P1/2, N=46, Terminated, Servier Bio-Innovation LLC | Completed --> Terminated; Sponsor decision to terminate during Phase 1

P2, N=1, Terminated, Genmab | Trial completion date: Jul 2029 --> May 2026 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2027 --> May 2026; Genmab has decided to discontinue further clinical development of acasunlimab following strategic portfolio prioritization. The decision was not related to safety concerns.

Importantly, this 5T4-restricted activation mechanism confines immune stimulation to the tumor microenvironment, thereby circumventing the systemic toxicity associated with conventional 4-1BB agonists. Collectively, these findings establish FTL008.16 as a conditionally active immunotherapeutic agent that successfully achieves both robust antitumor efficacy and a favorable safety profile.

P1/2, N=39, Completed, Lyvgen Biopharma Holdings Limited | Recruiting --> Completed | N=65 --> 39 | Trial primary completion date: Mar 2025 --> Dec 2025

P1, N=66, Completed, Lyvgen Biopharma Holdings Limited | Active, not recruiting --> Completed | N=126 --> 66

P2, N=64, Active, not recruiting, Lyvgen Biopharma Holdings Limited | Recruiting --> Active, not recruiting

P1, N=105, Completed, Lyvgen Biopharma Holdings Limited | Active, not recruiting --> Completed | N=276 --> 105

P1/2, N=265, Not yet recruiting, Regeneron Pharmaceuticals

IBD0333 is a tumor-conditionally activated anti-CD24×4-1BB bsAb that demonstrates potent antitumor efficacy along with a favorable safety and pharmacokinetic profile. These findings support its further clinical development.

P1, N=392, Recruiting, BeOne Medicines | N=140 --> 392 | Trial completion date: Dec 2026 --> May 2028 | Trial primary completion date: Oct 2026 --> May 2028

Tumor biopsies confirmed radioactivity. 89Zr-CB307 selectively accumulated in PSMA-positive tumor lesions without specific uptake in PSMA-positive-normal or lymphoid tissues in patients with mCRPC.

These findings establish the isotype-specific efficacy of 4-1BB agonists and support 4-1BB stimulation combined with TQ as a promising strategy to enhance durable immunotherapeutic responses in MM.