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
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
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.- Initial results expected 4Q 2025
- 初步结果预计在2025年第四季度发布
SAN DIEGO, Jan. 6, 2025 /PRNewswire/ -- Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company advancing innovative protein conjugates for cancer and other life-threatening diseases, today announced the first patient dosed in the Phase 1a/b study of ADRX-0405 for the treatment of advanced solid tumors.
圣地亚哥, 2025年1月6日 /PRNewswire/ -- Adcentrx Therapeutics（"Adcentrx"）是一家临床阶段的生物技术公司，致力于开发创新的蛋白质偶联物用于癌症及其他危及生命的疾病，今天宣布在ADR-0405用于治疗晚期实体瘤的1a/b期研究中首位患者接受了给药。
"Advancing our second program into clinical trials marks an important milestone for Adcentrx and further validates the potential of our ADC technology platform," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "STEAP1 is an attractive ADC target, and we are excited about the first-in-class potential for ADRX-0405. We believe this novel ADC offers a unique approach to treating patients with STEAP1-expressing cancers, such as metastatic castration-resistant prostate cancer, where a significant unmet need remains for new targeted therapies."
“将我们的第二个项目推进到临床试验是Adcentrx的重要里程碑，进一步验证了我们ADC科技平台的潜力，”Adcentrx的创始人兼首席执行官Hui Li博士说。“STEAP1是一个具有吸引力的ADC靶点，我们对ADR-0405的首创潜力感到激动。我们相信这种新型ADC为治疗表达STEAP1的癌症患者提供了一种独特的方法，例如转移性去势抵抗性前列腺癌，这里在新靶向治疗方面仍有显著的未满足需求。”
Adcentrx doses first patient in Phase 1a/b study of ADRX-0405, a potential first-in-class STEAP1-targeting ADC.
Adcentrx在ADR-0405的1a/b期研究中给首位患者给药，该药物是潜在的首创STEAP1靶向ADC。
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.
ADR-0405的首次人体1a/b期临床试验是一项公开标签的剂量递增和剂量扩展研究，正在美国的多个地点进行。该试验正在招募具有选择性晚期实体瘤的患者，主要目标是描述ADR-0405的安全性和耐受性，并确定最佳剂量。公司预计将在2025年第四季度获得初步数据。
About ADRX-0405
关于ADR-0405
ADRX-0405 is a next-generation antibody-drug conjugate (ADC) composed of a humanized IgG1 antibody targeting six-transmembrane epithelial antigen of the prostate 1 (STEAP1), a cell surface protein that is upregulated in prostate cancer and certain other cancers, yet has limited expression in normal healthy tissue.
ADRX-0405是一种新一代抗体药物偶联物（ADC），由一种人源化IgG1抗体组成，靶向前列腺六跨膜上皮抗原1（STEAP1），这是一种在前列腺癌和其他某些癌症中上调的细胞表面蛋白，在正常健康组织中的表达有限。
Adcentrx's proprietary i-Conjugation technology platform is an important component in the design of ADRX-0405. The platform utilizes protease-cleavable linkers and stable conjugation chemistry to enhance payload delivery. This advanced technology ensures a highly stable ADC with a topoisomerase inhibitor payload conjugated at a drug-to-antibody ratio of eight (DAR 8). ADRX-0405 preclinical studies have demonstrated its favorable pharmacokinetics, safety profile, and significant efficacy across multiple tumor models.
Adcentrx的专有i-Conjugation科技平台是ADRX-0405设计中一个重要的元件。该平台利用可被蛋白酶切割的连接器和稳定的结合化学，以增强药物载荷的传递。这项爱文思控股科技确保了一个高度稳定的ADC，其拓扑异构酶抑制剂药物载荷与抗体的比率为八（DAR 8）。ADRX-0405的临床前研究展示了其良好的药代动力学、安全性和在多个肿瘤模型中的显著疗效。
For more information about the ADRX-0405 Phase 1a/b clinical trial, please refer to the Study ID NCT06710379 on ClinicalTrials.gov.
如需有关ADRX-0405 1a/b期临床试验的更多信息，请参考ClinicalTrials.gov上的研究ID NCT06710379。
About Adcentrx Therapeutics
关于Adcentrx Therapeutics
Adcentrx is a biotechnology company focused on accelerating breakthroughs in protein conjugate therapeutic development for cancer and other life-threatening diseases. Adcentrx has pioneered the development of i-Conjugation, an ADC technology platform addressing key components of protein conjugate design to solve challenges typically seen in ADCs. In addition to ADRX-0405, Adcentrx is developing a robust pipeline of ADCs with first-in-class and best-in-class potential, including ADRX-0706, a Nectin-4 targeting ADC currently in a Phase 1a/b clinical trial (Study ID NCT06036121 on ClinicalTrials.gov).
Adcentrx是一家生物技术公司，专注于加速针对癌症和其他危急疾病的蛋白连接治疗开发的突破。Adcentrx在i-Conjugation的开发中处于领先地位，这是一种针对ADC设计关键元件的技术平台，旨在解决通常在ADC中看到的挑战。除了ADRX-0405，Adcentrx还在开发一系列具有首创和最佳潜力的ADC，包括ADRX-0706，这是一种针对Nectin-4的ADC，目前正在进行1a/b期临床试验（ClinicalTrials.gov上的研究ID NCT06036121）。
For more information about Adcentrx and its innovative ADC technologies, please visit .
如需有关Adcentrx及其创新ADC科技的更多信息，请访问。
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SOURCE Adcentrx Therapeutics
来源 Adcentrx Therapeutics
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