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
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
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
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
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・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
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
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
捜査官
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)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- GO46451
- 2026-526130-15-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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