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進行性/転移性固形腫瘍を有する成人を対象としたNKT3964を用いた研究

2026年11月2日 更新者：NiKang Therapeutics, Inc.

進行性/転移性固形腫瘍を有する成人を対象とした新規経口CDK2分解剤NKT3964の安全性、忍容性、PK、および予備抗腫瘍活性を評価する第1相ファーストインヒト非盲検試験

The goal of the Monotherapy Dose Escalation phase (Part 1) of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors.

The goal of the Monotherapy Expansion phase of the study (Part 2) is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).

The goal of the Combination Dose Escalation phase (Part 3) of the study is to identify the RDE of NKT3964 in combination with chemotherapy in adult subjects with advanced/metastatic endometrial cancer. The goal of the Combination Expansion phase of the study (Part 4) is to evaluate the preliminary anti-tumor activity of NKT3964 in combination with chemotherapy at the RDE based on ORR.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Inclusion Criteria:

- Must have a pathologically confirmed, advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment.

For Part 1 Monotherapy Dose Escalation (including Food Effect Sub-study): Patients must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.

Part 1 Monotherapy Dose Escalation and Food Effect Sub-study:

  1. Ovarian cancer

  2. Endometrial cancer (only 'endometrioid' subtype requires CCNE1 amplification)

  3. Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification

  4. Small cell lung cancer (SCLC)

  5. Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)

  6. HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and is not suitable for endocrine therapy [ET])

  7. Other solid tumors with CCNE1 amplification

    Part 2 Monotherapy Dose Expansion:

    Part 2A: HR+ and HER2- breast cancer that is locally advanced and unresectable (Stage III) or metastatic (Stage IV); previously treated with ≥1 line of SOC including CDK4/6 inhibitor plus ET and not suitable for further ET. Subjects must have progressed after receiving therapy for ≥3 months in the metastatic setting or for ≥6 months in the adjuvant setting. Subjects must have received ≤2 lines of systemic cytotoxic therapy (chemotherapy or cytotoxic antibody drug conjugate) in the metastatic setting.

    Part 2B: Advanced platinum-based chemotherapy- resistant or refractory epithelial ovarian/fallopian/primary peritoneal carcinoma or clear cell ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least one platinum containing therapy and previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease and with CCNE1 amplification.

    Part 2C: Advanced unresectable or metastatic gastric, GEJ or esophageal adenocarcinoma with progression on at least one systemic therapy and previously treated with ≤3 prior lines of systemic therapy administered for advanced/metastatic disease, with CCNE1 amplification.

    Part 2D: Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease with CCNE1 amplification. Subjects with clear cell carcinoma or uterine serous carcinoma histology may be considered regardless of CCNE1 status after discussion and approval from the Sponsor.

    Part 2E: Advanced/recurrent uterine carcinosarcoma previously treated with 1 prior platinum-based chemotherapy regimen and ≤3 prior lines of systemic therapy. Prior bevacizumab or PARP inhibitors are allowed and must be at least 3 weeks prior to the start of study drug.

    Part 3 Combination Dose Escalation: Subjects must be refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition

    • Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease with CCNE1 amplification.

    • Subjects with clear cell carcinoma or uterine serous carcinoma histology may be considered regardless of CCNE1 status after discussion and approval from the Sponsor

    Part 4 Combination Dose Expansion:

    • Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease with CCNE1 amplification.

    - Subjects with clear cell carcinoma or uterine serous carcinoma histology may be considered regardless of CCNE1 status after discussion and approval from the Sponsor

    - Measurable disease per RECIST v1.1, except for subjects with HR+/HER2- breast cancer or endometrial cancer (Part 1) who must have measurable or evaluable (including skin or bone lesion only) disease.

    - Age ≥19 years

    - ECOG PS 0-1

    - Have adequate organ function

    - Subjects with female reproductive organs must be surgically sterile, post-menopausal, or, if of child-bearing potential, must meet pre-specified criteria

    - Subjects who are capable of insemination must meet pre-specified criteria

    - Ability to swallow oral medications.

    - Consent to provide archived tumor tissues and paired tumor biopsy at pretreatment and on-treatment.

