이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

진행성/전이성 고형 종양이 있는 성인을 대상으로 한 NKT3964 연구

2026년 11월 2일 업데이트: NiKang Therapeutics, Inc.

진행성/전이성 고형 종양이 있는 성인을 대상으로 새로운 경구용 CDK2 분해제 NKT3964의 안전성, 내약성, PK 및 예비 항종양 활성을 평가하기 위한 1상 인간 최초 공개 라벨 연구

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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

연구 유형

중재적

등록 (추정된)

238

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 대한민국
      • Seoul, 대한민국, 03722
        • 모병
        • Yonsei Cancer Center / Severance Hospital
        • 수석 연구원:
          • Jung-Yun Lee, MD
        • 연락하다:
          • Severance Hospital IRB
          • 전화번호: +82-02-2228-0430
          • 이메일: irb@yuhs.ac
    • Gyeonggi-do
      • Gwangmyeong, Gyeonggi-do, 대한민국, 14353
        • 모병
        • Chung-Ang University Gwangmyeong Hospital
        • 수석 연구원:
          • Byoung-Gie Kim, MD
        • 연락하다:
  • 미국
    • Arkansas
      • Little Rock, Arkansas, 미국, 72205
        • 모병
        • University of Arkansas Medical School
        • 수석 연구원:
          • Michael Birrer, MD
        • 연락하다:
    • California
      • Los Angeles, California, 미국, 90095
        • 모병
        • University of California - Los Angeles
        • 수석 연구원:
          • Gottfried Konecny, MD
        • 연락하다:
      • San Francisco, California, 미국, 94158
        • 빼는
        • UCSF
    • Colorado
      • Denver, Colorado, 미국, 80218
    • Florida
      • Lake Mary, Florida, 미국, 32746
        • 종료됨
        • Florida Cancer Specialists & Research Institute
      • Orlando, Florida, 미국, 32804
        • 모병
        • AdventHealth Cancer Institute
        • 수석 연구원:
          • Robert Holloway, MD
        • 연락하다:
    • Georgia
      • Atlanta, Georgia, 미국, 30322
        • 모병
        • Emory Winship Cancer Institute
        • 수석 연구원:
          • Beryl Manning-Geist, MD
        • 연락하다:
      • Augusta, Georgia, 미국, 30912
        • 모병
        • Augusta University
        • 수석 연구원:
          • Bunja Rungruang, MD
    • Kansas
      • Fairway, Kansas, 미국, 66205
        • 빼는
        • University of Kansas
    • Massachusetts
      • Boston, Massachusetts, 미국, 02215
        • 모병
        • Dana Farber Cancer Institute
        • 연락하다:
        • 수석 연구원:
          • Elizabeth LEE, MD
    • New Jersey
      • Hackensack, New Jersey, 미국, 07601
        • 모병
        • John Theurer Cancer Center at Hackensack UMC
        • 수석 연구원:
          • Martin Gutierrez, MD
        • 연락하다:
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19107
        • 모병
        • Sidney Kimmell Cancer Center - Jefferson Health
        • 연락하다:
          • Sarah Cannon Research Institute
          • 전화번호: 844-482-4812
        • 수석 연구원:
          • Ida Micaily, MD
      • Pittsburgh, Pennsylvania, 미국, 15213
        • 빼는
        • UPMC
    • Tennessee
      • Nashville, Tennessee, 미국, 37203
        • 모병
        • Sarah Cannon Research Institute (SCRI)
        • 수석 연구원:
          • Denise Yardley, MD
        • 연락하다:
    • Texas
      • Austin, Texas, 미국, 78758
        • 모병
        • NEXT Oncology
        • 연락하다:
        • 수석 연구원:
          • Sheena Sahota, MD
      • Dallas, Texas, 미국, 75235
    • Utah
      • Salt Lake City, Utah, 미국, 84145
        • 모병
        • Intermountain Health
        • 연락하다:
        • 수석 연구원:
          • Caroline Nebhan, MD
    • Virginia
      • Charlottesville, Virginia, 미국, 22903
        • 모병
        • University of Virginia
        • 수석 연구원:
          • Linda Duska, MD
        • 연락하다:
      • Fairfax, Virginia, 미국, 22031
        • 모병
        • NEXT Virginia
        • 수석 연구원:
          • Alexander Spira, MD
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

19년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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
의약품: NKT3964

Oral CDK2 Degrader
실험적: 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
의약품: NKT3964

Oral CDK2 Degrader

의약품: 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.
실험적: 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
의약품: NKT3964

Oral CDK2 Degrader

의약품: 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.
실험적: 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
의약품: NKT3964

Oral CDK2 Degrader
실험적: 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
의약품: NKT3964

Oral CDK2 Degrader
실험적: 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
의약품: NKT3964

Oral CDK2 Degrader
실험적: 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
의약품: NKT3964

Oral CDK2 Degrader
실험적: 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.
의약품: NKT3964

Oral CDK2 Degrader
실험적: 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.
의약품: NKT3964

Oral CDK2 Degrader

의약품: 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.
실험적: 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.
의약품: NKT3964

Oral CDK2 Degrader

의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants with Dose Limiting Toxicity (DLT) events
기간: 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)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Progression-free survival (PFS)
기간: 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)
기간: 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
기간: 1 Year

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

Time to maximum observed plasma concentration of NKT3964 (Tmax)
1 Month
Observed trough concentration of NKT3964 (Ctrough)
기간: 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
기간: 1 Month

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

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

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

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

Accumulation ratio (AR)
1 Month

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

NiKang Therapeutics, Inc.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 9월 19일

기본 완료 (추정된)

2029년 1월 1일

연구 완료 (추정된)

2029년 5월 1일

연구 등록 날짜

최초 제출

2024년 9월 4일

QC 기준을 충족하는 최초 제출

2024년 9월 4일

처음 게시됨 (실제)

2024년 9월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NKT3964-101

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

IPD are not planned to be shared at this time

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다