Phase 1 study of Tobemstomig in patients with advanced solid tumors

Phase 1

Recruiting

• Conditions: solid tumors

• Registration Number: JPRN-jRCT2031230196
• Lead Sponsor: oriko Yanagitani

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety, phamacokinetics, other<br>Dose limiting toxicity(DLT)<br>NCI CTCAE v5.0

Secondary Outcome Measures

Name	Time	Method
efficacy<br>RECIST v1.1