Theranostics Newsletter | 05.2025 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’s AMPLIFY Trial Hits First-Patient Imaging Milestone

Clinical-stage theranostics developer Clarity Pharmaceuticals has imaged the first participant in its Phase III AMPLIFY study, evaluating 64Cu-SAR-bisPSMA PET/CT for detecting biochemical recurrence of prostate cancer. The single-arm, 220-patient trial spans U.S. and Australian sites, aiming to generate NDA-level evidence that the dual-targeted tracer can reveal tiny (≈approximately 2 mm) lesions up to six months earlier than current PSMA PET agents, while offering flexible same-day and next-day imaging options. Success would position 64Cu-SAR-bisPSMA as a best-in-class diagnostic and showcase copper-based theranostics for more accessible, centralized manufacturing and nationwide distribution. Continue reading here.

Ratio Therapeutics Plans 65,000-sq-ft Radiopharmaceutical Hub in Utah

Boston-based Ratio Therapeutics has partnered with Wasatch Group’s Medical Innovation Technology Management division to build a 65,000-sq-ft radiopharmaceutical research and manufacturing facility in Salt Lake City. Slated to go live in the second half of 2027, the site will give the theranostics developer scalable GMP capacity to support future commercial demand as its pipeline advances through clinical trials. Continue reading here.

Perspective’s 212Pb VMT-α-NET Shows Durable Responses and Low Toxicity in NET Theranostic Trial

Interim Phase 1/2a data presented at ASCO 2025 confirm that the targeted alpha theranostic [212Pb]VMT-α-NET remains well-tolerated—no dose-limiting toxicities or grade 4/5 events—across 42 neuroendocrine-tumor patients. In Cohort 2 (5 mCi), 4 of 7 participants achieved RECIST responses (three confirmed), while 7 of 9 patients in the first two cohorts stayed progression-free for more than a year, highlighting the agent’s early efficacy signal. Dose escalation will proceed following FDA consultation, positioning this next-gen radiopharmaceutical to meet unmet NET needs. Continue reading here.

Rhenium Obisbemeda Shows 17-Month Survival in Recurrent Glioblastoma

In the phase 1/2 ReSPECT-GBM study, the liposomal theranostic radiotherapeutic rhenium obisbemeda delivered tumor-focused doses of up to 450 Gy, with only mild adverse effects, driving the median overall survival to 17 months—double the 8.5-month benchmark for recurrent glioblastoma. Outcomes improved markedly when absorbed dose exceeded 100 Gy, underscoring a dose-response link and highlighting the potential of theranostics to reshape neuro-oncology care. Continue reading here.

PSMA-11 PET/CT Outshines Fluorocholine in Recurrent Prostate Cancer

In a 46-patient prospective crossover study, [68Ga]Ga-PSMA-11 PET/CT detected 96 % of malignant lesions versus 48 % with [18F]fluorocholine, tripling lesion pick-up at PSA ≤ 1 ng/mL. The theranostic scan enabled more accurate staging and prompted major treatment changes in nearly 9 % of cases, while choline imaging proved useful only for select high-risk patients with negative PSMA results on androgen-deprivation therapy. These findings position PSMA-targeted theranostics as the preferred diagnostic backbone for guiding management of recurrent prostate cancer. Continue reading here.

PARP-Boosted 177Lu-DOTATATE Shows Promise in NET Theranostics

Pairing the theranostic radiopharmaceutical 177Lu-DOTATATE with the PARP inhibitor olaparib proved safe and feasible in an 18-patient phase I study, with mostly mild marrow suppression and nausea. Thrombocytopenia limited dosing only at the highest olaparib level, while early results showed a 69 % disease-control rate at six months—suggesting the DNA-repair blocker may prolong tumor response to peptide receptor radionuclide therapy. These findings support smarter combination theranostics to extend durable control for neuroendocrine tumor patients. Continue reading here.

ITM to Supply n.c.a. Lutetium-177 for Radiopharm’s Theranostic Pipeline

ITM Isotope Technologies Munich SE will supply its FDA-registered, EU-approved non-carrier-added Lutetium-177 to Radiopharm Theranostics under a new agreement, securing isotope access for RAD 204, RAD 202 and RV01 candidates targeting a range of solid tumors. The deal pairs ITM’s high-purity beta-emitter with Radiopharm’s nanobody and antibody platforms, enabling highly precise theranostic treatment that delivers radiation directly to cancer cells while sparing healthy tissue. By locking in a reliable isotope source, Radiopharm reduces supply-chain risk and accelerates the clinical and future commercial rollout of its growing theranostics pipeline. Continue reading here.

DSMC Green-Lights Faster Dose Escalation for 177Lu-RAD204 Theranostics Trial

After confirming strong safety and tumor targeting in the first cohort, an independent DSMC has approved Radiopharm Theranostics’ Phase 1 trial to jump directly to a 60 mCi dose of 177Lu-RAD204 in PD-L1–positive solid tumors. The decision accelerates recruitment across six cancer types and positions the theranostics program for preliminary efficacy data later this year, with full cohort enrollment anticipated by mid-2025. Continue reading here