Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

En undersøgelse med NKT3964 for voksne med avancerede/metastatiske solide tumorer

28. oktober 2026 opdateret af: NiKang Therapeutics, Inc.

En fase 1, første-i-menneske, åben-label undersøgelse til evaluering af sikkerhed, tolerabilitet, PK og foreløbig antitumoraktivitet af den nye orale CDK2-degraderer NKT3964 hos voksne med avancerede/metastatiske solide tumorer

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.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

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

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
238

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: 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
Medicin: NKT3964

Oral CDK2 Degrader
Eksperimentel: 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
Medicin: NKT3964

Oral CDK2 Degrader

Medicin: 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.
Eksperimentel: 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
Medicin: NKT3964

Oral CDK2 Degrader

Medicin: 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.
Eksperimentel: 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
Medicin: NKT3964

Oral CDK2 Degrader
Eksperimentel: 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
Medicin: NKT3964

Oral CDK2 Degrader
Eksperimentel: 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
Medicin: NKT3964

Oral CDK2 Degrader
Eksperimentel: 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
Medicin: NKT3964

Oral CDK2 Degrader
Eksperimentel: 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.
Medicin: NKT3964

Oral CDK2 Degrader
Eksperimentel: 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.
Medicin: NKT3964

Oral CDK2 Degrader

Medicin: 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.
Eksperimentel: 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.
Medicin: NKT3964

Oral CDK2 Degrader

Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants with Dose Limiting Toxicity (DLT) events
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free survival (PFS)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 1 Year

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

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

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

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

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

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

Accumulation ratio (AR)
1 Month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
NiKang Therapeutics, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
19. september 2024

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. januar 2029

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. maj 2029

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
4. september 2024

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
4. september 2024

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
19. september 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
30. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
28. oktober 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • NKT3964-101

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

IPD are not planned to be shared at this time

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Cookieindstillinger

Vi bruger cookies for at sikre, at vi giver dig den bedste oplevelse på vores hjemmeside. For flere detaljer skal du læse omhyggeligt vores Politik om beskyttelse af personlige oplysninger og cookies. ...>>>Du kan når som helst ændre dine præferencer eller trække dit samtykke tilbage ved at slette cookies fra din hjemmeside eller computer som beskrevet i politikken. Accepter det og vælg dine præferencer ved at markere de tilsvarende felter i afsnittet "Administrer indstillinger" nedenfor. Læs vores servicevilkår omhyggeligt, inden du fortsætter med at bruge nogen del af dette websted.
«Administrer indstillinger