CAMBRIDGE, Mass. — Convergent Therapeutics Inc., a clinical-stage biotechnology company developing radiopharmaceutical treatments for cancer, announced positive Phase 2 clinical trial results for its investigational prostate cancer therapy, CONV01-α, demonstrating significant anti-tumor activity and a favorable safety profile in patients with advanced disease.
The findings from Part 2 of the Phase 2 CONVERGE-01 study will be presented at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid.
The study evaluated Ac-225 rosopatamab tetraxetan (CONV01-α) in patients with androgen pathway modulator-resistant (APMR) prostate cancer who had not previously received lutetium-based prostate-specific membrane antigen (Lu-PSMA) therapy.
According to the company, the investigational treatment achieved a PSA50 response rate of 84%, indicating that 84% of patients experienced a reduction of at least 50% in prostate-specific antigen (PSA) levels. Additionally, 26% of patients achieved a PSA90 response, representing a reduction of at least 90% in PSA levels.
These responses were observed following a two-dose treatment regimen in patients with rapidly progressing prostate cancer.
Convergent reported that the therapy was generally well tolerated, with manageable blood-related side effects at the target dose. Researchers observed no kidney or liver toxicity or severe cases of dry mouth, a potential complication associated with certain radiopharmaceutical treatments.
The study also demonstrated the feasibility of directly measuring radiation exposure from Actinium-225 in healthy organs. The company said the resulting estimates supported the favorable safety findings reported to date.
“The depth of PSA responses observed with only two doses of Ac-225 rosopatamab tetraxetan, together with its favorable safety profile, offers a particularly compelling option for patients with metastatic castration-resistant prostate cancer (or APMR) who have not yet received Lu-PSMA, a population for whom novel treatment options are needed,” said Praful Ravi, medical director of Genitourinary Theranostics at Dana-Farber Cancer Institute.
“The patient-friendly two-dose regimen also has the potential to substantially reduce treatment burden, allowing patients to resume their usual activities and family lives at home without prolonged radiation-related isolation,” Ravi added.
The latest findings build on previously reported Phase 2 results involving patients who had already undergone Lu-PSMA therapy, suggesting that CONV01-α could have potential applications both before and after existing radiopharmaceutical treatments.
Philip Kantoff, M.D., co-founder and chief executive officer of Convergent Therapeutics, said the results support the company’s broader development strategy for the investigational treatment.
“These results reinforce our conviction that CONV01-α has the potential to become an important treatment option across the prostate cancer therapy continuum,” Kantoff said.
“Demonstrating substantial anti-tumor activity in patients both before and after Lu-PSMA treatment underscores the significant opportunity for targeted alpha therapies in a disease where curative options remain limited. We look forward to continuing CONVERGE-01, further exploring its potential in this earlier treatment setting and advancing our development plans to bring this promising therapy to patients,” he added.
Convergent plans to continue evaluating CONV01-α as a standalone treatment while exploring its potential use in combination with other cancer therapies.
The treatment remains investigational, and additional clinical studies will be needed to establish its long-term safety and effectiveness.
