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Phase I study of RO7187797 in patients with Multiple myeloma.

Phase I study of RO7187797 in patients with Multiple myeloma.

Nanki Toshihiro

Division of Rheumatology, Department of Internal Medicine, School of Medicine, Toho University

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

+81-120-189-706

clinical-trials@chugai-pharm.co.jp

Not Recruiting

Sept. 30, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Eastern Cooperative Oncology Group(ECOG)Performance Status (PS) is 0 or 1.
Survival of at least 12 weeks after the date of enrollment was judged to be possible.
Relapsed/refractory multiple myeloma for which standard therapy is ineffective and inappropriate.

They have a history of the following immune-mediated side effects of previous immunotherapy:
Adverse events Grade 3 or more observed with treatment with anti PD-L1, anti PD-1, or anti CTLA4 therapeutic Abs. Except for Grade 3 endocrine disorders that can be managed with alternative therapies
Allogeneic stem cell transplantation was performed in the past.
Plasma cell count in peripheral blood exceeds 500/micro liter or plasma cell ratio in differential white blood cell count exceeds 5%.

Both

Multiple myeloma

Cevostamab: Cevostamab will be administered intravenously on a 21-day cycle, up to a total of 17 cycles.
Tocilizumab: Intravenous infusion of 8 mg / kg (patient weight 30 kg or more) or 12 mg / kg (patient weight less than 30 kg) at a time.

Safety, Phamacokinetics
Adverse events
Dose limiting toxicity
pharmacokinetic parameters

Efficacy, Other
Response Rates Based on Global Myeloma Working Group (IMWG) Criteria
RO7187797 of anti-drug Abs (ADAs)

+81-86-294-9911

June. 22, 2022

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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