A Clinical Study to Evaluate the Effects of RO7875913 in Healthy Participants and of RO7875913 With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma
健康なボランティアにおけるRO7875913の安全性、薬物動態、および薬力学を評価する第I相用量漸増試験
Part A: The purpose of Part A of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of RO7875913 in healthy participants.
Part B: The purpose of Part B of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RO7875913 administered in combination with the T cell-engaging bispecific antibody (TCB) cevostamab in participants with relapsed or refractory (R/R) multiple myeloma (MM).
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Canterbury
-
Christchurch、Canterbury、ニュージーランド、8011
- New Zealand Clinical Research - Christchurch
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
General:
- Agreement to adhere to the contraception requirements
Part A:
- Body weight > 40 kilogram (kg) with a body mass index of 18-30 kg per meter square (kg/m^2)
Part B:
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- Agreement to provide bone marrow biopsy and aspirate samples
Exclusion Criteria:
General:
- Treatment with any vaccine within 4 weeks prior to initiation of study drug, or vaccination scheduled to occur during the study
- History or current cardiovascular or pulmonary disease that may limit the ability to respond to systemic infusion/injection reactions
- Positive test result for hepatitis B surface antigen, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibody screen
- History of any malignancy
- Major surgical procedure within 28 days prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, hematologic, gastrointestinal, urologic, neurologic, or psychiatric disorders
- Known allergy or hypersensitivity to any component of the RO7875913 formulation
Part A:
- Treatment with investigational biologic therapy (or blinded comparator) within 90 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug
- Treatment with investigational non-biologic therapy (or blinded comparator) within 28 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug
- Clinically apparent or familial history of autoimmune disease
Part B:
- Treatment with any systemic chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment
- Treatment with any immunosuppressive medication within 2 weeks prior to first dose of study treatment
- Absolute plasma cell count exceeding 500/mL or 5% of the peripheral blood white cells
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:順次割り当て
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Part A: RO7875913
Participants will receive RO7875913. |
Participants will receive RO7875913 as per the schedule described in the protocol. |
|
プラセボコンパレーター:Part A: Placebo
Participants will receive placebo. |
Participants will receive placebo as per the schedule described in the protocol. |
|
実験的:Part B: RO7875913 with cevostamab
Participants will recieve RO7875913 with cevostamab. |
Participants will receive RO7875913 as per the schedule described in the protocol. Participants will receive cevostamab as per the schedule described in the protocol |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Part A: Percentage of Participants with Adverse Events (AEs)
時間枠:Up to approximately 3 months
|
Up to approximately 3 months
|
|
Part B: Percentage of Participants with Adverse Events (AEs)
時間枠:Up to approximately 2 years
|
Up to approximately 2 years
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Part A: Serum concentration of RO7875913
時間枠:Up to Day 76
|
Up to Day 76
|
|
Part A: Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7875913 at Baseline and with ADAs to RO7875913 During the Treatment Period
時間枠:Baseline, Up to Day 76
|
Baseline, Up to Day 76
|
|
Part A: Recommended Phase II Dose (RP2D) of RO7875913
時間枠:Up to approximately 3 months
|
Up to approximately 3 months
|
|
Part A: Observed Value of Pharmacodynamic Markers
時間枠:Baseline, up to approximately 3 months
|
Baseline, up to approximately 3 months
|
|
Part B: Serum Concentration of RO7875913
時間枠:Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Serum Concentration of Cevostamab
時間枠:Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Objective Response Rate
時間枠:Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Rate of Complete Response (CR)/ stringent Complete Response (sCR)
時間枠:Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Rate of Very Good Partial Response (VGPR) or Better
時間枠:Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Duration of Response
時間枠:Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Time to First Response
時間枠:Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Time to Best Response
時間枠:Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7875913 at Baseline and with ADAs to RO7875913 During the Treatment Period
時間枠:Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: Percentage of Participants with Anti-Drug Antibodies (ADAs) to Cevostamab at Baseline and with ADAs to RO7875913 During the Treatment Period
時間枠:Up to approximately 2 years
|
Up to approximately 2 years
|
|
Part B: RP2D of the RO7875913 and Cevostamab Combination Regimen
時間枠:Up to approximately 2 years
|
Up to approximately 2 years
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:Clinical Trials、Genentech, Inc.
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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