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New treatment option 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 medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
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 goal of the Dose Escalation phase 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 Expansion phase of the study 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).
- 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 18 and older
You may be able to join if
- \- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last...
- 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)
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
- \- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 only: people must be refractory to, or...
- 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 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- Lake Mary, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Fairway, Kansas, United States
- Boston, Massachusetts, United States
- Hackensack, New Jersey, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, 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
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 - 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Los Angeles, California, United States; San Francisco, California, United States; Denver, Colorado, United States; Lake Mary, Florida, United States; Orlando, Florida, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.