Solid TumorPhase 1NCT06264921
A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors
A Phase 1 study testing NKT3447 in people with Solid Tumor and Solid Tumor, Adult, run by NiKang Therapeutics, Inc. at 8 sites in United States.
Trial summary
The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Solid Tumor, Adult, Advanced Solid Tumor
- What is being tested?
- NKT3447
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 8 sitesUnited States
- Study dates
- 23 Feb 2024to 16 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have confirmed unresectable advanced/metastatic solid tumors (as outlined below) with disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment likely to improve the disease outcome in the judgment of the Investigator.
- Measurable disease per the RECIST v1.1
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Able to swallow oral medications.
- Dose Escalation(Part 1):
- Ovarian cancer
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- Endometrial cancer
- Gastric cancer or gastroesophageal junction cancer
- Small cell lung cancer (SCLC)
- Triple-negative breast cancer (human epidermal growth factor receptor 2 [HER2], estrogen receptor [ER], progesterone receptor negative)
- ER/progesterone-receptor positive, HER2 negative breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and not suitable for endocrine therapy)
- Other solid tumors with CCNE1 amplification as determined by NGS by local liquid or tissue biopsy.
- Dose Expansion (Part 2):
- Platinum resistant or refractory ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least 1 platinum containing therapy with CCNE1 amplification as determined by NGS by local liquid or tissue biopsy.
- Measurable disease per the RECIST v1.1
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Able to swallow oral medications.
Who cannot join
- 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
- Visceral crisis with life-threatening complications, lymphangitic spread, CNS metastasis and/or carcinomatous meningitis
- Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)
- Clinically active interstitial lung disease
- History of uveitis, retinopathy or other clinically significant retinal disease
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- Has known human immunodeficiency virus (HIV), active hepatitis B or C infection
- Prior CDK2 inhibitor
- Major surgery within 2 months or minor surgery within 10 days before the first dose of NKT3447
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Augusta University Georgia Cancer Center
Augusta, Georgia, 30909
Texas Oncology-Austin Midtown NEXT Oncology
Austin, Texas, 78758
The Gabrail Pharmacology Phase 1 Research Center
Canton, Ohio, 44718
AdventHealth Cancer Institute
Celebration, Florida, 34747
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Norton Cancer Institute - Broadway
Louisville, Kentucky, 40202
University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
START Mountain Region
West Valley City, Utah, 84119
About this study
Official title: A Phase 1, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Orally Available CDK2 Inhibitor NKT3447 in Adults With Advanced/Metastatic Solid Tumors
The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and the preliminary antitumor activity of NKT3447 in adult subjects with cyclin E1 (CCNE1) amplified ovarian cancer at the RDEs selected in Dose Escalation and to determine the preliminary recommended phase 2 dose (RP2D).
Read the detailed description
This is a Phase 1/1b, first-in-human, open-label, multicenter study of NKT3447 in adults with advanced/ metastatic solid tumors. The study consists of 2 parts, a Dose Escalation phase and a Dose Expansion phase. Eligible patients must have confirmed advanced/metastatic solid tumors (as outlined below) with disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment likely to improve the disease outcome in the judgment of the investigator.
Dose Escalation:
- Ovarian cancer
- Endometrial cancer
- Gastric cancer or gastroesophageal junction cancer
- Small cell lung cancer
- Triple-negative breast cancer (human epidermal growth factor receptor 2, estrogen receptor, progesterone receptor negative)
- Estrogen receptor/progesterone-receptor positive (ER+/PR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and not suitable for endocrine therapy)
- Other solid tumors with CCNE1 amplification as determined by next generation sequencing by local liquid or tissue biopsy.
Dose Expansion:
- Platinum resistant or refractory ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least 1 platinum containing therapy with cyclin E amplification as determined by fluorescence in situ hybridization, quantitative polymerase chain reaction, or next-generation sequencing by local liquid or tissue biopsy.
The Dose Escalation phase will evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors.
The Dose Expansion phase will evaluate the safety, tolerability, pharmacokinetics (PK), and the preliminary antitumor activity of NKT3447 in adult subjects with CCNE1 amplified ovarian cancer at the RDEs selected in Dose Escalation and to determine the preliminary recommended RP2D.
- Conditions
- Solid Tumor, Solid Tumor, Adult, Advanced Solid Tumor, Metastatic Tumor, Ovarian Cancer, Ovarian Neoplasms
- Being tested
- NKT3447
- Keywords
- CDK 2 Inhibitor, CDK 4 Inhibitor, CDK 6 Inhibitor
- Medical subject headings
- Neoplasm Metastasis, Ovarian Neoplasms, Endometrial Neoplasms, Uterine Diseases, Stomach Neoplasms, Small Cell Lung Carcinoma, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKT3447Drug
Oral CDK2 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Dose escalation will assess the safety, efficacy, and PK/PD data of oral dosing NKT3447 at increasing dosage levels to determine the MTD and/or preliminary RDEs. Receives: Drug: NKT3447 |
| Dose Expansion | Experimental | Dose expansion will include 2 RDEs selected to determine the preliminary antitumor activity and the RP2D. Receives: Drug: NKT3447 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
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
Measured: 1 year
Secondary outcomes (14)
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.
