Convergent Therapeutics to Present Phase 2 Data for CONV01-α in Lu-PSMA Pretreated Metastatic Prostate Cancer at ASCO 2026
核心洞察
Convergent Therapeutics (搜索) will present Phase 2 CONVERGE-01 trial data for CONV01-α at the 2026 ASCO Annual Meeting, focusing on patients with metastatic castration-resistant prostate cancer (搜索) previously treated with Lu-177 PSMA radioligand therapy (搜索).
CONV01-α is a PSMA (搜索)-targeted actinium-225 (搜索) radioantibody that delivers high-energy alpha particle radiation directly to tumor cells while limiting exposure to surrounding tissues.
Initial studies in more than 120 patients have established clinical proof-of-concept for CONV01-α, demonstrating consistent antitumor activity and a differentiated safety profile.
Convergent Therapeutics (搜索) Inc., a clinical-stage biotechnology company developing next-generation alpha-emitting radioantibodies for advanced prostate cancer (搜索) treatment, announced that results from its ongoing Phase 2 CONVERGE-01 trial of CONV01-α will be presented at the 2026 ASCO Annual Meeting. The oral presentation, scheduled for June 1 in Chicago, will highlight data from patients with metastatic castration-resistant prostate cancer (搜索) (mCRPC (搜索)) previously treated with Lu-177 PSMA radioligand therapy (搜索).
Addressing an Emerging Treatment Challenge
"We appreciate the opportunity to share these data at ASCO and to contribute to the discussion around how prostate cancer (搜索) treatment is evolving," said Philip Kantoff, MD, Chief Executive Officer and Co-Founder of Convergent Therapeutics (搜索). "As targeted radiotherapies become more integrated into care, there is growing focus on how to extend benefit for patients who have already received Lu-177 PSMA radioligand therapy (搜索) and need further options. This is an important emerging challenge in mCRPC (搜索), and one that will help define the next phase of progress in the field."
The presentation will be delivered by Michael J. Morris, MD, Prostate Cancer (搜索) Section Head at Memorial Sloan Kettering Cancer Center, during the Clinical Science Symposium titled "Radiation Re-Imagined: Radioligand Innovation in Prostate Cancer" on June 1 from 3:00 PM-4:30 PM CDT.
CONVERGE-01 Trial Design and Structure
The CONVERGE-01 trial is a Phase II, randomized, open-label, multicenter three-part study designed to assess the safety and efficacy of CONV01-α in patients with mCRPC (搜索). The trial's innovative design addresses different patient populations based on their prior treatment history.
In Part 1, patients received rosopatamab tetraxetan (搜索) to characterize the biodistribution of the radioantibody to target organs and prostate cancer (搜索) lesions. Participants were then enrolled in either Part 2 (dose optimization) or Part 3 (dose escalation) depending on their prior treatment history. Part 2 enrolled Lu-177-PSMA (搜索)-radioligand therapy-naïve participants, while Part 3 enrolled participants who received prior Lu-177-PSMA-radioligand therapy. All patients receive Ac-225 rosopatamab tetraxetan in a single fractionated two-week cycle.
CONV01-α: Precision Alpha Radiation Therapy
CONV01-α is a PSMA (搜索)-targeted Ac-225 radioantibody that pairs antibody precision with the localized potency of alpha radiation. The therapy uses a humanized monoclonal antibody directed at prostate-specific membrane antigen (搜索) (PSMA), a well-established and highly expressed antigen in prostate cancer (搜索).
CONV01-α is differentiated by its ability to precisely deliver actinium-225 (搜索) (Ac-225) through this PSMA (搜索)-targeting antibody, enabling short-range, high-energy alpha particle radiation that creates focused DNA damage within tumor cells while limiting exposure to surrounding tissues. This selectivity, combined with strong tumor retention and minimal salivary and renal uptake, supports the potential of CONV01-α to be a clinically impactful therapy for PSMA-positive cancers.
Clinical Proof-of-Concept Established
Initial studies in more than 120 patients have established clinical proof-of-concept for CONV01-α, showing consistent antitumor activity and a differentiated safety profile. These results demonstrate the therapy's potential to address the growing need for effective treatment options in patients who have progressed after Lu-177 PSMA radioligand therapy (搜索).
The upcoming ASCO presentation will provide detailed safety and efficacy data from the CONVERGE-01 trial's Part 3, specifically focusing on patients with mCRPC (搜索) who had previously received Lu-177 PSMA radioligand therapy (搜索), representing a critical patient population with limited treatment options.