UPDATE: Phase 3 Pivotal Trial for 177Lu-NYM032

A PSMA-targeted radioligand built on a compound called NYM032 is heading into the pivotal phase 3 trial that will decide whether its early data hold up. The molecule can be labeled with gallium-68 for PET imaging or lutetium-177 for therapy, giving a matched diagnose-and-treat pair.

In mouse tumor models, escalating the dose from 18.5 to 74 megabecquerels shrank tumors dramatically: at the highest dose, tumor volume after three weeks was about 107 mm³ versus roughly 1,352 mm³ in untreated controls, a more than twelvefold difference. In first-in-human PET imaging of 10 patients, the gallium-68 tracer showed high, PSMA-specific tumor uptake with no adverse events, benchmarked against an existing PSMA imaging agent.

The therapeutic version then moved into a Phase 1/2 dose-escalation trial in heavily pretreated metastatic castration-resistant prostate cancer (we talked about it here), completing enrollment in early 2025. Data presented at ASCO 2025 showed a manageable safety profile and encouraging antitumor activity at doses of just 15–30 millicuries, notably lower than typical doses of the currently approved standard, lutetium-177-PSMA-617 (Pluvicto), which is usually given around 7.4 GBq (roughly 200 millicuries) per cycle.

That standard, lutetium-177-PSMA-617, is the benchmark this candidate will ultimately be measured against. In the pivotal VISION trial, it extended median overall survival to 15.3 months versus 11.3 months with standard care alone, a 4-month benefit and 38% reduction in risk of death. Real-world data have since confirmed that same 15.3-month median, while other cohorts report medians ranging from about 13 to 16 months depending on prior treatment burden.

The new Phase 3 trial for NYM032’s lutetium-177 version follows the VISION blueprint closely: 600 patients randomized 2:1 to the radioligand plus best supportive care versus best supportive care alone, with overall survival as the primary endpoint, continuing until 384 deaths occur, and primary completion projected for November 2028. If the drug can match or beat the roughly 4-month survival edge and 38% mortality risk reduction that defined the approved comparator, while using markedly lower administered activity, it would represent a meaningful improvement in the therapeutic index for this drug class, rather than just another entrant.

Clinical trial.