Theranostic Newsletter | 10.2025 Edition

Here’s your latest dose of Theranostic Insights—a curated snapshot of what’s new and next in the world of theranostics powered by TheranosticTrials.org. From clinical breakthroughs to tech trends, we’ve got the highlights you need to stay ahead.

Latest Theranostic News 📰

Clarity signs copper-67 Supply Agreement with Nusano

Clarity Pharmaceuticals signed a copper-67 supply agreement with Nusano to support its copper-based theranostic programs. Nusano’s 190,000-square-foot Utah facility is expected to open in late 2025, with Cu-67 deliveries targeted for mid-2026 under an initial three-year term, strengthening domestic isotope access for clinical trials and future commercial use. The deal bolsters Clarity’s Targeted Copper Theranostics platform and underscores growing momentum for theranostics in oncology. Continue reading here.

Radiopharm Theranostics Provides Positive Clinical Updates Across Four Programs

Radiopharm Theranostics reported encouraging early data across four programs aligned to its theranostic strategy. RAD101 imaging showed selective uptake in brain metastases in Phase 2b; RAD202 HER2 therapy demonstrated strong tumor uptake and is escalating to a higher dose; RAD204 PD-L1 therapy showed uptake with stable disease for about 5.5 months in two of three last-line NSCLC patients; and RAD301 pancreatic imaging supported a move to Phase 2. These signals suggest growing clinical traction for theranostics, with additional readouts planned by late 2025 and in the first half of 2026. Continue reading here.

Curium, PeptiDream, and PDRadiopharma Enroll First Patient in Registrational Trial of 64Cu-PSMA-I&T for Prostate Cancer in Japan

Curium Group, in partnership with PeptiDream and PDRadiopharma, announced the enrollment of the first patient in a registrational Phase 2 trial of ⁶⁴Cu-PSMA-I&T in Japan. The study will evaluate this Copper-64 PET diagnostic for detecting PSMA-expressing prostate cancer in approximately 70 men scheduled for prostatectomy. The program pairs ⁶⁴Cu-PSMA-I&T with its therapeutic counterpart, ¹⁷⁷Lu-PSMA-I&T, reflecting a fully integrated theranostic approach to prostate cancer care. The trial builds on global data showing strong sensitivity and specificity, advancing access to next-generation radiopharmaceuticals across Asia. Continue reading here.


Perspective Therapeutics Presents Updated Interim Data for [212Pb]VMT-α-NET at ESMO 2025

Perspective Therapeutics reported updated interim results for its alpha-emitting theranostic [212Pb]VMT-α-NET in patients with SSTR2-positive neuroendocrine tumors at ESMO 2025. In 55 treated patients, the therapy was well tolerated, with no dose-limiting toxicities, no grade 4 or 5 adverse events, and no serious renal complications. Among 25 patients with at least 9 months of follow-up, 80% were progression-free. In Cohort 2, patients with SSTR2 in all tumors had a confirmed response rate of 44%, with 14 of 16 patients still on study at a median of 41 weeks. Initial efficacy data for 23 additional Cohort 2 patients and 8 in Cohort 3 are expected in 2026, pointing to continued clinical progress for theranostics. Continue reading here.

Co-PSMA Trial Achieves Primary Endpoint

Clarity Pharmaceuticals announced that the Co-PSMA Phase II trial successfully met its primary endpoint, showing that ⁶⁴Cu-SAR-bisPSMA PET/CT detected significantly more PSMA-positive prostate cancer lesions than the standard ⁶⁸Ga-PSMA-11 PET/CT in patients with low PSA levels. Conducted at St Vincent’s Hospital, Sydney, the study demonstrated improved sensitivity for identifying early recurrence in patients eligible for curative salvage therapy. These findings, supported by previous COBRA and PROPELLER trials, further validate ⁶⁴Cu-SAR-bisPSMA as a best-in-class diagnostic that enhances early detection and precision in theranostic management of prostate cancer. Continue reading here.

Perspective Therapeutics Announces First Patient Dosed with PSV359 in the Second Cohort of a Phase 1/2a Study in Patients with FAP-α Positive Solid Tumors

Perspective Therapeutics treated the first patient in the second cohort of its Phase 1/2a study of [212Pb]PSV359 for FAP-α-positive solid tumors, escalating to 5.0 mCi with up to 4 doses every 8 weeks. Dose escalation was supported by the Safety Monitoring Committee after reviewing two patients at 2.5 mCi, and patients are selected by a theranostic approach using SPECT imaging with [203Pb]PSV359 to confirm FAP-α expression. The trial aims to establish a recommended Phase 2 dose and to assess preliminary anti-tumor activity across multiple FAP-α-expressing cancers, underscoring how theranostics can target the tumor microenvironment.
Continue reading here.

