Actively Recruiting
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Led by NiKang Therapeutics, Inc. · Updated on 2026-04-21
150
Participants Needed
19
Research Sites
240 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have a pathologically confirmed advanced, unresectable, or metastatic solid tumor with disease progression on last standard treatment
- For Dose Escalation: must be refractory or intolerant to existing beneficial therapies
- Diagnosed with one of the following: ovarian cancer, endometrial cancer (endometrioid subtype requires CCNE1 amplification), gastric/GEJ/esophageal adenocarcinoma with CCNE1 amplification, small cell lung cancer, triple-negative breast cancer, HR+ and HER2- breast cancer progressed after CDK4/6 inhibitor treatment and unsuitable for endocrine therapy, or other solid tumors with CCNE1 amplification
- For Dose Expansion: specific subgroups of breast, ovarian, gastric, endometrial, or uterine cancers with prior treatments as detailed
- Have measurable or evaluable disease according to RECIST v1.1
- Age 18 years or older
- ECOG performance status 0-1
- Adequate organ function
- Females with reproductive organs must be surgically sterile, post-menopausal, or use effective contraception
- Ability to swallow oral medications
- Consent to provide archived tumor tissues and paired tumor biopsies
You will not qualify if you...
- Locally advanced solid tumors that can be cured with surgery, radiotherapy, or chemotherapy
- History of other malignancies except certain exceptions
- History of lymphohistiocytic or lymphoid hyperplasia or hemophagocytic lymphohistiocytosis
- Not recovered to baseline or Grade 1 severity from prior anticancer therapy effects
- Cardiovascular events within 6 months before starting NKT3964
- Known active CNS metastases or carcinomatous meningitis
- Active interstitial lung disease requiring treatment
- History of uveitis, retinopathy, or significant retinal disease
- Active or chronic corneal or ocular conditions requiring ongoing treatment
- Recent major surgery within 1 month or minor surgery within 10 days before first dose
- Known HIV, active hepatitis B or C infection
- Prior treatment with selective or nonselective CDK2 inhibitors or degraders
- Child-Pugh class B or C cirrhosis or significant liver disorders
- Palliative radiation within 14 days or other radiation within 4 weeks prior to first treatment day
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
University of Arkansas Medical School
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
University of California - Los Angeles
Los Angeles, California, United States, 90095
Not Yet Recruiting
3
UCSF
San Francisco, California, United States, 94158
Withdrawn
4
SCRI at HealthOne
Denver, Colorado, United States, 80218
Actively Recruiting
5
Florida Cancer Specialists & Research Institute
Lake Mary, Florida, United States, 32746
Terminated
6
AdventHealth Cancer Institute
Orlando, Florida, United States, 32804
Actively Recruiting
7
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
Augusta University
Augusta, Georgia, United States, 30912
Not Yet Recruiting
9
University of Kansas
Fairway, Kansas, United States, 66205
Withdrawn
10
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
11
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States, 07601
Actively Recruiting
12
Sidney Kimmell Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
13
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Withdrawn
14
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, United States, 37203
Actively Recruiting
15
NEXT Oncology
Austin, Texas, United States, 78758
Actively Recruiting
16
UT Southwestern
Dallas, Texas, United States, 75235
Actively Recruiting
17
Intermountain Health
Salt Lake City, Utah, United States, 84145
Actively Recruiting
18
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
19
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
S
Sponsor Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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