Clinical Trials Bullish 6 Based on a press release

Phase 1 Trial Launches for Ac-225 PSMA Therapy: 1st Patient Dosed in mCRPC

Blue Earth Therapeutics doses first patient in Phase 1 trial of actinium-225 rhPSMA-10.1 for mCRPC, aiming to assess safety and inform dose selection. The trial leverages PSMA targeting with high-energy alpha particles to kill cancer cells. Results could shape the next wave of radioligand therapies.

· 3 min read · Verified by 2 sources · By Biotech Intelligence Brief Editorial
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Key Takeaways

  • Blue Earth Therapeutics doses first patient in Phase 1 trial of actinium-225 rhPSMA-10.1 for mCRPC, aiming to assess safety and inform dose selection.
  • The trial leverages PSMA targeting with high-energy alpha particles to kill cancer cells.
  • Results could shape the next wave of radioligand therapies.

Mentioned

Blue Earth Therapeutics company University College London (UCL) company Actinium-225 (²²⁵Ac) technology rhPSMA‑10.1 Injection product 177Lu rhPSMA‑10.1 Injection product PSMA company Metastatic castration‑resistant prostate cancer (mCRPC) company

Key Intelligence

Key Facts

  1. 1First patient dosed in Phase 1 trial (NCT07414940) evaluating Actinium (225Ac) rhPSMA‑10.1 Injection in metastatic castration‑resistant prostate cancer.
  2. 2Study sponsored by University College London (UCL), conducted at UCL Hospital, with funding and drug supply from Blue Earth Therapeutics.
  3. 3Trial will assess safety, tolerability, radiation dosimetry, and anti‑tumour activity to inform dose selection for subsequent research.
  4. 4Actinium-225 alpha particles deliver high‑energy, short‑range radiation causing irreparable DNA damage, aiming to limit collateral tissue exposure.
  5. 5This is Blue Earth’s second clinical radioligand candidate; its Lutetium (177Lu) rhPSMA‑10.1 program is already in Phase 2.
  6. 6mCRPC remains an area of high unmet need with median survival of approximately 1–2 years after progression on standard therapies.
Alpha RLT Market Sentiment

Analysis

For biotech investors and developers, Blue Earth Therapeutics' initiation of a Phase 1 trial for its alpha‑emitting PSMA‑targeted therapy marks a strategic expansion beyond its ongoing lutetium‑177 program. This trial will generate critical dosimetry and safety data that could differentiate rhPSMA‑10.1 in a competitive radiopharmaceutical landscape where next‑generation alpha approaches aim to overcome resistance to beta emitters like Pluvicto.

Blue Earth Therapeutics has dosed the first participant in a Phase 1 clinical trial (NCT07414940) investigating Actinium (225Ac) rhPSMA-10.1 Injection, an alpha-emitting radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) for metastatic castration-resistant prostate cancer (mCRPC). The study, sponsored by University College London and conducted at UCL Hospital, marks the company’s second clinical candidate, building on its ongoing Phase 2 program with Lutetium (177Lu) rhPSMA‑10.1. This move into alpha therapy underscores a broader industry shift toward more potent radionuclides to overcome resistance to beta-emitting agents like Novartis’s Pluvicto (177Lu-PSMA-617). The trial will evaluate safety, tolerability, radiation dosimetry, and preliminary anti-tumour activity—data that are essential for dose selection in later-phase studies.

The commercial success of Pluvicto, which generated $2.7 billion in 2025 sales, has fueled investment in next-generation PSMA agents.

Actinium-225, an alpha emitter with a half-life of 10 days, produces high linear energy transfer particles that travel only 50–80 μm in tissue, causing irreparable DNA double-strand breaks while theoretically sparing surrounding healthy tissue. This property makes it particularly attractive for micro-metastatic disease, where short-range damage may reduce off-target toxicities such as salivary gland and renal injury seen with beta therapies. Blue Earth’s radiohybrid (rh) platform enables both imaging and therapy using the same targeting moiety, facilitating theranostic matching—a critical advantage in personalized oncology. The Phase 1 trial is designed to characterize dosimetry, which will clarify tumor uptake and critical organ exposure, informing a therapeutic window.

What to Watch

The initiation comes at a pivotal moment for targeted radiopharmaceuticals. The commercial success of Pluvicto, which generated $2.7 billion in 2025 sales, has fueled investment in next-generation PSMA agents. Several competitors are advancing actinium-225 programs, including Novartis’s own [¹⁷⁷L]Lu-PSMA-617 and pre-targeted approaches, point biopharma, and Actinium Pharmaceuticals. Supply constraints for actinium-225—currently sourced from limited cyclotron production and legacy nuclear material—remain a significant bottleneck, potentially impacting trial timelines and commercialization. Blue Earth’s partnership with UCL provides academic credibility and access to clinical infrastructure, but the company will need to demonstrate robust safety and efficacy signals to attract partnership or funding for registrational trials.

For the biotech and pharma sector, this trial represents a high-risk, high-reward proposition. Positive safety and dosimetry results could validate the rhPSMA-10.1 backbone for alpha therapy and lead to accelerated expansion into earlier lines of therapy. Conversely, poor tolerability due to salivary gland or marrow uptake could stall development. The trial’s design includes patients who have progressed on prior therapies, including likely beta-radioligand therapy, offering a realistic assessment of cross-resistance. Expected data readouts, likely by mid-2027, will be closely watched by investors and pharma partners as a bellwether for the alpha-radioligand space. Forward-looking, Blue Earth may leverage the same targeting vector to explore other alpha-emitters like astatine-211 or thorium-227, further expanding its pipeline.

Timeline

Timeline

  1. First Participant Dosed

Sources

Sources

Based on 2 source articles

Cite This Page

"Phase 1 Trial Launches for Ac-225 PSMA Therapy: 1st Patient Dosed in mCRPC." Biotech Intelligence Brief, July 27, 2026. https://getbiobrief.com/story/blue-earth-phase1-ac225-psma-trial-first-patient

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Signal on this pageWhat it tells you
Verified by N sourcesIndependent corroboration count. N≥2 is our confidence floor; N=1 is marked explicitly.
Impact score (1-10)Regulatory + financial + operational weight. 8+ signals an experienced-operator action item.
SentimentFive-tier classification trained on labeled biotech-specific corpora.
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