Clinical trial for Solid Tumor
Official title A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06586957
What this study is testing
What is NKT3964?
NKT3964 is an investigational oral medicine being studied for the treatment of advanced or metastatic solid tumors.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study looks at how safe and well the drug is, how it moves through the body, and whether it shows early signs of shrinking tumors. It also checks if the drug works well with chemotherapy for endometrial cancer.
- Who it's for
- Adults who have advanced or metastatic solid tumors, including ovarian, endometrial, breast, gastric, or lung cancers, and who have tried other treatments.
- What's involved
- Participants receive the drug alone or with chemotherapy, have regular blood tests, scans, and clinic visits to monitor safety and tumor response.
- Time commitment
- The study lasts several months, with frequent visits for dosing, blood draws, and imaging to track safety and tumor changes.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Ovarian cancer
- Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)
- Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification
- Small cell lung cancer (SCLC)
- Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)
You likely can't join if
- 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
See the full eligibility criteria
- Ovarian cancer
- Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)
- Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification
- Small cell lung cancer (SCLC)
- Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)
- 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])
- Other solid tumors with CCNE1 amplification
- Part 2A: HR+ and HER2- breast cancer that is locally advanced and unresectable (Stage III) or metastatic (Stage IV)
- 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...
- 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...
- 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.
- Part 2E: Advanced/recurrent uterine carcinosarcoma previously treated with 1 prior platinum-based chemotherapy regimen and ≤3 prior lines of systemic therapy.
- 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.
- 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.
- Have adequate organ function
- people 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Denver, Colorado, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Boston, Massachusetts, United States
- Hackensack, New Jersey, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Salt Lake City, Utah, United States
- Charlottesville, Virginia, United States
- Fairfax, Virginia, United States
- Gwangmyeong, Gyeonggi-do, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Little Rock, Arkansas, United States; Los Angeles, California, United States; Denver, Colorado, United States; Orlando, Florida, United States; Atlanta, Georgia, United States; Augusta, Georgia, United States and 11 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.