GenSci143 / GeneScience - LARVOL DELTA

GenSci143 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=180 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

First-in-human • New P1 trial • Oncology • Solid Tumor

Changchun GeneScience Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted clinical‑trial approval for its flagship bispecific antibody‑drug conjugate, GenSci143 (flcube.com) - "The drug is designed for advanced solid tumors that express the tumor‑associated antigens B7‑H3 and prostate‑specific membrane antigen (PSMA)....Phase I/II (dose‑escalation & pharmacodynamics) slated to begin Q1 2026 in the U.S. Phase IIb (tumor‑type stratified) planned for Q2 2027 upon favorable safety data."

IND • New P1/2 trial • Prostate Cancer • Solid Tumor

GenSci143, a Novel B7-H3 × PSMA Bispecific Antibody-Drug Conjugate (BsADC), Demonstrates Broad-Spectrum Preclinical Antitumor Efficacy with a Favorable Safety Profile (AACR-NCI-EORTC 2025) - "Clinical limitations of single-target agents include restricted efficacy in mCRPC monotherapy (e.g., DS-7300a [anti-B7-H3 ADC] and ARX517 [anti-PSMA ADC]), often attributed to tumor heterogeneity and variable target expression...Combination potential with enzalutamide (endocrine therapy) was evaluated in a PCa PDX model...The association with the SLFN11 biomarker may further optimize patient stratification. These results position GenSci143 as a promising therapeutic modality with enhanced efficacy and expanded patient coverage potential for mCRPC and beyond."

Preclinical • Castration-Resistant Prostate Cancer • Gastric Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • CD276 • FOLH1 • SLFN11 • TOP1

GenSci143, a novel B7-H3×PSMA bispecific and potential best-in-class ADC, for the treatment of metastatic castration-resistant prostate cancer (AACR 2025) - "In vivo anti-tumor activity of GenSci143 was assessed in CDX models of PCa and compared to that of the DS-7300 and ARX517 analogs. B7-H3 and PSMA were highly co-expressed in PCa tissues (N=102), lending strong support to our dual-targeting therapeutic approach for mCRPC. These results suggest that GenSci143 has the potential to become an effective therapeutic option for mCRPC patients and support its further evaluation in IND-enabling studies."

Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276