatin Receptor)
    |
    HER-2 negative
    |
    Actinium-225 DOTATATE (RYZ101)
    5ms
    ACTION-1: Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy (clinicaltrials.gov)
    P3, N=288, Recruiting, RayzeBio, Inc. | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial primary completion date
    |
    SSTR (Somatostatin Receptor)
    |
    sunitinib • everolimus • Actinium-225 DOTATATE (RYZ101)
    1year
    Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC (clinicaltrials.gov)
    P1, N=49, Recruiting, RayzeBio, Inc. | N=31 --> 49 | Trial primary completion date: Mar 2027 --> Jun 2027
    Enrollment change • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • SSTR (Somatostatin Receptor)
    |
    SSTR positive
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • Actinium-225 DOTATATE (RYZ101)
    1year
    Study of RYZ101 in Combination with SoC in Subjects with SSTR+ ES-SCLC (clinicaltrials.gov)
    P1, N=31, Recruiting, RayzeBio, Inc. | Trial completion date: Dec 2026 --> Mar 2029 | Trial primary completion date: Mar 2025 --> Mar 2027
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • SSTR (Somatostatin Receptor)
    |
    SSTR positive
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • Actinium-225 DOTATATE (RYZ101)
    over1year
    AcTRESS: A Phase I Study to Assess the Tolerability of 225Ac-DOTATATE in Patients with Refractory and Relapsing Multiple Myeloma Expressing Somatostatin Receptors (clinicaltrials.gov)
    P1, N=0, Withdrawn, Jules Bordet Institute | N=30 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    Actinium-225 DOTATATE (RYZ101)
    over1year
    ACTION-1: Study of RYZ101 Compared with SOC in Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy (clinicaltrials.gov)
    P3, N=288, Recruiting, RayzeBio, Inc. | Trial primary completion date: Jul 2025 --> Dec 2025
    Trial primary completion date
    |
    SSTR (Somatostatin Receptor)
    |
    sunitinib • everolimus • Actinium-225 DOTATATE (RYZ101)
    over1year
    TRACY-1: Trial of 225Ac-DOTATATE (RYZ101) in Subjects with ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs. (clinicaltrials.gov)
    P1/2, N=124, Recruiting, RayzeBio, Inc. | Trial completion date: Jul 2029 --> Jan 2033 | Trial primary completion date: May 2028 --> Oct 2028
    Trial completion date • Trial primary completion date
    |
    Actinium-225 DOTATATE (RYZ101)
    over1year
    TRACY-1: Trial of 225Ac-DOTATATE (RYZ101) Alone and with Pembrolizumab in Subjects with ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs (clinicaltrials.gov)
    P1/2, N=172, Recruiting, RayzeBio, Inc.
    New P1/2 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Actinium-225 DOTATATE (RYZ101)
    almost2years
    ACTION-1: Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy (clinicaltrials.gov)
    P3, N=288, Recruiting, RayzeBio, Inc. | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    SSTR (Somatostatin Receptor)
    |
    sunitinib • everolimus • Actinium-225 DOTATATE (RYZ101)