[Translation] FONTANA: A Phase I/IIa, open-label, trial evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of dose-escalating AZD5335 monotherapy and in combination with anticancer agents in subjects with solid tumors. Multi-center modular research
1. 评估AZD5335单药治疗和与抗癌药物联合治疗在晚期实体瘤受试者中的安全性和耐受性。
2. 确定AZD5335单药治疗和与抗癌药物联合治疗进入II期研究的有效剂量(RP2D)。
3. 评估AZD5335单药治疗和联合抗癌药物治疗的初步抗肿瘤活性。
4. 表征AZD5335单药治疗和联合抗癌药物治疗时的PK。
5. 测定AZD5335的免疫原性。
[Translation] 1. To evaluate the safety and tolerability of AZD5335 as monotherapy and in combination with anticancer drugs in subjects with advanced solid tumors.
2. Determine the effective dose of AZD5335 monotherapy and combination therapy with anti-cancer drugs to enter Phase II studies (RP2D).
3. Evaluate the preliminary anti-tumor activity of AZD5335 as a monotherapy and in combination with anti-cancer drugs.
4. Characterize the PK of AZD5335 as a monotherapy and in combination with anticancer drugs.
5. Determine the immunogenicity of AZD5335.