    Exclusion Criteria:

    -Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy.

    -History of another malignancy with exceptions

    -History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.

    -Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)

    -Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment

    -Known active CNS metastases and/or carcinomatous meningitis

    -Clinically active interstitial lung disease currently requiring treatment

    -History of uveitis, retinopathy or other clinically significant retinal disease

    -Active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease

    -Active wound healing from major surgery within 1 month or minor surgery within 10 days before the first dose of NKT3964.

    -Known human immunodeficiency virus (HIV), active hepatitis B or C infection

    -Prior investigative treatment with a selective or nonselective CDK2 inhibitor or degrader

    • Childs-Pugh class B or C cirrhosis or any other clinically significant liver disorder

    • Palliative radiation therapy within 14 days or other radiation therapy within 4 weeks prior to C1D1

    • Prior severe hypersensitivity reaction to paclitaxel or other drugs formulated in Polyoxyl 35 Castor Oil (Cohort 3A and 4A only) or severe hypersensitivity reaction to doxorubicin or any other component of the product, other anthracyclines or anthracenediones (Cohort 3B and 4B only).

    • For subjects in Cohort 3B or 4B only:

      • Left ventricular ejection fraction (LVEF) <50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 4 weeks prior to first dose

      • Active cardiac conditions including myocarditis, pericarditis, or clinically significant valvular heart disease

      • Known elevated cardiac biomarkers at baseline

      • History of anthracycline-related cardiomyopathy regardless of recovery
      • Cumulative lifetime exposure to doxorubicin, including planned doxorubicin in Part 3b or Part 4b, exceeding 450 mg/m2

研究の種類

介入

入学 (推定)

238

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

研究場所

  • アメリカ
    • Arkansas
      • Little Rock、Arkansas、アメリカ、72205
        • 募集
        • University of Arkansas Medical School
        • 主任研究者：
          • Michael Birrer, MD
        • コンタクト：
    • California
      • Los Angeles、California、アメリカ、90095
        • 募集
        • University of California - Los Angeles
        • 主任研究者：
          • Gottfried Konecny, MD
        • コンタクト：
      • San Francisco、California、アメリカ、94158
        • 引きこもった
        • UCSF
    • Colorado
      • Denver、Colorado、アメリカ、80218
    • Florida
      • Lake Mary、Florida、アメリカ、32746
        • 終了しました
        • Florida Cancer Specialists & Research Institute
      • Orlando、Florida、アメリカ、32804
        • 募集
        • AdventHealth Cancer Institute
        • 主任研究者：
          • Robert Holloway, MD
        • コンタクト：
    • Georgia
      • Atlanta、Georgia、アメリカ、30322
        • 募集
        • Emory Winship Cancer Institute
        • 主任研究者：
          • Beryl Manning-Geist, MD
        • コンタクト：
      • Augusta、Georgia、アメリカ、30912
        • 募集
        • Augusta University
        • 主任研究者：
          • Bunja Rungruang, MD
    • Kansas
      • Fairway、Kansas、アメリカ、66205
        • 引きこもった
        • University of Kansas
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02215
        • 募集
        • Dana Farber Cancer Institute
        • コンタクト：
        • 主任研究者：
          • Elizabeth LEE, MD
    • New Jersey
      • Hackensack、New Jersey、アメリカ、07601
        • 募集
        • John Theurer Cancer Center at Hackensack UMC
        • 主任研究者：
          • Martin Gutierrez, MD
        • コンタクト：
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19107
        • 募集
        • Sidney Kimmell Cancer Center - Jefferson Health
        • コンタクト：
          • Sarah Cannon Research Institute
          • 電話番号：844-482-4812
        • 主任研究者：
          • Ida Micaily, MD
      • Pittsburgh、Pennsylvania、アメリカ、15213
        • 引きこもった
        • UPMC
    • Tennessee
      • Nashville、Tennessee、アメリカ、37203
        • 募集
        • Sarah Cannon Research Institute (SCRI)
        • 主任研究者：
          • Denise Yardley, MD
        • コンタクト：
    • Texas
      • Austin、Texas、アメリカ、78758
        • 募集
        • NEXT Oncology
        • コンタクト：
        • 主任研究者：
          • Sheena Sahota, MD
      • Dallas、Texas、アメリカ、75235
    • Utah
      • Salt Lake City、Utah、アメリカ、84145
        • 募集
        • Intermountain Health
        • コンタクト：
        • 主任研究者：
          • Caroline Nebhan, MD
    • Virginia
      • Charlottesville、Virginia、アメリカ、22903
        • 募集
        • University of Virginia
        • 主任研究者：
          • Linda Duska, MD
        • コンタクト：
      • Fairfax、Virginia、アメリカ、22031
        • 募集
        • NEXT Virginia
        • 主任研究者：
          • Alexander Spira, MD
        • コンタクト：
  • 韓国
      • Seoul、韓国、03722
        • 募集
        • Yonsei Cancer Center / Severance Hospital
        • 主任研究者：
          • Jung-Yun Lee, MD
        • コンタクト：
          • Severance Hospital IRB
          • 電話番号：+82-02-2228-0430
          • メール：irb@yuhs.ac
    • Gyeonggi-do
      • Gwangmyeong、Gyeonggi-do、韓国、14353
        • 募集
        • Chung-Ang University Gwangmyeong Hospital
        • 主任研究者：
          • Byoung-Gie Kim, MD
        • コンタクト：

