DXC008 / Hangzhou DAC Biotech - LARVOL DELTA

STEAP1-targeted strategies in advanced prostate cancer: a review on therapeutic and diagnostic implications. (PubMed, Prostate Cancer Prostatic Dis) - "STEAP1 represents a promising diagnostic and therapeutic target in prostate cancer, and its potential role in shaping future management of the disease warrants continued investigation."

Journal • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • STEAP1

STEAP1-targeted strategies in advanced prostate cancer: a review on therapeutic and diagnostic implications (Nature) - "This review discusses STEAP1-based diagnostics, including molecular imaging (89Zr-DFO-MSTP2109A) and liquid biopsy methods, as well as therapeutics, such as STEAP1 antibodies, antibody-drug conjugates (DSPT3086S, ADRX-0405, ABBV-969, and DXC008), chimeric antigen receptor T-cell therapy (STEAP1 CAR-T), bispecific T-cell engagers (Xaluritamig/AMG 509, BC261), and cancer vaccines....STEAP1 represents a promising diagnostic and therapeutic target in prostate cancer, and its potential role in shaping future management of the disease warrants continued investigation."

Review • Prostate Cancer

Recent advances in antibody-drug conjugates for metastatic castration-resistant prostate cancer. (PubMed, Zhejiang Da Xue Xue Bao Yi Xue Ban) - P3 | "Among prostate-specific membrane antigen (PSMA)-targeted ADCs, ARX517 demonstrates superior safety and more significant prostate-specific antigen (PSA) reductions compared to earlier agents such as MLN2704, PSMA-ADC, and MEDI3726. ADCs targeting B7-H3, such as MGC018 and DB-1311, have also shown antitumor activity. ADCs targeting other antigens, including six-transmembrane epithelial antigen of the prostate (STEAP)1 (DSTP3086S), trophoblast cell surface antigen (TROP)2 (sacituzumab govitecan), and solute carrier (SLC) 44A4 (ASG-5ME), have shown preliminary antitumor activity in early trials but face challenges with insufficient efficacy or toxicity. Tisotumab vedotin (targeting tissue factor) has shown no significant therapeutic response in mCRPC. Meanwhile, disitamab vedotin (HER2-targeted), ABBV-969 (dual PSMA/STEAP1-targeted), and DXC008 (dual PSMA/STEAP1-targeted) are currently under evaluation. Notably, the B7-H3-targeted ADC ifinatamab deruxtecan has initiated..."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • HER-2 • SLC44A4 • SLC4A4 • STEAP1

A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Hangzhou DAC Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Ewing Sarcoma • Genito-urinary Cancer • Oncology • Prostate Cancer • Sarcoma • Solid Tumor

A Phase I, Open-Label, Multicenter, First-in-Human, Dose Escalation and Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profiles and Preliminary Efficacy of DXC008 in Patients with Prostate Cancer and Other Solid Tumors (such as Ewing Sarcoma) (ChiCTR) - P2 | N=110 | Not yet recruiting | Sponsor: Peking University First Hospital; Hunan Cancer Hospital; Hangzhou DAC Biotechnology Co.,Ltd.

New P2 trial • Castration-Resistant Prostate Cancer • Ewing Sarcoma • Genito-urinary Cancer • Oncology • Prostate Cancer • Sarcoma • Solid Tumor

The anti-STEAP1/PSMA ADC, DXC008: Assessment of anti-tumor efficacy, pharmacokinetic, and toxicity properties. (ASCO 2025) - "DXC008 exhibits a promising preclinical profile, including potent dual-target antitumor activity, favorable pharmacokinetics, and a well-tolerated safety profile. These findings demonstrate the potential of DXC008 to become a best-in-class (BIC) STEAP1/PSMA-targeting ADC, and to offer a favorable benefit-risk ratio for clinical development."

Clinical • PK/PD data • Ewing Sarcoma • Gastric Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Sarcoma • Solid Tumor • STEAP1

A Study of DXC008 in Patients With Prostate Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=110 | Not yet recruiting | Sponsor: Hangzhou DAC Biotechnology Co., Ltd.

New P1 trial • Ewing Sarcoma • Genito-urinary Cancer • Oncology • Prostate Cancer • Sarcoma • Solid Tumor

DXC008, a novel STEAP1 antibody-tubulysin analog conjugate with a function linker, demonstrates a potential to broaden therapeutic opportunities for prostate tumors (AACR 2024) - "A Steap1 antibody called Vandortuzumab conjugated with MMAE (DSTP3086S) was in the clinical phase I trial for treating STEAP1-expressing metastatic castration-resistant prostate cancer and showed acceptable safety at 2.4 mg/kg once every 3 weeks. Pharmacokinetic profiles of DXC008 were favorable and the safety of Maximal Tolerable Dose (MTD) was over 120 mg/kg in single injection in mice. DXC008 has been forward to NHP toxicity study and it has potential to be a good STEAP1/PSMA-targeting ADC with a wide therapeutic window for prostate cancers."

Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1 • STEAP1