^
    2d
    ACCEL: [Ac-225]-PSMA-62 Trial in Biochemically Recurrent and Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=48, Recruiting, POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    6d
    A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours (clinicaltrials.gov)
    P1, N=110, Recruiting, Fusion Pharmaceuticals Inc. | Initiation date: Feb 2024 --> Jun 2024
    Trial initiation date • Metastases
    15d
    Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC (clinicaltrials.gov)
    P1, N=31, Recruiting, RayzeBio, Inc. | Phase classification: P1b --> P1
    Phase classification • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • SSTR (Somatostatin Receptor)
    |
    SSTR positive
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • Actinium-225 DOTATATE (RYZ101)
    1m
    64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study) (clinicaltrials.gov)
    P1, N=14, Completed, Telix International Pty Ltd | Recruiting --> Completed | Trial completion date: Apr 2023 --> Jan 2024 | Trial primary completion date: Apr 2023 --> Dec 2023
    Trial completion • Trial completion date • Trial primary completion date
    |
    FOLH1 expression
    1m
    Targeted Alpha Particle Radiotherapy for Metastatic Uveal Melanoma (clinicaltrials.gov)
    P1, N=16, Recruiting, Modulation Therapeutics, Inc. | Trial primary completion date: Dec 2023 --> Apr 2025
    Trial primary completion date • Metastases
    2ms
    Actinium 225 Labeled Anti-CEA Antibody (Ac225-DOTA-M5A) for the Treatment of CEA Producing Advanced or Metastatic Cancers (clinicaltrials.gov)
    P1, N=20, Recruiting, City of Hope Medical Center | Trial completion date: Mar 2024 --> Aug 2025 | Trial primary completion date: Mar 2024 --> Aug 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    CEACAM5 positive
    2ms
    A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov)
    P1, N=111, Recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2025 --> Dec 2025 | Trial primary completion date: Mar 2025 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    JNJ-6420
    2ms
    225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome (clinicaltrials.gov)
    P1, N=15, Not yet recruiting, City of Hope Medical Center
    New P1 trial
    |
    Darzalex (daratumumab) • sirolimus • melphalan • fludarabine IV
    2ms
    Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer (clinicaltrials.gov)
    P1, N=60, Recruiting, Endocyte | Trial completion date: Mar 2026 --> Jan 2027 | Trial primary completion date: Mar 2026 --> Jan 2027
    Trial completion date • Trial primary completion date
    |
    abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • AAA817
    2ms
    Radioimmunotherapy (211At-OKT10-B10) and Chemotherapy (Melphalan) Before Stem Cell Transplantation for the Treatment of Multiple Myeloma (clinicaltrials.gov)
    P1, N=0, Withdrawn, Fred Hutchinson Cancer Center | N=30 --> 0 | Recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    CD34 (CD34 molecule)
    |
    melphalan • 211At-OKT10-B10
    3ms
    NCI-2022-03039: Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=15, Recruiting, City of Hope Medical Center | Suspended --> Recruiting
    Enrollment open
    |
    CD38 expression
    |
    Darzalex (daratumumab)
    3ms
    Targeted Alpha Therapy With 225Actinium-Prostate Specific Membrane Antigen (PSMA)-I&T of Castration-resISTant Prostate Cancer (TATCIST). (clinicaltrials.gov)
    P2, N=115, Recruiting, Fusion Pharmaceuticals Inc. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    MSI (Microsatellite instability) • BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    FPI-2265
    3ms
    Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer (clinicaltrials.gov)
    P1, N=60, Recruiting, Endocyte | Trial completion date: Oct 2025 --> Jan 2026 | Trial primary completion date: Oct 2025 --> Jan 2026
    Trial completion date • Trial primary completion date
    |
    abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • AAA817
    3ms
    A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours (clinicaltrials.gov)
    P1, N=110, Recruiting, Fusion Pharmaceuticals Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    3ms
    NCI-2022-03039: Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=15, Suspended, City of Hope Medical Center | Recruiting --> Suspended
    Trial suspension
    |
    CD38 expression
    |
    Darzalex (daratumumab)
    4ms
    Lintuzumab-Ac225 in Combination With Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=26, Active, not recruiting, Medical College of Wisconsin
    Trial completion date • Combination therapy
    |
    CD33 positive
    |
    cytarabine • mitoxantrone • Actimab-A (lintuzumab-Ac225) • Depocyte (liposomal cytarabine)
    4ms
    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 completion date • Trial primary completion date • Metastases
    |
    SSTR (Somatostatin Receptor)
    |
    Sutent (sunitinib) • everolimus • Actinium-225 DOTATATE (RYZ101) • Somatuline Depot (lanreotide prolonged-release subcutaneous) • Sandostatin LAR Depot (octreotide acetate)
    4ms
    A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours (clinicaltrials.gov)
    P1/2, N=6, Terminated, Fusion Pharmaceuticals Inc. | Completed --> Terminated; Fusion announced that it is discontinuing this study as part of a portfolio prioritization and assessment; Fusion no longer plans to pursue development of FPI-1966.
