Phase 1 study of Tobemstomig in patients with advanced solid tumors

JRCT ID: jRCT2031230196

Registered date:01/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: solid tumors
• Date of first enrollment: 29/08/2023
• Target sample size: 18
• Study type: Interventional

Intervention(s)

Tobemstomig: On Day 1 of each cycle, at least 600 mg/body of Tobemstomig is administered by intravenous drip infusion. Each cycle consists of 14 or 21 days.
Tiragolumab: On Day 1 of each cycle, 600 mg/body of Tiragolumab is administered by intravenous drip infusion. Each cycle consists of 21 days.

Outcome(s)

Primary Outcome

safety, phamacokinetics, other
Dose limiting toxicity(DLT)
NCI CTCAE v5.0

Secondary Outcome

efficacy
RECIST v1.1

Key inclusion & exclusion criteria

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

Include criteria

- ECOG PS of 0 or 1
- Life expectancy for at least 12 weeks
- Histologically or cytologically confirmed solid tumor
- Failure to respond to, or not suitable for, standard therapy, or progression/recurrence of cancer without established standard therapy
- Patients with imaging lesions evaluable by RECIST v1.1

Exclude criteria

- Pregnant or lactating patients
- Patients with symptomatic or treated central nervous system tumor or metastases to the central nervous system
- Patients with spinal cord compression lesions
- Patients with significant cardiovascular disease
- Patients with significant liver disease
- HIV, active HBV, active HCV positive
- Dementia or altered mental status that would preclude obtaining informed consent
- Pleural effusion, pericardial effusion, or ascites requiring drainage.
- Patients with significant autoimmune disease or immunodeficiency

Related Information

• Primary Sponsor: Noriko Yanagitani