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

19年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 Monotherapy Dose Escalation (including Food Effect Sub-study): subjects must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.

Part 1 Monotherapy Dose Escalation:

  1. Ovarian cancer

  2. Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)

  3. Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification

  4. Small cell lung cancer (SCLC)

  5. Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)

  6. HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and is not suitable for endocrine therapy [ET])

  7. Other solid tumors with CCNE1 amplification

    • - Part 2 Monotherapy Dose Expansion:
    • Part 2A: HR+ and HER2- breast cancer that is locally advanced and unresectable (Stage III) or metastatic (Stage IV); previously treated with ≥1 line of standard of care (SOC) including CDK4/6 inhibitor plus ET and not suitable for further ET. Subjects must have progressed after receiving therapy for ≥3 months in the metastatic setting or for ≥6 months in the adjuvant setting. Subjects must have received ≤2 lines of systemic cytotoxic therapy (chemotherapy or cytotoxic antibody drug conjugate [ADC]) in the metastatic setting..
    • Part 2B: Advanced platinum-based-chemotherapy resistant or refractory epithelial ovarian/fallopian/primary peritoneal carcinoma or clear cell ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least one platinum containing therapy and previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease and with CCNE1 amplification.
    • Part 2C: Advanced unresectable or metastatic gastric, GEJ or esophageal adenocarcinoma with progression on at least one systemic therapy and previously treated with ≤3 prior lines of systemic therapy administered for advanced/metastatic disease, with CCNE1 amplification.
    • Part 2D: Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease with CCNE1 amplification. Subjects with clear cell carcinoma or uterine serous carcinoma histology may be considered regardless of CCNE1 status after discussion and approval from the Sponsor.
    • Part 2E: Advanced/recurrent uterine carcinosarcoma previously treated with 1 prior platinum-based chemotherapy regimen and ≤3 prior lines of systemic therapy. Prior bevacizumab or PARP inhibitors are allowed and must be at least 3 weeks prior to the start of study drug.
    • -Part 3 Combination Dose Escalation:
    • Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease with CCNE1 amplification. (Subjects with clear cell carcinoma or uterine serous carcinoma histology may be considered regardless of CCNE1 status after discussion and approval from the Sponsor)
    • -Part 4 Combination Dose Expansion:
    • Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease with CCNE1 amplification. (Subjects with clear cell carcinoma or uterine serous carcinoma histology may be considered regardless of CCNE1 status after discussion and approval from the Sponsor)
    • Have adequate organ function
    • Subjects with female reproductive organs must be surgically sterile, post-menopausal, or must be willing to use highly effective method(s) of contraception
    • Ability to swallow oral medications.
    • Consent to provide archived tumor tissues and paired tumor biopsy at pretreatment

Exclusion Criteria:

  • Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy.
  • History of another malignancy with exceptions
  • History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.
  • Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)
  • Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment
  • Known active CNS metastases and/or carcinomatous meningitis
  • Active interstitial lung disease currently requiring treatment
  • History of uveitis, retinopathy or other clinically significant retinal disease
  • Active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease
  • Active wound healing from major surgery within 1 month or minor surgery within 10 days before the first dose of NKT3964.
  • Known human immunodeficiency virus (HIV), active hepatitis B or C infection
  • Prior investigative treatment with a selective or nonselective CDK2 inhibitor or degrader
  • Childs-Pugh class B or C cirrhosis or any other clinically significant liver disorder
  • Palliative radiation therapy within 14 days or other radiation therapy within 4 weeks prior to C1D1
  • Prior severe hypersensitivity reaction to paclitaxel or other drugs formulated in Polyoxyl 35 Castor Oil (Cohort 3A and 4A only) or severe hypersensitivity reaction to doxorubicin or any other component of the product, other anthracyclines or anthracenediones (Cohort 3B and 4B).
  • - For subjects in Cohort 3B or 4B only:
  • Left ventricular ejection fraction (LVEF) <50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 4 weeks prior to first dose
  • Active cardiac conditions including myocarditis, pericarditis, or clinically significant valvular heart disease
  • Known elevated cardiac biomarkers at baseline
  • History of anthracycline-related cardiomyopathy regardless of recovery
  • Cumulative lifetime exposure to doxorubicin, including planned doxorubicin in Part 3b or Part 4b, exceeding 450 mg/m2

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：Monotherapy Dose Expansion 2A

Monotherapy Dose expansion 2A will include the RDE selected to determine the preliminary antitumor activity and the RP2D in HR+/HER2- breast cancer
薬：NKT3964

Oral CDK2 Degrader
実験的：Combination Dose Expansion 4A

Combination Dose expansion 4A will evaluate the preliminary anti-tumor activity of NKT3964 in combination with chemotherapy (Paclitaxel) at the RDE from Part 3 based on ORR
薬：NKT3964

Oral CDK2 Degrader

薬：Paclitaxel

Paclitaxel will be administered on a 3 weeks on, 1 week off schedule at a dose of 80 mg/m2 IV. Subjects will receive a total of 6 cycles of paclitaxel.
実験的：Combination Dose Expansion 4B

Combination Dose expansion 4B will evaluate the preliminary anti-tumor activity of NKT3964 in combination with chemotherapy (Doxorubicin) at the RDE from Part 3 based on ORR
薬：NKT3964

Oral CDK2 Degrader

薬：Doxorubicin

Doxorubicin will be administered every 3 weeks at a dose of 60 mg/m2 IV. Subjects will receive a total of 6 cycles of doxorubicin.
実験的：Monotherapy Dose Expansion 2B

Monotherapy Dose expansion 2B will include the RDE selected to determine the preliminary antitumor activity and the RP2D in CCNE1-amplified ovarian cancer
薬：NKT3964

Oral CDK2 Degrader
実験的：Monotherapy Dose Expansion 2C

Monotherapy Dose expansion 2C will include the RDE selected to determine the preliminary antitumor activity and the RP2D in CCNE1-amplified upper gastrointestinal adenocarcinoma cancer
薬：NKT3964

Oral CDK2 Degrader
実験的：Monotherapy Dose Expansion 2D

Monotherapy Dose expansion 2D will include the RDE selected to determine the preliminary antitumor activity and the RP2D in endometrial cancer
薬：NKT3964

Oral CDK2 Degrader
実験的：Monotherapy Dose Expansion 2E

Monotherapy Dose expansion 2E will include the RDE selected to determine the preliminary antitumor activity and the RP2D in uterine carcinosarcoma
薬：NKT3964

Oral CDK2 Degrader
実験的：Monotherapy Dose Escalation

Dose escalation will assess the safety, efficacy, and PK/PD data of oral dosing NKT3964 at increasing dosage levels to determine the MTD and/or preliminary RDEs.
薬：NKT3964

