CW-301 FIH Study of CAN016
2026年6月29日 更新者：Canwell Biotech Limited
A Phase I/II, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients With Advanced Solid Tumors
A Phase I/II, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients with Advanced Solid Tumors
調査の概要
詳細な説明
This is a Phase I/II, Open-Label, Non-Randomized, Multi-centre First-in-Human Study.
Phase I:
Accelerated Titration Designs and 3+3 escalation design for MTD and/or RP2D determination.
Phase II:
Once the RP2D is determined, the study will enroll patients into Phase II. Approximately 20~60 patients will be enrolled to evaluate the efficacy of CAN016 in HER2 expression or mutation advanced solid tumors.
研究の種類
介入
入学 (推定)
90
段階
- フェーズ2
- 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：Binghe Xu, MD,PhD
- 電話番号：+86 010-67781331
- メール：xubinghe@medmail.com.cn
研究場所
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100021
- 募集
- Cancer Hospital Chinese Academy of Medical Sciences
-
コンタクト：
- Binghe Xu, MD,PhD
- 電話番号：+86 010-67781331
- メール：xubinghe@medmail.com.cn
-
-
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:
- Provide informed consent voluntarily
- Male or female patients ≥18 years of age.
Patients must have a histologically or cytologically confirmed diagnosis of recurrent or metastatic HER2 expression or mutation advanced solid tumor that has failed to or intolerable with standard treatment.
- For Phase I dose escalation, patients must have had progression of disease on an HER2 targeted ADC and should be refractory to or intolerant of exiting therapy(ies) known to provide clinical benefit for their condition;
- For Phase II, patients with advanced/unresectable or metastatic HER2 positive (IHC 3+, 2+/ISH+) breast cancer, HER2 low/ultralow expression (IHC 1+, 2+/ISH-, IHC 0 with membrane staining) breast cancer and other HER2 expression or mutation advanced solid tumors are eligible. Patients must have had progression of disease on prior HER2 targeted ADC.
- At least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Adequate organ function with 7 days before registration
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
- LVEF ≥50% by either echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before registration.
- Life expectancy of ≥3 months.
Exclusion Criteria
- Patient has received any anticancer therapy (including chemotherapy, targeted therapy, hormonal therapy, biotherapy, immunotherapy, or other investigational agents.) within 28 days or 5 times of half-lives (whichever is shorter) prior to the first dose of the study treatment or who have not recovered from the side effect of such therapy.
- Radical radiation therapy (including radiation therapy for over 25% bone marrow) within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.
- Patients have autologous transplantation within 3 months.
- Major surgery or had significant traumatic injury within 60 days prior to the first dose of the investigational product or has not recovered from major side effects.
- Multiple primary malignancies within 5 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease.
- Any toxicities from prior treatment that have not recovered to baseline or ≤CTCAE Grade 1 before the start of study treatment, with exception of hair loss.
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：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：patients with advanced/unresectable or metastatic HER2 positive (IHC 3+, 2+/ISH+) breast cancer
CAN016
|
CAN016 will be administered intravenously into each patient on Day 1 of Cycle 1. Patients will continue to receive CAN016 Q3W until unacceptable toxicity, progressive disease, or withdrawal of consent, death, lost to F/U, or other discontinuation criteria is met.
an initial dose of CAN016 0.75 mg/kg will be administered intravenously into each patient for approximately 90 minutes on Day 1 of Cycle 1.
A 21-day observation period (Cycle 1) will then occur as DLT period, at the end of which all relevant safety data will be reviewed.
Upon completion of cycle 1, patients will continue to receive CAN016 once every 3 weeks (Q3W, unless the pharmacokinetic data suggests a different schedule of administration) until unacceptable toxicity, progressive disease (PD), or withdrawal of consent, death, lost to follow-up (F/U), or other discontinuation criteria is met
|
|
実験的：HER2 low/ultralow expression (IHC 1+, 2+/ISH-, IHC 0 with membrane staining) breast cancer
CAN016
|
CAN016 will be administered intravenously into each patient on Day 1 of Cycle 1. Patients will continue to receive CAN016 Q3W until unacceptable toxicity, progressive disease, or withdrawal of consent, death, lost to F/U, or other discontinuation criteria is met.
an initial dose of CAN016 0.75 mg/kg will be administered intravenously into each patient for approximately 90 minutes on Day 1 of Cycle 1.
A 21-day observation period (Cycle 1) will then occur as DLT period, at the end of which all relevant safety data will be reviewed.
