^
2d
Evaluation of ATO-101™ in Patients With Non-Muscle-Invasive Bladder Cancer (PERSEVERANCE EU) (clinicaltrials.gov)
P1, N=24, Not yet recruiting, Institut Cancerologie de l'Ouest | Trial completion date: Aug 2028 --> Jan 2030 | Initiation date: Feb 2026 --> Jan 2027 | Trial primary completion date: Aug 2027 --> Jan 2029
Trial completion date • Trial initiation date • Trial primary completion date • First-in-human
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Rencarex (girentuximab)
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
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SSTR (Somatostatin Receptor) • SSTR2 (Somatostatin Receptor 2)
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Actinium-225 DOTATATE (RYZ101)
9d
Rad2Nivo: Study of Nivolumab in Combination w Radium-223 in Men w Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
P1, N=39, Active, not recruiting, University of Utah | Trial completion date: Apr 2026 --> Dec 2026 | Trial primary completion date: Feb 2025 --> Apr 2026
Trial completion date • Trial primary completion date • Tumor mutational burden
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Opdivo (nivolumab) • Xofigo (radium Ra-223 dichloride)
13d
New P3 trial
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FOLH1 positive
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enzalutamide • abiraterone acetate • Nubeqa (darolutamide) • cabazitaxel • apalutamide • Xofigo (radium Ra-223 dichloride) • AiRuiEn (rezvilutamide) • FPI-2265 • prednisolone
15d
ProTACT: Study With [225Ac]Ac-FL-020 in mCRPC Participants (clinicaltrials.gov)
P1, N=50, Recruiting, Full-Life Technologies GmbH | Trial completion date: Dec 2026 --> Sep 2027 | Trial primary completion date: Jun 2026 --> Oct 2026
Trial completion date • Trial primary completion date • First-in-human
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225Ac-FL-020
26d
New P1/2 trial
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FOLH1 positive
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docetaxel • AZD9574 • FPI-2265
29d
Enrollment change • First-in-human
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • BRCA (Breast cancer early onset) • STEAP1 (STEAP Family Member 1)
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MSI-H/dMMR • BRCA mutation
1m
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov)
P2, N=85, Active, not recruiting, Fusion Pharmaceuticals Inc. | Trial completion date: Aug 2030 --> May 2027 | Trial primary completion date: Jan 2030 --> May 2027
Trial completion date • Trial primary completion date
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BRCA (Breast cancer early onset)
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BRCA mutation • FOLH1 positive
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Lynparza (olaparib) • FPI-2265
1m
NCI-2018-01788: 211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov)
P1/2, N=30, Recruiting, Fred Hutchinson Cancer Center | Trial completion date: Mar 2029 --> Oct 2029 | Trial primary completion date: Jun 2027 --> Jan 2028
Trial completion date • Trial primary completion date
|
HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B)
|
cyclophosphamide • fludarabine IV • Iomab-B (I-131-apamistamab)
1m
Preclinical Evaluation of Radium-223 and Immune Checkpoint Inhibitors Using an Immune-Competent Model of Prostate Cancer Bone Metastases. (PubMed, Precis Oncol)
223RaCl2 localizes primarily to bone surfaces, limiting direct cytotoxic and immunomodulatory effects within the tumor microenvironment. While combination with ICIs did not improve efficacy, these findings provide a platform for studying spatial dose distribution and support future development of tumor-targeted alpha therapies to potentiate immunotherapy in mCRPC.
Preclinical • Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
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MYC (V-myc avian myelocytomatosis viral oncogene homolog) • CD4 (CD4 Molecule)
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Xofigo (radium Ra-223 dichloride)
1m
PSMA-617-100: Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer (clinicaltrials.gov)
P1, N=101, Active, not recruiting, Endocyte | Recruiting --> Active, not recruiting
Enrollment closed
|
FOLH1 positive
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abiraterone acetate • Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • 225Ac-vipivotide tetraxetan (AAA817)