Oral CDK2 Degrader
実験的：Combination Dose Escalation 3A

Combination Dose escalation Part 3A will evaluate the safety, tolerability, PK, and preliminary antitumor activity as well as determine the MTD and/or the preliminary RDE of NKT3964 in combination with chemotherapy (Paclitaxel) in endometrial cancer.
薬：NKT3964

Oral CDK2 Degrader

薬：Paclitaxel

Paclitaxel will be administered on a 3 weeks on, 1 week off schedule at a dose of 80 mg/m2 IV. Subjects will receive a total of 6 cycles of paclitaxel.
実験的：Combination Dose Escalation 3B

Combination Dose escalation Part 3B will evaluate the safety, tolerability, PK, and preliminary antitumor activity as well as determine the MTD and/or the preliminary RDE of NKT3964 in combination with chemotherapy (Doxorubicin) in endometrial cancer.
薬：NKT3964

Oral CDK2 Degrader

薬：Doxorubicin

Doxorubicin will be administered every 3 weeks at a dose of 60 mg/m2 IV. Subjects will receive a total of 6 cycles of doxorubicin.

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
Number of Participants with Dose Limiting Toxicity (DLT) events
時間枠：28 Days

DLTs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
28 Days
Objective Response Rate (ORR)
時間枠：1 Year

ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as determined by the Investigator
1 Year

二次結果の測定

結果測定
メジャーの説明
時間枠
Progression-free survival (PFS)
時間枠：2 Year

PFS defined as the time from the date the participant started study drug to the date the participant experiences an event of disease progression or death.
2 Year
Duration of Response (DOR)
時間枠：2 Year

Duration of overall response is defined as the time from the date of first confirmed CR or PR, assessed by investigator and based on RECIST v. 1.1, to the documented date of progressive disease (PD) including clinical progression, or death due to any cause, or the start of subsequent anticancer therapy, whichever occurred first.
2 Year
Disease control rate
時間枠：1 Year

Disease control rate defined as CR + PR + stable disease [SD] for at least 8 weeks
1 Year
Overall Survival (OS)
時間枠：2 Year

OS defined as the time from the date the participant started study drug to death for any reason.
2 Year
Time to Response (TTR)
時間枠：1 Year

TTR is defined as the time from first dose to the first documented CR or PR which is subsequently confirmed.
1 Year
Number of Participants with Adverse Events
時間枠：2 Year

An adverse event (AE) is defined as any untoward medical occurrence in a patient and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.
2 Year
Maximum observed plasma concentration (Cmax) of NKT3964 under fed vs fasted conditions
時間枠：1 Month

Maximum observed plasma concentration (Cmax) of NKT3964
1 Month
Time to maximum observed plasma concentration of NKT3964 (Tmax) under fed vs fasted conditions
時間枠：1 Month

Time to maximum observed plasma concentration of NKT3964 (Tmax)
1 Month
Observed trough concentration of NKT3964 (Ctrough)
時間枠：88 Weeks

Observed trough concentration of NKT3964 (Ctrough)
88 Weeks
Area under the plasma concentration-time curve (AUC0-t) of NKT3964 under fed vs fasted conditions
時間枠：1 Month

Area under the plasma concentration-time curve (AUC0-t) of NKT3964
1 Month
Apparent clearance (CL/F) of NKT3964
時間枠：1 Month

Apparent clearance (CL/F)
1 Month
Apparent volume of distribution (V/F) of NKT3964
時間枠：1 Month

Apparent volume of distribution (V/F)
1 Month
Half-life (t1/2) of NKT3964
時間枠：1 Month

Half-life (t1/2)
1 Month
Accumulation ratio (AR) of NKT3964
時間枠：1 Month

Accumulation ratio (AR)
1 Month

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

NiKang Therapeutics, Inc.

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)

2024年9月19日

一次修了 (推定)

2029年1月1日

研究の完了 (推定)

2029年5月1日

試験登録日

最初に提出

2024年9月4日

QC基準を満たした最初の提出物

2024年9月4日

最初の投稿 (実際)

2024年9月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月5日

QC基準を満たした最後の更新が送信されました

2026年11月2日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • NKT3964-101

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

IPD are not planned to be shared at this time

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

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。

購読する