AdvanCell’s 212Pb-ADVC001 Demonstrates Encouraging Safety and Compelling Anti-Tumor Activity in Phase 1b in Prostate Cancer

AdvanCell reported promising results from its TheraPb Phase 1b trial of ²¹²Pb-ADVC001, the first Lead-212–based PSMA-targeted alpha therapy for metastatic castration-resistant prostate cancer. Across seven cohorts, no dose-limiting toxicities or serious treatment-related events were observed, and xerostomia was mostly mild and reversible. At doses of 160 MBq or higher, 80% of patients achieved a PSA50 response, and all patients with measurable disease responded, including 2 complete responses. These results highlight the strong therapeutic index and clinical potential of ²¹²Pb-ADVC001, with Phase 2 expansion now planned to refine dosing and extend theranostic applications in prostate cancer. Continue reading here.

High-Speed Whole-Body SPECT Tracks Tumor Evolution to Optimize Prostate Cancer Treatment

A new study in The Journal of Nuclear Medicine demonstrates that high-sensitivity whole-body CZT SPECT can rapidly and effectively monitor tumor response during ¹⁷⁷Lu-PSMA therapy for metastatic castration-resistant prostate cancer (mCRPC). By completing total-body scans in under 20 minutes, clinicians can track tumor evolution after each treatment cycle without additional tracer injections. The research found that two SPECT-derived metrics—new bone lesion appearance and total lesion activity—were strong predictors of survival, enabling earlier and more personalized adjustments to theranostic treatment plans. This approach could improve outcomes and streamline patient management in theranostics-based prostate cancer care. Continue reading here.

ESMO 2025: Phase III Trial of [177Lu]Lu-PSMA-617 Combined with ADT + ARPI in PSMA-Positive Metastatic Hormone-Sensitive Prostate Cancer (PSMAddition)

The PSMAddition Phase III trial demonstrated that adding ¹⁷⁷Lu-PSMA-617 to standard androgen deprivation therapy (ADT) plus an androgen receptor pathway inhibitor (ARPI) significantly improved radiographic progression-free survival in men with PSMA-positive metastatic hormone-sensitive prostate cancer. Median rPFS was not yet reached, with a hazard ratio of 0.72 favoring the combination arm. Key secondary endpoints—including PSA response, progression-free survival, and time to castration resistance—also improved, with safety consistent with known profiles of ¹⁷⁷Lu-PSMA-617 and ARPIs. These findings support the integration of radioligand therapy earlier in the prostate cancer treatment paradigm, reinforcing theranostic strategies for PSMA-targeted care.
Continue reading here.

NUCLIDIUM Presents Positive Phase I/II Results for First Copper-based PET Diagnostic in Neuroendocrine Tumors at EANM Congress 2025

NUCLIDIUM AG announced promising first-in-human results from its Phase I/II trial of ⁶¹Cu-TraceNET™, a copper-based PET tracer for imaging SSTR2-positive neuroendocrine tumors. The agent demonstrated excellent safety, rapid clearance, and improved tumor visualization compared with standard ⁶⁸Ga-DOTATOC, detecting additional metastases in the liver and lungs. Thanks to its 5.6-hour half-life, ⁶¹Cu-TraceNET™ enables broader clinical distribution and flexible imaging time points. These findings validate NUCLIDIUM’s copper theranostic platform and support advancing both the diagnostic and its paired therapeutic, ⁶⁷Cu-TraceNET™, into trials for SSTR2-positive cancers, including metastatic breast cancer. Continue reading here.

ESMO: AlphaMedix™ Phase 2 Data Support First-in-Class Potential of New Targeted Alpha Therapy in Gastroenteropancreatic Neuroendocrine Tumors

New data from the ALPHAMEDIX-02 Phase 2 study presented at ESMO 2025 show that AlphaMedix™ (²¹²Pb-DOTAMTATE) achieved its primary efficacy endpoints, demonstrating strong and sustained responses in both radioligand therapy (RLT)-naïve and RLT-exposed patients with advanced GEP-NETs. The study reported consistent safety and high treatment completion rates, with manageable toxicity profiles across cohorts. As the first Phase 2 trial of a Lead-212–based targeted alpha therapy, these findings highlight AlphaMedix’s potential to redefine theranostic treatment for rare, difficult-to-treat neuroendocrine cancers. A global Phase 3 study is now in planning. Continue reading here.