A PHASE I/II STUDY OF ATEZOLIZUMAB 1680 MG EVERY 4 WEEKS IN PATIENTS WITH ADVANCED SOLID TUMOR

JRCT ID: jRCT2031220151

Registered date:21/06/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Advanced Solid Tumors
• Date of first enrollment: 16/09/2022
• Target sample size: 21
• Study type: Interventional
• Intervention(s): Atezolizumab: Atezolizumab(Genetical Recombination) 1680 mg once every 4 weeks by intravenous infusion.

Outcome(s)

Primary Outcome

Safety, Phamacokinetics
- Dose-limiting toxicity (DLT)
- Safety ( incidence of adverse events, severity assessed by NCI CTCAE v5.0, timing of incidence, etc.)
- Serum concentration and pharmacokinetic parameters (AUC, Cmax, etc.) of atezolizumab

Secondary Outcome

Efficacy
- Efficacy in terms of tumor response, duration of response, progression free survival based on RECIST v1.1 and immunogenicity.

Key inclusion & exclusion criteria

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

Include criteria

- Patients with ECOG PS of 0 or 1
- Patients who are expected to survive at least 12 weeks from the start of treatment with the investigational drug
- Patients with histologically or cytologically confirmed solid tumors
- Patients with advanced or recurrent cancer that has not responded to standard of care or patients who are nonresponsive or intolerant to standard of care
- Patients with imaging lesions evaluable by RECIST v1.1

• Exclude criteria: - Patients who have received antibody drugs against CTLA-4, PD-1, or PD-L1 in the past and discontinued them because of side effects.

Related Information

• Primary Sponsor: Shunichiro Iwasawa