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Uno studio con NKT3964 per adulti con tumori solidi avanzati/metastatici

28 ottobre 2026 aggiornato da: NiKang Therapeutics, Inc.

Uno studio di Fase 1, il primo sull’uomo, in aperto, per valutare la sicurezza, la tollerabilità, la farmacocinetica e l’attività antitumorale preliminare del nuovo degradatore orale di CDK2 NKT3964 negli adulti con tumori solidi avanzati/metastatici

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Interventistico

Iscrizione (Stimato)

238

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Corea del Sud
      • Seoul, Corea del Sud, 03722
        • Reclutamento
        • Yonsei Cancer Center / Severance Hospital
        • Contatto:
          • Severance Hospital IRB
          • Numero di telefono: 02-2228-0430
          • Email: irb@yuhs.ac
        • Investigatore principale:
          • Jung-Yun Lee, MD
  • Stati Uniti
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti, 72205
        • Reclutamento
        • University of Arkansas Medical School
        • Investigatore principale:
          • Michael Birrer, MD
        • Contatto:
    • California
      • Los Angeles, California, Stati Uniti, 90095
        • Reclutamento
        • University of California - Los Angeles
        • Investigatore principale:
          • Gottfried Konecny, MD
        • Contatto:
      • San Francisco, California, Stati Uniti, 94158
        • Ritirato
        • UCSF
    • Colorado
      • Denver, Colorado, Stati Uniti, 80218
    • Florida
      • Lake Mary, Florida, Stati Uniti, 32746
        • Terminato
        • Florida Cancer Specialists & Research Institute
      • Orlando, Florida, Stati Uniti, 32804
        • Reclutamento
        • AdventHealth Cancer Institute
        • Investigatore principale:
          • Robert Holloway, MD
        • Contatto:
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
        • Reclutamento
        • Emory Winship Cancer Institute
        • Investigatore principale:
          • Beryl Manning-Geist, MD
        • Contatto:
      • Augusta, Georgia, Stati Uniti, 30912
        • Reclutamento
        • Augusta University
        • Investigatore principale:
          • Bunja Rungruang, MD
    • Kansas
      • Fairway, Kansas, Stati Uniti, 66205
        • Ritirato
        • University of Kansas
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
        • Reclutamento
        • Dana Farber Cancer Institute
        • Contatto:
        • Investigatore principale:
          • Elizabeth LEE, MD
    • New Jersey
      • Hackensack, New Jersey, Stati Uniti, 07601
        • Reclutamento
        • John Theurer Cancer Center at Hackensack UMC
        • Investigatore principale:
          • Martin Gutierrez, MD
        • Contatto:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19107
        • Reclutamento
        • Sidney Kimmell Cancer Center - Jefferson Health
        • Contatto:
          • Sarah Cannon Research Institute
          • Numero di telefono: 844-482-4812
        • Investigatore principale:
          • Ida Micaily, MD
      • Pittsburgh, Pennsylvania, Stati Uniti, 15213
        • Ritirato
        • UPMC
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37203
        • Reclutamento
        • Sarah Cannon Research Institute (SCRI)
        • Investigatore principale:
          • Denise Yardley, MD
        • Contatto:
    • Texas
      • Austin, Texas, Stati Uniti, 78758
        • Reclutamento
        • NEXT Oncology
        • Contatto:
        • Investigatore principale:
          • Sheena Sahota, MD
      • Dallas, Texas, Stati Uniti, 75235
        • Reclutamento
        • UT Southwestern
        • Investigatore principale:
          • David Miller, MD
        • Contatto:
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84145
        • Reclutamento
        • Intermountain Health
        • Contatto:
        • Investigatore principale:
          • Caroline Nebhan, MD
    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22903
        • Reclutamento
        • University of Virginia
        • Investigatore principale:
          • Linda Duska, MD
        • Contatto:
      • Fairfax, Virginia, Stati Uniti, 22031
        • Reclutamento
        • NEXT Virginia
        • Investigatore principale:
          • Alexander Spira, MD
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

19 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Droga: NKT3964

Oral CDK2 Degrader
Sperimentale: 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
Droga: NKT3964

Oral CDK2 Degrader

Droga: 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.
Sperimentale: 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
Droga: NKT3964

Oral CDK2 Degrader

Droga: 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.
Sperimentale: 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
Droga: NKT3964

Oral CDK2 Degrader
Sperimentale: 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
Droga: NKT3964

Oral CDK2 Degrader
Sperimentale: 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
Droga: NKT3964

Oral CDK2 Degrader
Sperimentale: 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
Droga: NKT3964

Oral CDK2 Degrader
Sperimentale: 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.
Droga: NKT3964

Oral CDK2 Degrader
Sperimentale: 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.
Droga: NKT3964

Oral CDK2 Degrader

Droga: 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.
Sperimentale: 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.
Droga: NKT3964

Oral CDK2 Degrader

Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants with Dose Limiting Toxicity (DLT) events
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free survival (PFS)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 1 Year

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

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

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

Apparent clearance (CL/F)
1 Month
Apparent volume of distribution (V/F) of NKT3964
Lasso di tempo: 1 Month

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

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

Accumulation ratio (AR)
1 Month

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

NiKang Therapeutics, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 settembre 2024

Completamento primario (Stimato)

1 gennaio 2029

Completamento dello studio (Stimato)

1 maggio 2029

Date di iscrizione allo studio

Primo inviato

4 settembre 2024

Primo inviato che soddisfa i criteri di controllo qualità

4 settembre 2024

Primo Inserito (Effettivo)

19 settembre 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NKT3964-101

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

IPD are not planned to be shared at this time

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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