ClinicalTrials.gg
RecruitingNCT06586957Updated Nov 5, 2026

A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors

A Phase 1 interventional study of NKT3964 and Paclitaxel in Solid Tumor, Advanced Solid Tumor and Solid Tumor, Adult, sponsored by NiKang Therapeutics, Inc.. Recruiting at 21 sites in 2 countries. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by NiKang Therapeutics, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 1 month later.
Updated Nov 5, 2026First site in South KoreaSite recruiting status changed+4 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
238
Allocation
Non-randomized
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 2,053 studies in Neoplasm Metastasis with a site in United States — 347 open to participants now, 543 under way, 58 of them phase 3. Neoplasm Metastasis · United States.

Planned enrollment
266th of 1,862
238 · median 43
Started
2024
with 76 others
Phase 1
709 of 2,053
130 open now
Primary completion
2029-01
later than 452 of 541 live
Registered
1,885th of 2,053
by date

Among the 2,053 studies in Neoplasm Metastasis with a site in United States, this one is the 266th largest by planned enrollment of the 1,862 interventional ones that give a count, is one of 77 that started in 2024, is one of 709 in phase 1, reaches primary completion later than 452 of the 541 other live ones, and was the 1,885th registered.

Neoplasm Metastasis

4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.

Browse Neoplasm Metastasis studies →

Open to participants now

347 of the 2,053 studies in Neoplasm Metastasis with a site in United States are open now. Recruiting first, the newest first:

342 more — sign in →

All 347 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 688 Neoplasm Metastasis studies recruiting now, 536 (78%) set no upper age limit and 97 (14%) stop at 75 or younger; 48 take children under 18; 18 take healthy volunteers.

This study: 19 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 2,053 studies in Neoplasm Metastasis with a site in United States, or all of them as a file.
02

Study summary

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.

Read the detailed description

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
03

Conditions studied

  • Solid Tumor
  • Advanced Solid Tumor
  • Solid Tumor, Adult
  • Metastatic Tumor
  • Ovarian Cancer
  • Ovarian Neoplasms
  • Ovarian Carcinoma
  • Metastatic Ovarian Carcinoma
  • Endometrial Neoplasms
  • Endometrial Diseases
  • Metastatic Endometrial Cancer
  • Triple Negative Breast Cancer
  • Metastatic Endometrial Carcinoma
  • Advanced Endometrial Carcinoma
  • Advanced Ovarian Carcinoma
  • Gastric Cancer
  • Advanced Gastric Carcinoma
  • Metastatic Gastric Cancer
  • Metastatic Gastric Carcinoma
  • Small Cell Lung Cancer
  • Small Cell Lung Carcinoma
  • Triple Negative Breast Neoplasms
  • Platinum-resistant Ovarian Cancer
  • Platinum-refractory Ovarian Carcinoma
  • CCNE1 Amplification
  • Hormone Receptor Negative Breast Carcinoma
  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
  • Progesterone-receptor-positive Breast Cancer

Keywords

  • CDK 2 Inhibitor
  • CDK 4 Inhibitor
  • CDK 6 Inhibitor
  • CDK2 Degrader
  • Protein Degrader
  • PROTAC
04

Who can participate

The criteria were revised on the registry on Oct 6, 2026. See what changed

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- Must have a confirmed advanced and unresectable or 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 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; , 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 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 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, , or must be willing to use highly effective method(s) of
    • Ability to swallow oral medications.
    • Consent to provide archived tumor tissues and paired tumor at pretreatment

Exclusion criteria

Exclusion Criteria:

  • Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy.
  • History of another 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 )
  • cardiovascular event within 6 months prior to start of NKT3964 treatment
  • Known active 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 (HIV), active 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 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:
  • (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
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
238 participants (estimated)

Study arms

  • Experimental
    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

    Drug: NKT3964

  • Experimental
    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

    Drug: NKT3964 · Drug: Paclitaxel

  • Experimental
    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

    Drug: NKT3964 · Drug: Doxorubicin

  • Experimental
    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

    Drug: NKT3964

  • Experimental
    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

    Drug: NKT3964

  • Experimental
    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

    Drug: NKT3964

  • Experimental
    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

    Drug: NKT3964

  • Experimental
    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.

    Drug: NKT3964

  • Experimental
    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.

