Henlius (02696) has announced that the first patient has been dosed in a Phase 1 clinical study evaluating its self-developed HLX3902 injection, a STEAP1xCD3xCD28 trispecific antibody, for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and other advanced solid tumors. This milestone was achieved in China (excluding Hong Kong, Macau, and Taiwan), with plans to expand the trial to Australia when conditions permit.
The study is an open-label, first-in-human Phase 1a clinical trial designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of HLX3902 in patients with mCRPC and other advanced solid tumors. It includes eight dose levels ranging from 0.005 mg to 1.5 mg, with a four-week treatment cycle. The 0.005 mg dose group uses an accelerated titration design, while the remaining seven dose groups follow a "3+3" dose escalation design. The primary objectives are to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD). Key endpoints include the incidence of dose-limiting toxicity (DLT) events and the MTD of HLX3902.
HLX3902 is a trispecific antibody T-cell engager developed by Henlius that simultaneously targets STEAP1, CD3, and CD28. By activating both CD3 and CD28, it enhances T-cell killing of STEAP1-expressing tumor cells. Optimizing the first signal (CD3) and second signal (CD28) of T-cell activation boosts T-cell activation, proliferation, and survival, aiming to treat mCRPC and other advanced solid tumors. Preclinical studies indicate favorable antitumor efficacy and safety, suggesting potential clinical benefits. The Phase 1 trial for mCRPC and other advanced solid tumors received clearance in Australia in May 2026 and in China in June 2026.
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