    Trial termination • Metastases
    |
    vofatamab (B-701) • FPI-1966
    4ms
    MED20-165: Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma (clinicaltrials.gov)
    P1, N=6, Recruiting, Memorial Sloan Kettering Cancer Center
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    131-I Apamistamab/CAR T-cell (Iomab-ACT)
    5ms
    131I-Apamistamab-Led Allogeneic Hematopoietic Cell Transplant for Patients with TP53 Mutated R/R AML Results in Significantly Improved Outcomes (TCT-ASTCT-CIBMTR 2024)
    Pts were randomized (1:1, N=153) to CC or Iomab-B with fludarabine and total body irradiation (2 Gy) followed by HCT (CC, n=77; Iomab-B, n=76). 131I-apamistamab led HCT significantly improves outcomes in pts with TP53 mutations, commensurate with rates observed in pts with wildtype TP53 in terms of CR, dCR and OS , overcoming the negative impact of this mutation. These data support the use of 131I-apamistamab led induction/conditioning and HCT in R/R AML, especially in patients with a TP53 mutation.
    Clinical
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 wild-type
    |
    fludarabine IV • Iomab-B (I-131-apamistamab)
    5ms
    A Safety Study of 212Pb-VMT-alpha-NET in Patients With Neuroendocrine Tumors (clinicaltrials.gov)
    P1, N=24, Recruiting, David Bushnell
    New P1 trial
    |
    212Pb-VMT-𝛼-NET
    5ms
    A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours (clinicaltrials.gov)
    P1, N=110, Not yet recruiting, Fusion Pharmaceuticals Inc.
    New P1 trial • Metastases
    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. | Phase classification: P1b --> P3
    Phase classification • Metastases
    |
    SSTR (Somatostatin Receptor)
    |
    Sutent (sunitinib) • everolimus • Actinium-225 DOTATATE (RYZ101) • Somatuline Depot (lanreotide prolonged-release subcutaneous) • Sandostatin LAR Depot (octreotide acetate)
    5ms
    Lintuzumab-Ac225 in Combination With Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=26, Active, not recruiting, Medical College of Wisconsin | Trial primary completion date: Oct 2024 --> May 2024
    Trial primary completion date • Combination therapy
    |
    CD33 positive
    |
    cytarabine • mitoxantrone • Actimab-A (lintuzumab-Ac225) • Depocyte (liposomal cytarabine)
    5ms
    PSMA PET Imaging Response Following a Single Dose 225AC J591 Therapy in Metastatic Castration Resistant Prostate Cancer: A Lesion and Patient Based Analysis (RSNA 2023)
    225Ac-PSMA-J591 effectively treats all metastatic categories. However, bone and visceral lesions may respond better than nodal lesions. Our findings need further validation but are informative for trial design and patient counselling.
    Clinical • Metastases
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    rosopatamab-225Ac (CONV01-α)
    5ms
    A Phase I/II, Open-label, Multi-center Study of [225Ac]Ac-PSMA-R2 in Men With PSMA-positive Prostate Cancer With or Without Prior 177Lu-PSMA Radioligand Therapy. (clinicaltrials.gov)
    P1/2, N=200, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    FOLH1 positive
    6ms
    A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov)
    P1, N=111, Recruiting, Janssen Research & Development, LLC | N=76 --> 111 | Trial completion date: Jul 2025 --> Oct 2025
    Enrollment change • Trial completion date • Metastases
    |
    JNJ-6420
    6ms
    131I-Apamistamab-Led Allogeneic Hematopoietic Cell Transplant Significantly Improves Overall Survival in Patients with TP53 Mutated R/R AML (ASH 2023)
    Pts were randomized (1:1) to CC or 131I-apamistamab with fludarabine and total body irradiation (2 Gy) followed by alloHCT. Pts with TP53 mutated R/R AML have a dismal prognosis and are seldom offered alloHCT due to high post-transplant relapse rates. 131I-apamistamab led alloHCT significantly improves survival outcomes in pts with TP53 mutations, commensurate with rates observed in pts with wildtype TP53, thereby overcoming the negative impact of this mutation. These data clearly support the use of 131I-apamistamab led induction and conditioning and alloHCT in R/R AML, including in patients with a TP53 mutation.
    Clinical
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 wild-type
    |
    fludarabine IV • Iomab-B (I-131-apamistamab)
    6ms
    Updated Results from Phase 1 Study of Targeted Radiotherapy with Lintuzumab-Ac225 in Combination with Venetoclax in Relapsed/Refractory AML (ASH 2023)
    The combination of lintuzumab-Ac225 and venetoclax had a manageable safety profile and no early mortality at day 30. The MTD was not reached and no significant toxicities have been reported during the follow-up period. Modified dosing schedule in Cohort 4 of the combination demonstrated improved anti-leukemic effects.