    Drug: NKT3964 · Drug: Paclitaxel

  • Experimental
    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.

    Drug: NKT3964 · Drug: Doxorubicin

Interventions

  • DrugNKT3964

    Oral CDK2 Degrader

  • 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.

  • 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.

06

What researchers measure

Primary outcomes

  1. Number of Participants with Dose Limiting Toxicity (DLT) events

    DLTs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

    Time frame: 28 Days

  2. Objective Response Rate (ORR)

    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

    Time frame: 1 Year

Secondary outcomes

  1. Progression-free survival (PFS)

    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.

    Time frame: 2 Year

  2. Duration of Response (DOR)

    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.

    Time frame: 2 Year

  3. Disease control rate

    Disease control rate defined as CR + PR + stable disease \[SD\] for at least 8 weeks

    Time frame: 1 Year

  4. Overall Survival (OS)

    OS defined as the time from the date the participant started study drug to death for any reason.

    Time frame: 2 Year

  5. Time to Response (TTR)

    TTR is defined as the time from first dose to the first documented CR or PR which is subsequently confirmed.

    Time frame: 1 Year

  6. Number of Participants with Adverse Events

    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.

    Time frame: 2 Year

  7. Maximum observed plasma concentration (Cmax) of NKT3964 under fed vs fasted conditions

    Maximum observed plasma concentration (Cmax) of NKT3964

    Time frame: 1 Month

  8. Time to maximum observed plasma concentration of NKT3964 (Tmax) under fed vs fasted conditions

    Time to maximum observed plasma concentration of NKT3964 (Tmax)

    Time frame: 1 Month

  9. Observed trough concentration of NKT3964 (Ctrough)

    Observed trough concentration of NKT3964 (Ctrough)

    Time frame: 88 Weeks

  10. Area under the plasma concentration-time curve (AUC0-t) of NKT3964 under fed vs fasted conditions

    Area under the plasma concentration-time curve (AUC0-t) of NKT3964

    Time frame: 1 Month

  11. Apparent clearance (CL/F) of NKT3964

    Apparent clearance (CL/F)

    Time frame: 1 Month

  12. Apparent volume of distribution (V/F) of NKT3964

    Apparent volume of distribution (V/F)

    Time frame: 1 Month

  13. Half-life (t1/2) of NKT3964

    Half-life (t1/2)

    Time frame: 1 Month

  14. Accumulation ratio (AR) of NKT3964

    Accumulation ratio (AR)

    Time frame: 1 Month

07

Study locations

17 of 21 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — IPD are not planned to be shared at this time

No publications or documents are linked to this record.

09

Timeline

6 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2024 (actual). Primary completion is estimated for Jan 2029, 52 months after the start.

Of 286 industry-sponsored phase 1 interventional studies under Neoplasm Metastasis, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 75. This study's planned 52 months is close to that.

