ADRX-0405 / Adcentrx Therap - LARVOL DELTA

Preclinical characterization of a novel STEAP1 antibody-drug conjugate ADRX-0405 for the treatment of mCRPC (AACR 2025) - "In summary, the preclinical efficacy and safety profile of ADRX-0405 strongly supports its clinical evaluation in mCRPC. A phase 1a/b study with ADRX-0405 is initiated."

IO biomarker • Preclinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CASP3 • PD-L1 • STEAP1

Adcentrx Therapeutics to Showcase Novel STEAP1 and NaPi2b ADCs with Oral and Poster Presentations at AACR 2025 (PRNewswire) - "Adcentrx Therapeutics...will present new data at the American Association for Cancer Research (AACR) Annual Meeting 2025....The company will deliver an oral presentation on ADRX-0405, its clinical-stage STEAP1 ADC, and a poster presentation on ADRX-0134, its preclinical NaPi2b ADC. The presentations will underscore the versatility of Adcentrx's ADC platform, showing advancements in therapeutic window expansion, bystander effect optimization, and payload delivery improvements for targeted cancer therapy."

Preclinical • Castration-Resistant Prostate Cancer

Adcentrx Therapeutics Announces First Patient Dosed in the Phase 1a/b Study of ADRX-0405, a Potential First-in-Class ADC Targeting STEAP1 for the Treatment of Advanced Solid Tumors (PRNewswire) - "The first-in-human Phase 1a/b clinical trial of ADRX-0405 is an open-label dose escalation and dose expansion study being conducted across sites in the U.S. The trial is enrolling patients with select advanced solid tumors, with the primary objectives of characterizing the safety and tolerability of ADRX-0405 and determining its optimal dose. The company anticipates an initial data readout in 4Q 2025."

P1 data • Trial status • Solid Tumor

A Study of ADRX-0405 in Subjects with Select Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=68 | Recruiting | Sponsor: Adcentrx Therapeutics

Metastases • New P1 trial • Oncology • Solid Tumor

Adcentrx Therapeutics Announces FDA Clearance of Investigational New Drug Application for ADRX-0405, a Potential First-in-Class ADC Targeting STEAP1 for the Treatment of Advanced Solid Tumors (PRNewswire) - "Adcentrx Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application of ADRX-0405 for the treatment of select advanced solid tumors....The planned first-in-human Phase 1a/b clinical trial of ADRX-0405 is an open-label, multicenter, non-randomized dose escalation and dose expansion study. The study will enroll patients with select advanced solid tumors, including metastatic castration resistant prostate cancer. The primary objectives of the study will be to characterize the safety and tolerability and to determine the optimal dose of ADRX-0405. The company anticipates the first patient to be enrolled in 4Q 2024, with an estimated initial data readout in 4Q 2025."

IND • New P1 trial • Castration-Resistant Prostate Cancer • Solid Tumor