Adcentrx Therapeutics has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its investigational therapy, ADRX-0706.

Adcentrx Therapeutics 的研究性疗法 ADRX-0706 已获得美国食品药品监督管理局 (FDA) 的快速通道资格。

ADRX-0706 is a proprietary ADC created by Adcentrx using its i-Conjugation® technology platform. It combines a fully human IgG1 antibody that targets Nectin-4 with a tubulin inhibitor payload, AP052. The conjugate uses a cleavable linker and stable binding chemistry to improve delivery of the drug to tumour cells..

ADRX-0706 是 Adcentrx 使用其 i-Conjugation® 技术平台开发的一种专利抗体药物偶联物 (ADC)。它结合了靶向 Nectin-4 的全人源 IgG1 抗体和微管蛋白抑制剂有效载荷 AP052。该偶联物采用可裂解连接子和稳定的结合化学技术，以改善药物向肿瘤细胞的递送。

Advanced cervical cancer refers to cancer that has spread beyond the cervix to nearby tissues or distant organs. It typically includes stages III and IV of the disease. Common symptoms at this stage may include pelvic pain, abnormal bleeding, and fatigue. Treatment options are often limited and may involve chemotherapy, radiotherapy, or targeted therapies.

晚期宫颈癌是指癌症已经扩散到宫颈以外的附近组织或远处器官。它通常包括疾病的第三期和第四期。此阶段的常见症状可能包括盆腔疼痛、异常出血和疲劳。治疗选择通常有限，可能涉及化疗、放疗或靶向治疗。

The condition remains difficult to treat, especially in patients whose cancer returns or progresses after initial therapy. There is a continued need for more effective treatments for this patient population..

这种病症仍然难以治疗，尤其是在癌症患者复发或初步治疗后进展的情况下。这类患者群体仍需要更有效的治疗方法。

The treatment is intended for patients with locally advanced or metastatic squamous cell cervical cancer.

该治疗方案适用于局部晚期或转移性鳞状细胞宫颈癌患者。

ADRX-0706 is a Nectin-4-targeting Antibody-Drug Conjugate (ADC) currently being assessed in a Phase 1b clinical study as part of an ongoing Phase 1a/b trial (NCT06036121).

ADRX-0706 是一种靶向 Nectin-4 的抗体药物偶联物 (ADC)，目前正在进行 1b 期临床研究，作为正在进行的 1a/b 期试验 (NCT06036121) 的一部分。

Initial data suggest the therapy has a favourable safety and pharmacokinetic profile, with fewer side effects such as peripheral neuropathy. Early signs of effectiveness have also been observed in various tumour types. Nectin-4 is highly expressed in cervical cancer cells and is associated with poor outcomes, making it a relevant target for this type of therapy..

初步数据显示，该疗法具有良好的安全性和药代动力学特性，且副作用较少，例如周围神经病变。在多种肿瘤类型中也观察到了早期有效性迹象。Nectin-4在宫颈癌细胞中高表达，并与不良预后相关，因此成为这种疗法的相关靶点。

This trial involves patients with several types of advanced solid tumours, including cervical cancer.

本试验涉及多种晚期实体瘤患者，包括宫颈癌。

Source: prnewswire.com

来源：prnewswire.com