Counting every sponsor, half of 496 studies reached it within 54 months; a quarter within 33 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2024
First posted
Sep 19, 2024
StartActual
Sep 19, 2024
Primary completionEst.
Jan 2029
CompletionEst.
May 2029
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites added — first site in South Korea. 2 sites changed recruiting status (2 now recruiting)
Show 2 sites
  • Augusta University · Augusta, United StatesNot yet recruiting→Recruiting
  • University of California - Los Angeles · Los Angeles, United StatesNot yet recruiting→Recruiting
Show 2 added (2 South Korea)
  • Yonsei Cancer Center / Severance Hospital · Seoul, South Korea
  • Chung-Ang University Gwangmyeong Hospital · Gwangmyeong, South Korea
across 3 updates, Oct 1, 2026 – Nov 5, 2026
Enrollment
150→238
Sep 28, 2026
Eligibility
Minimum age 18 Years→19 Years; Criteria revised in 2 updates
What changed on Sep 28, 2026
Inclusion criteria
  • Edited- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 onlyMonotherapy 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.
  • EditedPart 1 Monotherapy Dose Escalation:
  • EditedPart 2 Monotherapy Dose Expansion:
  • EditedPart 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 as determined by NGS by local liquid or tissue test.
  • EditedPart 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.
  • Added- Part 3 Combination Dose Escalation:
  • EditedPart 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
  • AddedPart 4 Combination Dose Expansion:
  • AddedAdvanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease with CCNE1 amplification. ο Subjects with clear cell carcinoma or uterine serous carcinoma histology may be considered regardless of CCNE1 status after discussion and approval from the Sponsor
Exclusion criteria
  • AddedPrior 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).
  • AddedFor subjects in Cohort 3B or 4B only:
  • AddedLeft ventricular ejection fraction (LVEF) <50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 4 weeks prior to first dose
  • AddedActive cardiac conditions including myocarditis, pericarditis, or clinically significant valvular heart disease
  • AddedKnown elevated cardiac biomarkers at baseline
  • AddedHistory of anthracycline-related cardiomyopathy regardless of recovery
  • AddedCumulative lifetime exposure to doxorubicin, including planned doxorubicin in Part 3b or Part 4b, exceeding 450 mg/m2
What changed on Oct 6, 2026
Inclusion criteria
  • EditedPart 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.
  • AddedPart 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.
  • Edited- Part 3 Combination Dose Escalation:
  • EditedAdvanced 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)
  • Edited-Part 4 Combination Dose Expansion:
  • EditedAdvanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease with CCNE1 amplification. ο (Subjects with clear cell carcinoma or uterine serous carcinoma histology may be considered regardless of CCNE1 status after discussion and approval from the Sponsor)
across 2 updates, Sep 28, 2026 – Oct 6, 2026
Interventions
Added Drug: Paclitaxel·Drug: Doxorubicin. Arm changed Dose Escalation→Monotherapy Dose Escalation; Dose Expansion→Monotherapy Dose Expansion 2A. Arms added: Combination Dose Expansion 4A·Combination Dose Expansion 4B·Monotherapy Dose Expansion 2B·Monotherapy Dose Expansion 2C·Monotherapy Dose Expansion 2D·and 3 more
All 8

Combination Dose Expansion 4A · Combination Dose Expansion 4B · Monotherapy Dose Expansion 2B · Monotherapy Dose Expansion 2C · Monotherapy Dose Expansion 2D · Monotherapy Dose Expansion 2E · Combination Dose Escalation 3A · Combination Dose Escalation 3B

