AdAPT-001 is an oncolytic adenovirus (OAV) with a transforming growth factor beta (TGF-ß) trap, which neutralizes the immunosuppressive and profibrotic cytokine, TGF-ß. The aim or purpose of this phase 1 study was to assess the safety and tolerability and, secondarily, the efficacy of AdAPT-001 after single intratumoral injection (IT) (Part 1) and multidose IT injection (Part 2) in patients with superficially accessible, advanced refractory solid tumors. Part 1 enrolled 9 patients with a 3 + 3 single dose-escalation safety run-in involving 2.5 × 10¹¹, 5.0 × 10¹¹, 1.0 × 10¹² viral particles (vps). No dose-limiting toxicities or treatment-related serious adverse events (SAEs) were seen. In Part 2, a dose-expansion phase, 19 patients received AdAPT-001 at 1.0 × 10¹² vps until disease progression according to Response Evaluation Criteria in Solid Tumors or RECIST 1.1. The overall responses to treatment included confirmed partial responses (3), durable stable disease ≥ 6 months (5), and progressive disease (13). AdAPT-001 is well tolerated. Evidence of an anti-tumor effect was seen in both injected and uninjected lesions. The recommended Phase 2 dose was 1.0 × 10¹² vp administered by intratumoral injection once every 2 weeks. Combination of AdAPT-001 with a checkpoint inhibition is enrolling.

AdAPT-001 是一种溶瘤腺病毒 (OAV)，具有转化生长因子 β (TGF-ß) 陷阱，可中和免疫抑制和促纤维化细胞因子 TGF-ß。这项 1 期研究的目的或目的是评估 AdAPT-001 在单次肿瘤内注射 (IT)（第 1 部分）和多剂量 IT 注射（第 2 部分）后对浅表可及性患者的安全性和耐受性，以及疗效、晚期难治性实体瘤。第 1 部分招募了 9 名患者，进行了 3 + 3 单次剂量递增安全磨合，涉及 2.5 × 10 ¹¹、5.0 × 10 ¹¹、1.0 × 10 ¹²病毒颗粒 (vps)。未发现剂量限制性毒性或治疗相关的严重不良事件 (SAE)。在第 2 部分（剂量扩展阶段），19 名患者接受 1.0 × 10 ¹²  vps 的 AdAPT-001，直至根据实体瘤疗效评估标准或 RECIST 1.1 出现疾病进展。对治疗的总体反应包括确认的部分反应 (3)、疾病持久稳定≥ 6 个月 (5) 和疾病进展 (13)。AdAPT-001 具有良好的耐受性。在注射和未注射的病变中都观察到了抗肿瘤作用的证据。推荐的 2 期剂量为 1.0 × 10 ¹²  vp，每 2 周瘤内注射一次。AdAPT-001 与检查点抑制的组合正在招募中。