A Phase I Study of JSKN021 in Advanced Solid Tumors
2026年8月24日 更新者：Jiangsu Alphamab Biopharmaceuticals Co., Ltd
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of JSKN021 in Advanced Malignant Solid Tumors
This is a Phase I, open-label, multi-center, first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profiles, and the preliminary antitumor activity of JSKN021 in advanced malignant solid tumors.
調査の概要
研究の種類
介入
入学 (推定)
199
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jian Zhang, MD
- 電話番号：08602134778299
- メール：syner2000@163.com
研究場所
-
-
Fujian
-
Fuzhou、Fujian、中国、350014
- 募集
- Fujian Cancer Hospital
-
-
Guangxi
-
Nanning、Guangxi、中国
- 募集
- Tumor Hospital of Guangxi Medical University
-
-
Heilongjiang
-
Harbin、Heilongjiang、中国、150081
- 募集
- Harbin Medical University Cancer Hospital
-
-
Hubei
-
Wuhan、Hubei、中国
- 募集
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Wuhan、Hubei、中国、430079
- 募集
- Hubei Cancer Hospital
-
-
Jiangsu
-
Nanjing、Jiangsu、中国
- 募集
- Jiangsu Province Hospital
-
Xuzhou、Jiangsu、中国
- 募集
- Xuzhou Central Hospital
-
-
Shandong
-
Jining、Shandong、中国
- 募集
- Affiliated Hospital of Jining Medical College
-
-
Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国
- 募集
- Fudan University Shanghai Cancer Center
-
-
Tianjin Municipality
-
Tianjin、Tianjin Municipality、中国、300060
- 募集
- Tianjin Medical University Cancer Institute & Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Voluntarily participate and sign the informed consent form.
- Age ≥ 18 years old, male or female.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
- Expected survival ≥ 3 months.
- Histologically or cytologically confirmed malignant solid tumors confirmed by histology and/or cytology, who have failed previous standard treatment (disease progression), are intolerant to standard treatment, or have no access to standard treatment.
- At least one measurable lesion at baseline according to RECIST 1.1 criteria.
- Adequate organ function.
- Female subjects of childbearing potential or male subjects whose partners are of childbearing potential agree to use effective contraceptive measures.
- Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose.
- Be able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.
- Adequate washout period of previous therapy before the first dose.
Exclusion Criteria:
- Complicated with other malignant tumors within 3 years before the first dose.
- History of brainstem, meningeal metastasis, spinal cord metastasis or compression, or carcinomatous meningitis; presence of active brain metastasis.
- Screening imaging shows tumor invasion, compression, or occurrence in surrounding important organs or risk of esophagotracheal fistula or esophagopleural fistula.
- Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
- Presence of the risk factors related to interstitial lung disease (ILD) or non-infectious pneumonia:
- Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
- Uncontrolled infection.
- Received live vaccines within 28 days before the first dose, or plan to receive live vaccines during the study period.
- Toxicity of previous anti-tumor treatment has not fully or partially recovered.
- Known allergy to any component of the study drug, or history of severe allergic reactions to other antibody drugs.
- Pregnant and/or lactating women, or planning to become pregnant during the study period.
- Known history of mental illness, substance abuse, alcoholism, etc., or other situations that the investigator deems may affect the safety or compliance of the study drug treatment.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：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：用量漸増コホート2
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
実験的：用量増量コホート3
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
実験的：用量増量コホート4
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
実験的：用量漸増コホート5
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
実験的：用量漸増コホート6
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
実験的：Dose escalation cohort 1
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
実験的：Dose optimization cohort 1
|
JSKN021 administered intravenously at selected dose levels according to protocol
|
|
実験的：Dose optimization cohort 2
|
JSKN021 administered intravenously at selected dose levels according to 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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc (Safety and tolerability of JSKN021)
時間枠：From the first dose to 30 days after the last dose or until initiation of new anti-tumor treatment, whichever comes first.
|
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), etc.; abnormalities in physical examinations, laboratory tests, electrocardiograms, and other safety measures.
|
From the first dose to 30 days after the last dose or until initiation of new anti-tumor treatment, whichever comes first.
|
|
Dose-limiting toxicity (DLT)
時間枠：21 days from the first dose
|
Incidence of dose-limiting toxicity (DLT) in each dose group.
|
21 days from the first dose
|
|
Optimal biological dose (OBD) and/or recommended Phase Ⅱ dose (RP2D) of JSKN021.
時間枠：Up to 24 months
|
Based on safety and efficacy data.
|
Up to 24 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Objective response rate (ORR)
時間枠：Up to 24months
|
Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response [CR] or partial response [PR] per Response Evaluation Criteria in Solid Tumors (RECIST v1.1）
|
Up to 24months
|
|
Duration of response (DoR)
時間枠：Up to 24months
|
Duration of response (DoR) assessed according to RECIST v1.1.
|
Up to 24months
|
|
Disease control rate (DCR)
時間枠：Up to 24months
|
Disease control rate (DCR) assessed according to RECIST v1.1.
|
Up to 24months
|
|
Progression-Free Survival (PFS)
時間枠：Up to 24months
|
Progression-free survival (PFS) is defined as the time from the date of initial administration till the first documentation of disease progression or death due to any cause (whichever occurs first).
|
Up to 24months
|
|
Overall survival(OS)
時間枠：Up to 24months
|
Overall Survival (OS) is defined as the time from the date of initial administration till death due to any cause.
|
Up to 24months
|
|
Immunogenicity
時間枠：Up to 24months
|
Incidence and titer changes of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs, if applicable)
|
Up to 24months
|
|
Maximum concentration (Cmax) of JSKN021
時間枠：Up to 24months
|
Maximum concentration (Cmax) of JSKN021
|
Up to 24months
|
|
Time to maximum concentration (Tmax) of JSKN021
時間枠：Up to 24 months.
|
Time to maximum concentration (Tmax) of JSKN021
|
Up to 24 months.
|
|
Trough concentration (Ctrough) of JSKN021
時間枠：Up to 24 months
|
Trough concentration (Ctrough) of JSKN021
|
Up to 24 months
|
|
Area under the concentration-time curve of JSKN021
時間枠：Up to 24 months
|
Area under the concentration-time curve of JSKN021
|
Up to 24 months
|
|
Volume of distribution (V) of JSKN021
時間枠：Up to 24 months
|
Volume of distribution (V) of JSKN021
|
Up to 24 months
|
|
Elimination half-life (t1/2) of JSKN021
時間枠：Up to 24 months
|
Elimination half-life (t1/2) of JSKN021
|
Up to 24 months
|
|
Clearance (CL) of JSKN021
時間枠：Up to 24 months
|
Clearance (CL) of JSKN021
|
Up to 24 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月2日
一次修了 (推定)
2028年10月31日
研究の完了 (推定)
2029年5月31日
試験登録日
最初に提出
2026年5月20日
QC基準を満たした最初の提出物
2026年5月29日
最初の投稿 (実際)
2026年6月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月26日
QC基準を満たした最後の更新が送信されました
2026年8月24日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
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?
いいえ
IPD プランの説明
No individual participant data will be shared.
The informed consent form does not include provisions for sharing de-identified participant-level data with researchers outside the study team.
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
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。