Upon completion of cycle 1, patients will continue to receive CAN016 once every 3 weeks (Q3W, unless the pharmacokinetic data suggests a different schedule of administration) until unacceptable toxicity, progressive disease (PD), or withdrawal of consent, death, lost to follow-up (F/U), or other discontinuation criteria is met
|
|
実験的：HER2 expression or mutation advanced solid tumors
CAN016
|
CAN016 will be administered intravenously into each patient on Day 1 of Cycle 1. Patients will continue to receive CAN016 Q3W until unacceptable toxicity, progressive disease, or withdrawal of consent, death, lost to F/U, or other discontinuation criteria is met.
an initial dose of CAN016 0.75 mg/kg will be administered intravenously into each patient for approximately 90 minutes on Day 1 of Cycle 1.
A 21-day observation period (Cycle 1) will then occur as DLT period, at the end of which all relevant safety data will be reviewed.
Upon completion of cycle 1, patients will continue to receive CAN016 once every 3 weeks (Q3W, unless the pharmacokinetic data suggests a different schedule of administration) until unacceptable toxicity, progressive disease (PD), or withdrawal of consent, death, lost to follow-up (F/U), or other discontinuation criteria is met
|
|
実験的：For Phase I dose escalation, patients must have had progression of disease on an HER2 targeted AD
CAN016
|
CAN016 will be administered intravenously into each patient on Day 1 of Cycle 1. Patients will continue to receive CAN016 Q3W until unacceptable toxicity, progressive disease, or withdrawal of consent, death, lost to F/U, or other discontinuation criteria is met.
an initial dose of CAN016 0.75 mg/kg will be administered intravenously into each patient for approximately 90 minutes on Day 1 of Cycle 1.
A 21-day observation period (Cycle 1) will then occur as DLT period, at the end of which all relevant safety data will be reviewed.
Upon completion of cycle 1, patients will continue to receive CAN016 once every 3 weeks (Q3W, unless the pharmacokinetic data suggests a different schedule of administration) until unacceptable toxicity, progressive disease (PD), or withdrawal of consent, death, lost to follow-up (F/U), or other discontinuation criteria is met
|
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 |
|---|---|---|
|
Dose Limiting Toxicities (DLT)
時間枠：12 months
|
Incidence rate of dose limiting toxicities (DLT) in the first cycle (of 21 days) of each investigated dose levels.
|
12 months
|
|
Tumor objective response rate (ORR)
時間枠：36 months
|
Tumor objective response rate (ORR) defined as the sum of complete response (CR) rate and partial response (PR) rate as best reported by Response Evaluation Criteria in Solid Tumors (RECIST1.1)
|
36 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety and Tolerability
時間枠：48 months
|
AE type, incidence, duration, severity and seriousness of AEs, physical examination, laboratory data, vital signs and ECG changes according to Common Terminology Criteria for Adverse Event (CTCAE) version 5.0.
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48 months
|
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Pharmacokinetic measures - concentration time Area Under the Curves
時間枠：12 months
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Measure the variation of CAN016 concentration in blood as a function time
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12 months
|
|
Pharmacokinetic measures - Cmax
時間枠：12 months
|
Measure the maximum (peak) blood concentration(s) of CAN016
|
12 months
|
|
Pharmacokinetic measures - Tmax
時間枠：12 months
|
Measure of time to reach maximum (peak) blood concentration(s) following administration of CAN016
|
12 months
|
|
Pharmacokinetic measures - terminal half- life (t1/2)
時間枠：12 months
|
Measure elimination half-life of CAN016, when administered
|
12 months
|
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Pharmacokinetic measures - Vd
時間枠：12 months
|
Measure the volume of distribution after administration of CAN016.
|
12 months
|
|
Pharmacokinetic measures - CL
時間枠：12 months
|
Measure apparent total clearance(s) of CAN016 from blood after administration
|
12 months
|
|
Immunogenicity of CAN016
時間枠：48 months
|
Measure the incidence of anti-drug antibody (ADA) against CAN016
|
48 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。
スポンサー
捜査官
- 主任研究者：Binghe Xu, MD,PhD、Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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 (推定)
2026年6月18日
一次修了 (推定)
2028年12月30日
研究の完了 (推定)
2029年12月30日
試験登録日
最初に提出
2026年6月14日
QC基準を満たした最初の提出物
2026年6月17日
最初の投稿 (実際)
2026年6月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月1日
QC基準を満たした最後の更新が送信されました
2026年6月29日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- CW-301
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
はい
米国FDA規制機器製品の研究
いいえ
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