^
10d
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
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • SSTR (Somatostatin Receptor)
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HER-2 negative
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Actinium-225 DOTATATE (RYZ101)
18d
Radium-223 in Biochemically Recurrent Prostate Cancer (clinicaltrials.gov)
P2, N=19, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2027 --> Jul 2026 | Trial primary completion date: Nov 2026 --> Feb 2026
Trial completion date • Trial primary completion date
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Xofigo (radium Ra-223 dichloride)
23d
Initial Clinical Experience with [177Lu]Lu-RTX-2358 Radiopharmaceutical Therapy Targeting Fibroblast Activation Protein: Biodistribution, Pharmacokinetics, and Dosimetry. (PubMed, J Nucl Med)
[177Lu]Lu-RTX-2358 demonstrated a manageable safety profile in a series of patients who were heavily pretreated for their disease. Given a promising therapeutic index as a result of prolonged retention in tumors and clearance from normal organs, further clinical evaluation is warranted.
PK/PD data • Journal
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FAP (Fibroblast activation protein, alpha)
1m
IRST185.04: Randomized, multicentre phase II trial of the sequencing of Radium-223 and Docetaxel plus prednisone in symptomatic bone-only metastatic castration-resistant prostate cancer (mCRPC) (2024-511660-89-00)
P1/2, N=70, Active, not recruiting, Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. | Recruiting --> Active, not recruiting
Enrollment closed
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docetaxel • prednisone • Xofigo (radium Ra-223 dichloride)
1m
New P1 trial • Tumor mutational burden • IO biomarker
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PD-L1 (Programmed death ligand 1) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • MGMT (6-O-methylguanine-DNA methyltransferase) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
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IDH wild-type • IDH1 R132
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Libtayo (cemiplimab-rwlc) • Actimab-A (lintuzumab-Ac225) • Zamyl (lintuzumab)
1m
Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study). (clinicaltrials.gov)
P1/2, N=100, Recruiting, AdvanCell Pty Limited | Trial completion date: Dec 2029 --> Jun 2029 | Trial primary completion date: Dec 2027 --> Jan 2029
Trial completion date • Trial primary completion date
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FOLH1 positive
1m
COMRADE: Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis (clinicaltrials.gov)
P1/2, N=145, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Apr 2026 --> Feb 2027 | Trial primary completion date: Apr 2026 --> Mar 2025
Trial completion date • Trial primary completion date • Tumor mutational burden
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CD4 (CD4 Molecule)
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Lynparza (olaparib) • Xofigo (radium Ra-223 dichloride)
1m
CR108817: A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer (clinicaltrials.gov)
P1, N=144, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Oct 2027 --> Jan 2027 | Trial primary completion date: Oct 2027 --> Jan 2027
Trial completion date • Trial primary completion date
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JNJ-6420 • pasritamig (JNJ-8343)
2ms
BAT-RAD: Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
P2, N=47, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Feb 2027 --> Feb 2029 | Trial primary completion date: Feb 2026 --> Feb 2028
Trial completion date • Trial primary completion date
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abiraterone acetate • Xofigo (radium Ra-223 dichloride)
2ms
AcTFirst: Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC (clinicaltrials.gov)
P3, N=940, Recruiting, Novartis Pharmaceuticals | Trial primary completion date: Feb 2028 --> Sep 2028
Trial primary completion date
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HRD (Homologous Recombination Deficiency)
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docetaxel • Xtandi (enzalutamide) • abiraterone acetate • cabazitaxel • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • 225Ac-vipivotide tetraxetan (AAA817)
2ms
Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 ) (clinicaltrials.gov)
P1/2, N=2, Terminated, Ariceum Therapeutics GmbH | N=50 --> 2 | Trial completion date: Dec 2026 --> Dec 2025 | Recruiting --> Terminated | Trial primary completion date: Aug 2026 --> Dec 2025; Study terminated due to strategic business decisions.
Enrollment change • Trial completion date • Trial termination • Trial primary completion date
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Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Zynyz (retifanlimab-dlwr) • SOMther (lutetium-177 DOTA satoreotide)
2ms
A Phase 0 Imaging Trial of [203Pb]Pb-VMT-α-NET to Enable Dosimetry and Treatment Planning for Refractory or Relapsed Metastatic Neuroendocrine Tumors with [212Pb]Pb-VMT-α-NET. (PubMed, J Nucl Med)
[203Pb]Pb-VMT-α-NET appears to be a safe and effective SPECT/CT tracer for imaging NETs larger than 1 cm and for normal organ and tumor radiation dosimetry. The chemically matched 203/212Pb theranostic pair offers the potential for a dosimetry-driven personalized treatment paradigm.
Journal
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SSTR (Somatostatin Receptor) • SSTR2 (Somatostatin Receptor 2)
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VMT-𝛼-NET