A phase I study of ROSE12 alone and in combination with other anti-tumor agents in patients with solid tumors

JRCT ID: jRCT2031230072

Registered date:15/05/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: solid tumor
• Date of first enrollment: 24/05/2023
• Target sample size: 219
• Countries of recruitment: US,Japan
• Study type: Interventional

Intervention(s)

ROSE12:intravenous administration(IV), Prescribed dose
Atezolizumab:intravenous administration(IV), 1200mg, Q3W

Outcome(s)

Primary Outcome

safety, efficacy, phamacokinetics
To evaluate the safety and tolerability based on NCI CTCAE
To evaluate the anti-tumor activity based on RECIST
To evaluate the PK profile of ROSE12

Secondary Outcome

efficacy, phamacokinetics
To evaluate the anti-tumor activity based on RECIST
To evaluate the PK profile of atezolizumab

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 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)

Exclude criteria

- 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

Related Information

• Primary Sponsor: Ajari Ifode
• Secondary ID(s): NCT05907980