A phase I study of ROSE12 alone and in combination with other anti-tumor agents in patients with solid tumors
- Conditions
- solid tumor
- Registration Number
- JPRN-jRCT2031230072
- Lead Sponsor
- Ajari Ifode
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 219
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety, efficacy, phamacokinetics<br>To evaluate the safety and tolerability based on NCI CTCAE<br>To evaluate the anti-tumor activity based on RECIST<br>To evaluate the PK profile of ROSE12
- Secondary Outcome Measures
Name Time Method efficacy, phamacokinetics<br>To evaluate the anti-tumor activity based on RECIST<br>To evaluate the PK profile of atezolizumab