HMPL-A830 in Solid Tumors
A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A830 in Solid Tumors
This is a first-in-human (FIH), multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A830 in participants with histologically or cytologically confirmed, unresectable, advanced, or metastatic solid tumors*, who are refractory or progressed on/after available standard treatment. The study will be conducted in 2 parts:
Dose Escalation (Part A, Phase I), approximately 57 participants will be enrolled.
Dose Optimization (Part B, Phase IIa), approximately 90 participants will be enrolled.
調査の概要
詳細な説明
Part A: To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for optimization (RDO) of HMPL-A830 in previously treated participants with solid tumors.
Part B: To characterize the safety, tolerability, and preliminary efficacy of HMPL-A830 at RDO(s) to determine recommended dose(s) for phase 2 (RP2D) or phase 3 (RP3D) in participants with selected solid tumors
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
-
-
-
Beijing、中国
- Beijing Cancer Hospital
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コンタクト：
- Lin Shen
-
Changsha、中国
- Hunan Cancer Hospital
-
コンタクト：
- Yongchang Zhang
-
Chengdu、中国
- West China Hospital of Sichuan University
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コンタクト：
- Li Zheng
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Guangzhou、中国
- The Sixth Affiliated Hospital,Sun Yat-sen University
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コンタクト：
- Yanhong Deng
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Jinan、中国
- Shandong Cancer Hospital
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コンタクト：
- shuqin Ni
-
Nanjing、中国
- Jiangsu Province Hospital
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コンタクト：
- Xiaofeng Chen
-
Taiyuan、中国
- Shanxi Provincial Cancer Hospitial
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コンタクト：
- Hongxia Lu
-
-
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:
- Understood this study and are able to voluntarily sign the informed consent form (ICF);
- Male or Female, Age ≥ 18 years;
- Histological confirmed, unresectable, advanced or metastatic solid tumor
- Participants must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
- Life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
Exclusion Criteria:
- Use strong inhibitors of cytochrome P450 3A4 enzyme (CYP3A4), and inhibitors of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) within 5 elimination half-lives or 2 weeks (whichever is longer) before the first dose of study drug
- Major surgery within 28 days prior to the first dose of study drug
- Active infection requiring systemic treatment
- History of inflammatory gastrointestinal diseases
- Known hypersensitivity to any component of HMPL-A830
- Pregnant (positive pregnancy test) or lactating;
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：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：Part A (Dose Escalation)
|
Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6 predefined dose levels
Participants will be randomized in a 1:1 ratio to receive treatment in two RDO levels.
Randomization will be stratified by tumor types.
|
|
実験的：Part B (Dose Optimization)
|
Enrolled participants with solid tumors will receive HMPL-A830 treatment in a dose escalation setting at 6 predefined dose levels
Participants will be randomized in a 1:1 ratio to receive treatment in two RDO levels.
Randomization will be stratified by tumor types.
|
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 |
|---|---|---|
|
DLTs
時間枠：Approximately 12 months
|
Number of Participants With of DLTs
|
Approximately 12 months
|
|
Overview of Treatment-emergent Adverse Events (TEAEs)
時間枠：Approximately 12 months
|
The number of participants with Adverse Events and Treatment-Related Adverse Events as Assessed by CTCAE v6.0
|
Approximately 12 months
|
|
Objective Response Rate (ORR)
時間枠：Approximately 24 months
|
Assessed by investigators according to RECIST 1.1
|
Approximately 24 months
|
|
Recommended doses for phase II or III studies (RP2D or RP3D)
時間枠：Approximately 12 months
|
The RP2D or RP3D will be selected by evaluating all available data from the following criteria under consideration: Determination of MTD achieved during the dose escalation part; Safety data obtained across all different doses tested; Tolerability data; PK data; efficacy data.
|
Approximately 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
無増悪生存期間 (PFS)
時間枠：約2年
|
研究薬の初回投与から、RECIST v1.1に基づく初回画像診断上の疾患進行（PD）またはあらゆる原因による死亡のいずれか早く発生した日までの期間
|
約2年
|
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Disease control rate (DCR)
時間枠：Approximately 2 years
|
The DCR by RECIST 1.1
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Approximately 2 years
|
|
Pharmacokinetic Analysis(Cmax)
時間枠：Approximately 2 years
|
Maximum plasma concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
|
Approximately 2 years
|
|
Pharmacokinetic Analysis (Cmin)
時間枠：Approximately 2 years
|
Trough concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
|
Approximately 2 years
|
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Pharmacokinetic Analysis(Tmax)
時間枠：Approximately 2 years
|
Time to reach maximum concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
|
Approximately 2 years
|
|
Pharmacokinetic Analysis((AUClast)
時間枠：Approximately 2 years
|
Area under concentration-time curve from time zero to the last measurable concentration for HMPL-A830 (antibody drug conjugate, total antibody and payload)
|
Approximately 2 years
|
|
Pharmacokinetic Analysis((AUCtau)
時間枠：Approximately 2 years
|
Area under concentration-time curve from time zero to the end of the dosing interval for HMPL-A830 (antibody drug conjugate, total antibody and payload)
|
Approximately 2 years
|
|
Incidence of anti-drug antibodies (ADAs) against HMPL-A830
時間枠：Approximately 2 years
|
Number and percentage of patients developing anti-HMPL-A830 antibodies, and semiquantitative titer assessment.
|
Approximately 2 years
|
協力者と研究者
スポンサー
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
本研究に関する用語
その他の研究ID番号
- 2026-830-GLOB1
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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固形腫瘍、成人の臨床試験
-
AstraZeneca積極的、募集していないAdv Solid Malig - H&N SCC、ATM Pro / Def NSCLC、胃がん、乳がん、卵巣がんアメリカ, フランス, イギリス, 韓国
HMPL-A830の臨床試験
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Hutchison Medipharma Limited完了
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Hutchison Medipharma LimitedSun Yat-sen University; Fudan University完了
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Hutchison Medipharma LimitedFudan University; Eighty-One Hospital of People's Liberation Army完了