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Phase 1 study of Tobemstomig in patients with advanced solid tumors

Phase 1 study of Tobemstomig in patients with advanced solid tumors

Iwasa Satoru

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

+81-120189706

clinical-trials@chugai-pharm.co.jp

Complete

Aug. 07, 2023

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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

- 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

Both

solid tumors

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.

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

efficacy
RECIST v1.1

+81-3-3542-2511

July. 14, 2023

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

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