    P1 data • Combination therapy • IO biomarker
    |
    BCL2L1 (BCL2-like 1) • CD33 (CD33 Molecule)
    |
    BCL2 expression • MCL1 expression • CD33 positive
    |
    Venclexta (venetoclax) • Actimab-A (lintuzumab-Ac225)
    6ms
    7R01CA207645-03: Phase I Trial of 225Ac-J591 in Patients With mCRPC (clinicaltrials.gov)
    P1; Active, not recruiting --> Completed | Trial completion date: Jul 2024 --> Sep 2023
    Trial completion date • Trial completion • Metastases
    |
    CELLSEARCH®
    |
    rosopatamab-225Ac (CONV01-α)
    6ms
    Re-treatment 225Ac-J591 for mCRPC (clinicaltrials.gov)
    P1; Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    CELLSEARCH®
    |
    rosopatamab-225Ac (CONV01-α)
    6ms
    A Study of [225Ac]-FPI-1966 in Participants With Advanced Solid Tumours (clinicaltrials.gov)
    P1/2, N=6, Completed, Fusion Pharmaceuticals Inc. | Active, not recruiting --> Completed | Trial completion date: Dec 2026 --> Sep 2023 | Trial primary completion date: Jun 2026 --> Sep 2023
    Trial completion • Trial completion date • Trial primary completion date • Metastases
    |
    vofatamab (B-701) • FPI-1966
    6ms
    ALPHAMEDIX02: Targeted Alpha-emitter Therapy of PRRT Naïve and Previous PRRT Neuroendocrine Tumor Patients (clinicaltrials.gov)
    P2, N=68, Recruiting, Radiomedix, Inc. | N=34 --> 68 | Trial completion date: Dec 2023 --> Oct 2026 | Trial primary completion date: Dec 2022 --> Oct 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    SSTR (Somatostatin Receptor)
    |
    AlphaMedix (ORM-2110)
    6ms
    Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors (clinicaltrials.gov)
    P1, N=30, Recruiting, Orano Med LLC | N=50 --> 30
    Enrollment change • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    212Pb-DOTAM-GRPR1
    6ms
    A First in Human Study of BAY2701439 to Look at Safety, How the Body Absorbs, Distributes and Excretes the Drug, and How Well the Drug Works in Participants With Advanced Cancer Expressing the HER2 Protein (clinicaltrials.gov)
    P1, N=14, Completed, Bayer | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 underexpression
    |
    BAY2701439
    7ms
    A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov)
    P1, N=76, Recruiting, Janssen Research & Development, LLC | N=134 --> 76
    Enrollment change • Metastases
    |
    JNJ-6420
    7ms
    Phase 0/1 Study of 212Pb-NG001 in mCRPC (clinicaltrials.gov)
    P1, N=3, Completed, ARTBIO Inc. | Recruiting --> Completed | N=23 --> 3
    Trial completion • Enrollment change • Metastases
    |
    AB001
    7ms
    A First in Human Study of BAY2701439 to Look at Safety, How the Body Absorbs, Distributes and Excretes the Drug, and How Well the Drug Works in Participants With Advanced Cancer Expressing the HER2 Protein (clinicaltrials.gov)
    P1, N=14, Active, not recruiting, Bayer | Trial completion date: Apr 2024 --> Sep 2023 | Trial primary completion date: Mar 2024 --> Aug 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 underexpression
    |
    BAY2701439
    7ms
    Radioimmunotherapy (211At-OKT10-B10) and Chemotherapy (Melphalan) Before Stem Cell Transplantation for the Treatment of Multiple Myeloma (clinicaltrials.gov)
    P1, N=30, Recruiting, Fred Hutchinson Cancer Center | Withdrawn --> Recruiting | Trial completion date: Mar 2026 --> Sep 2027 | Trial primary completion date: Mar 2024 --> Oct 2025
    Enrollment open • Trial completion date • Trial primary completion date
    |
    CD34 (CD34 molecule)
    |
    melphalan • 211At-OKT10-B10
    8ms
    A targeted thorium-227 conjugate demonstrates efficacy in preclinical models of acquired drug resistance and combination potential with chemotherapeutics and antiangiogenic therapies. (PubMed, Mol Cancer Ther)
    In the MSLN-expressing ST206B ovarian cancer patient-derived xenograft model, MSLN-TTC accumulated specifically in the tumor, which combined with pegylated liposomal doxorubicin (Doxil), docetaxel, bevacizumab, or regorafenib treatment induced additive-to-synergistic antitumor efficacy and substantially increased response rates compared with respective monotherapies. The combination treatments were well tolerated and only transient decreases in white and red blood cells were observed. In summary, we demonstrate that MSLN-TTC treatment shows efficacy in p-gp-expressing models of chemoresistance and has combination potential with chemo- and antiangiogenic therapies.
    Preclinical • Journal
    |
    MSLN (Mesothelin)
    |
    MSLN expression
    |
    Avastin (bevacizumab) • Stivarga (regorafenib) • pegylated liposomal doxorubicin • thorium (227Th) anetumab corixetan (BAY 2287411)
    8ms
    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)
    P1b, N=288, Recruiting, RayzeBio, Inc. | N=218 --> 288
    Enrollment change • Metastases
    |
    SSTR (Somatostatin Receptor)
    |
    Sutent (sunitinib) • everolimus • Actinium-225 DOTATATE (RYZ101) • Somatuline Depot (lanreotide prolonged-release subcutaneous) • Sandostatin LAR Depot (octreotide acetate)