Sep 28, 2026
Secondary outcomes
3 edited
What changed in the outcomes
  • EditedTime to maximum observed plasma concentration of NKT3964 (Tmax) with and without a high-fat and/or low-fat mealunder fed vs fasted conditionsTime frame: 1 Month
  • EditedArea under the plasma concentration-time curve (AUC0-t) of NKT3964 with and without a high-fat and/or low-fat mealunder fed vs fasted conditionsTime frame: 1 Month
  • ChangedBefore Maximum observed plasma concentration (Cmax) of NKT3964 with and without a high-fat and/or low-fat mealNow Maximum observed plasma concentration (Cmax) of NKT3964 under fed vs fasted conditionsTime frame: 1 Month
Sep 28, 2026
Site contacts
Changed at 5 sites. See the sites
Show 5 sites
  • Augusta University · Augusta, United StatesContact person changed (no phone or email listed)
  • University of California - Los Angeles · Los Angeles, United StatesContact added S•••@mednet.ucla.edu · •••8933
  • AdventHealth Cancer Institute · Orlando, United StatesContact person changed (no phone or email listed)
  • Emory Winship Cancer Institute · Atlanta, United StatesContact person changed (no phone or email listed)
  • Yonsei Cancer Center / Severance Hospital · Seoul, South KoreaContact •••0430→•••0430
across 4 updates, Sep 28, 2026 – Nov 5, 2026
Show all 6 updates
  1. Nov 5, 2026
    1 site added
    Show site
    • Chung-Ang University Gwangmyeong Hospital · Gwangmyeong, South Korea
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Yonsei Cancer Center / Severance Hospital · Seoul, South KoreaContact •••0430→•••0430
    + 1 other change: verification date
  2. Oct 30, 2026
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Emory Winship Cancer Institute · Atlanta, United StatesContact person changed (no phone or email listed)
  3. Oct 16, 2026
    1 site added — first site in South Korea. University of California - Los Angeles is now Recruiting
    Show site
    • Yonsei Cancer Center / Severance Hospital · Seoul, South Korea
    Site contacts Changed at 2 sites. See the sites
    Show 2 sites
    • University of California - Los Angeles · Los Angeles, United StatesContact added S•••@mednet.ucla.edu · •••8933
    • AdventHealth Cancer Institute · Orlando, United StatesContact person changed (no phone or email listed)
  4. Oct 6, 2026
    Eligibility 5 inclusion criteria edited, 1 added
    What changed in the criteria
    Inclusion criteria
    • EditedPart 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.
    • AddedPart 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.
    • Edited- Part 3 Combination Dose Escalation:
    • EditedAdvanced 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)
    • Edited-Part 4 Combination Dose Expansion:
    • EditedAdvanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease with CCNE1 amplification. ο (Subjects with clear cell carcinoma or uterine serous carcinoma histology may be considered regardless of CCNE1 status after discussion and approval from the Sponsor)
    + 1 other change: verification date
  5. Oct 1, 2026
    Augusta University is now Recruiting
  6. Sep 28, 2026
    Enrollment 150→238
    Eligibility Minimum age 18 Years→19 Years; 6 inclusion criteria edited, 3 added; 7 exclusion criteria added
    What changed in the criteria
    Inclusion criteria
    • Edited- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 onlyMonotherapy 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.
    • EditedPart 1 Monotherapy Dose Escalation:
    • EditedPart 2 Monotherapy Dose Expansion:
    • EditedPart 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 as determined by NGS by local liquid or tissue test.
    • EditedPart 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.
    • Added- Part 3 Combination Dose Escalation:
    • EditedPart 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
    • AddedPart 4 Combination Dose Expansion:
    • AddedAdvanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease with CCNE1 amplification. ο Subjects with clear cell carcinoma or uterine serous carcinoma histology may be considered regardless of CCNE1 status after discussion and approval from the Sponsor
    Exclusion criteria
    • AddedPrior 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).
    • AddedFor subjects in Cohort 3B or 4B only:
    • AddedLeft ventricular ejection fraction (LVEF) <50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 4 weeks prior to first dose
    • AddedActive cardiac conditions including myocarditis, pericarditis, or clinically significant valvular heart disease
    • AddedKnown elevated cardiac biomarkers at baseline
    • AddedHistory of anthracycline-related cardiomyopathy regardless of recovery
    • AddedCumulative lifetime exposure to doxorubicin, including planned doxorubicin in Part 3b or Part 4b, exceeding 450 mg/m2
    Secondary outcomes 3 edited
    What changed in the outcomes
    • EditedTime to maximum observed plasma concentration of NKT3964 (Tmax) with and without a high-fat and/or low-fat mealunder fed vs fasted conditionsTime frame: 1 Month
    • EditedArea under the plasma concentration-time curve (AUC0-t) of NKT3964 with and without a high-fat and/or low-fat mealunder fed vs fasted conditionsTime frame: 1 Month
    • ChangedBefore Maximum observed plasma concentration (Cmax) of NKT3964 with and without a high-fat and/or low-fat mealNow Maximum observed plasma concentration (Cmax) of NKT3964 under fed vs fasted conditionsTime frame: 1 Month
    Interventions Added Drug: Paclitaxel·Drug: Doxorubicin. Arm changed Dose Escalation→Monotherapy Dose Escalation; Dose Expansion→Monotherapy Dose Expansion 2A. Arms added: Combination Dose Expansion 4A·Combination Dose Expansion 4B·Monotherapy Dose Expansion 2B·Monotherapy Dose Expansion 2C·Monotherapy Dose Expansion 2D·and 3 more
    All 8

    Combination Dose Expansion 4A · Combination Dose Expansion 4B · Monotherapy Dose Expansion 2B · Monotherapy Dose Expansion 2C · Monotherapy Dose Expansion 2D · Monotherapy Dose Expansion 2E · Combination Dose Escalation 3A · Combination Dose Escalation 3B

    Site contacts Changed at 1 site. See the sites
    Show the site
    • Augusta University · Augusta, United StatesContact person changed (no phone or email listed)
    + 4 other changes: verification date, description, design details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06586957
Lead sponsor
NiKang Therapeutics, Inc.
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Sep 19, 2024
Primary completion
Jan 2029 (estimated)
Completion
May 2029 (estimated)
Last update
Nov 5, 2026

Study contacts

Sponsor Contact
Contact
clinicaltrials@nikangtx.com
(302) 596-8654

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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