A phase Ia/Ib open-label, dose-escalation study to evaluate the safety and pharmacokinetics of ROSE12 as a single agent and in combination with other anti-tumor agents in patients with locally advanced or metastatic solid tumors

Ajari Ifode0 个研究点目标入组 219 人开始时间: 2023年5月15日最近更新: 2023年10月17日

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•Age >= 18 years at time of signing informed consent form (ICF)
•- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
•- Adequate hematologic and end-organ function
•- Life expectancy >= 12 weeks
•- Patients with histologic documentation of locally advanced, or metastatic solid tumor
•- [Dose-escalation Parts and Biopsy Parts]Refractory or resistant to standard therapies or standard therapies are not available
•- [Dose-escalation Parts and Expansion Part] Patients with confirmed availability of fresh tumor or representative tumor specimens
•- [Biopsy Parts] Patients with accessible lesion(s)

•- Clinically significant cardiovascular or liver disease
•- Treatment with investigational therapy and anti-cancer therapy within 28 days prior to initiation of study drug
•- Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy (other than asymptomatic elevation of serum amylase or lipase).
•- All imAEs from prior cancer immunotherapy (other than endocrinopathy managed with replacement therapy, stable vitiligo or stable alopecia) that have not resolved completely to baseline.
•- Adverse events from prior anti-cancer therapy that have not resolved to Grade <= 1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
•- Primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases
•- Uncontrolled tumor-related pain
•- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
•- Active or history of clinically significant autoimmune disease
•- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
•[Expansion Part]
•- Prior treatment with investigational product which has MoA of Treg depletion
•- Malignancies other than disease under study within 5 years prior to Cycle 1 Day 1

发起方

Ajari Ifode