A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects with Select Advanced Solid Tumors

MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC0 个研究点目标入组 746 人开始时间: 2016年11月24日最近更新: 2022年2月1日

适应症

试验速览

暂无简介。

•1. Subjects must have histologic documentation of advanced recurrent or metastatic cancer.
•2. Subjects must be at the recurrent/metastatic setting, with selected advanced solid tumors.
•3. Subjects must have at least one lesion that is measurable by RECIST v1.1
•4. Part 3, Dose exploration, CRC subjects can be treatment naïve but should not have received more than two lines of systemic therapy in the recurrent/metastatic setting.
•Please refer to the protocol for a full list of the inclusion criteria.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 596
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 150

•1. Prior treatment with immunotherapy agents. Prior treatment with antitumor vaccines may be permitted upon discussion with the medical monitor.
•2. Prior participation in clinical studies that include durvalumab alone or in combination, where the study has registrational intent and the analyses for the primary endpoint have not yet been completed
•3. Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of study treatment
•4. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable
•Please refer to the protocol for a full list of the exclusion criteria.

发起方

MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC