Phase 1 Study of MST-168 in Participants With Advanced Solid Malignant Tumors
A Phase 1, Multiregional, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MST-168, in Participants With Advanced Solid Malignant Tumors
A Phase 1, multiregional, open-label study of MST-168 in participants with target-driven advanced solid tumors.
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic effects, and preliminary efficacy of MST-168 in participants with target-driven advanced solid tumors. MST-168 is an investigational ADC.
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
研究連絡先
- 名前：Changlong Liu
- 電話番号：+86-15810213012
- メール：changlong.liu@mabsoftbio.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Participants are eligible to be included in the study only if all of the following criteria apply:
I1. Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in this protocol.
I2. Is at least 18 years of age at the time of signing the ICF.
I3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
I4. Life expectancy ≥ 12 weeks.
I5. Has adequate organ function.
I6. Pregnancy and Contraception: Female participants agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment. Male participants with partners of childbearing potential and female participants of childbearing potential are willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy from beginning of the study screening until 6 months after receiving the last treatment of MST-168.
I7. Has a pathologically documented advanced/unresectable or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Exclusion Criteria:
- Participants are excluded from the study if any of the following criteria apply:
E1. Has untreated brain or CNS metastases or brain/CNS metastases that have progressed [e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain/CNS metastases]. Participants with previously unstable brain or CNS metastases.
E2. Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.
E3. Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
E4. Has known sensitivity to study intervention components or excipients.
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：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：MST-168 initial dose level treatment Cohort
MST-168 initial dose level
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
実験的：MST-168 dose level 2 treatment Cohort
MST-168 dose level 2
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
実験的：MST-168 dose level 3 treatment Cohort
MST-168 dose level 3
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
実験的：MST-168 dose level 4 treatment Cohort
MST-168 dose level 4
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
実験的：MST-168 dose level 5 treatment Cohort
MST-168 dose level 5
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
実験的：MST-168 dose level 6 treatment Cohort
MST-168 dose level 6, if needed
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
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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 |
|---|---|
|
Incidence of dose-limiting toxicities (DLT)
時間枠：Day 1 - Day 28
|
Day 1 - Day 28
|
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Incidence and severity of AEs, clinically significant changes from Baseline (pre-dose on D1) through to the EOT in vital signs, laboratory tests, physical examinations, 12-lead ECG, and ECHO/MUGA.
時間枠：Through study completion, up to 25 months
|
Through study completion, up to 25 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Tmax
時間枠：Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Cmax
時間枠：Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-t
時間枠：Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-∞
時間枠：Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: t1/2
時間枠：Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: CL
時間枠：Day 1 to Day 8
|
Day 1 to Day 8
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Vss
時間枠：Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: AUCss
時間枠：Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
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PK parameters for MST-168, total anti-drug antibody and free payload: Css,max
時間枠：Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Css,min
時間枠：Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Frequencies of ADAs and neutralizing antibodies specific to MST-168.
時間枠：Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Biomarkers: cytokines/chemokines and immune cell phenotypes
時間枠：Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Objective response rate (ORR) based on RECIST v1.1.
時間枠：Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Duration of response (DoR) based on RECIST v1.1.
時間枠：Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Progression-free survival (PFS) based on RECIST v1.1.
時間枠：Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Disease control rate (DCR) based on RECIST v1.1.
時間枠：Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
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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