Measured: 2 years
Duration of Response (DOR)
Duration of overall response is defined as the time from the date of first documented CR or PR, assessed by investigator and based on RECIST v. 1.1, to the documented date of progressive disease (PD) or death, whichever occurred first.
Measured: 2 years
Disease control rate
Disease control rate defined as CR + PR + stable disease [SD]
Measured: 1 year
Overall Survival (OS)
OS defined as the time from the date the participant started study drug to death for any reason.
Measured: 2 years
Time to Response (TTR)
TTR is defined as the time from first dose to the first documented CR or PR which is subsequently confirmed.
Measured: 1 year
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.
Measured: 2 years
Maximum observed plasma concentration (Cmax) of NKT3447
Maximum observed plasma concentration (Cmax) of NKT3447
Measured: 1 month
Time to maximum observed plasma concentration of NKT3447 (Tmax)
Time to maximum observed plasma concentration of NKT3447 (Tmax)
Measured: 1 month
Observed trough concentration of NKT3447 (Ctrough)
Observed trough concentration of NKT3447 (Ctrough)
Measured: 88 weeks
Area under the plasma concentration-time curve (AUC0-t) of NKT3447
Area under the plasma concentration-time curve (AUC0-t) of NKT3447
Measured: 1 month
Apparent clearance (CL/F)
Apparent clearance (CL/F)
Measured: 1 month
Apparent volume of distribution (V/F)
Apparent volume of distribution (V/F)
Measured: 1 month
Half-life (t1/2)
Half-life (t1/2)
Measured: 1 month
Accumulation ratio (AR)
Accumulation ratio (AR)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start23 Feb 2024
- Primary completion7 Apr 2025
- Study completion16 Apr 2025
Why it stopped: This study was terminated as a result of Sponsor portfolio reprioritization.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose Escalation and Dose Expansion
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- NiKang Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264921
- Sponsor's protocol ID
- NKT3447-101
- Status last verified
- Sep 2025
- First submitted
- 9 Feb 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are not planned to be shared at this time
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Orally Available CDK2 Inhibitor NKT3447 in Adults With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06264921
- Acronym / sponsor ID
- NKT3447-101
- Conditions
- Solid Tumor, Solid Tumor, Adult, Advanced Solid Tumor, Metastatic Tumor, Ovarian Cancer, Ovarian Neoplasms
- Keywords
- CDK 2 Inhibitor, CDK 4 Inhibitor, CDK 6 Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated as a result of Sponsor portfolio reprioritization.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- NiKang Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 16 Apr 2025 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and the preliminary antitumor activity of NKT3447 in adult subjects with cyclin E1 (CCNE1) amplified ovarian cancer at the RDEs selected in Dose Escalation and to determine the preliminary recommended phase 2 dose (RP2D).
Detailed description
This is a Phase 1/1b, first-in-human, open-label, multicenter study of NKT3447 in adults with advanced/ metastatic solid tumors. The study consists of 2 parts, a Dose Escalation phase and a Dose Expansion phase. Eligible patients must have confirmed advanced/metastatic solid tumors (as outlined below) with disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment likely to improve the disease outcome in the judgment of the investigator.
Dose Escalation:
- Ovarian cancer
- Endometrial cancer
- Gastric cancer or gastroesophageal junction cancer
- Small cell lung cancer
- Triple-negative breast cancer (human epidermal growth factor receptor 2, estrogen receptor, progesterone receptor negative)
- Estrogen receptor/progesterone-receptor positive (ER+/PR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and not suitable for endocrine therapy)
- Other solid tumors with CCNE1 amplification as determined by next generation sequencing by local liquid or tissue biopsy.
Dose Expansion:
- Platinum resistant or refractory ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least 1 platinum containing therapy with cyclin E amplification as determined by fluorescence in situ hybridization, quantitative polymerase chain reaction, or next-generation sequencing by local liquid or tissue biopsy.
The Dose Escalation phase will evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors.
The Dose Expansion phase will evaluate the safety, tolerability, pharmacokinetics (PK), and the preliminary antitumor activity of NKT3447 in adult subjects with CCNE1 amplified ovarian cancer at the RDEs selected in Dose Escalation and to determine the preliminary recommended RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dose Escalation and Dose Expansion
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: NKT3447Dose escalation will assess the safety, efficacy, and PK/PD data of oral dosing NKT3447 at increasing dosage levels to determine the MTD and/or preliminary RDEs. |
| Dose Expansion | Experimental | Drug: NKT3447Dose expansion will include 2 RDEs selected to determine the preliminary antitumor activity and the RP2D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Must have confirmed unresectable advanced/metastatic solid tumors (as outlined below) with disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment likely to improve the disease outcome in the judgment of the Investigator.
- Ovarian cancer
- Endometrial cancer
- Gastric cancer or gastroesophageal junction cancer
- Small cell lung cancer (SCLC)
Key exclusion criteria (9 listed)
- 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
- Visceral crisis with life-threatening complications, lymphangitic spread, CNS metastasis and/or carcinomatous meningitis
- Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)
- Clinically active interstitial lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NKT3447Oral CDK2 inhibitor | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Number of Participants with Dose Limiting Toxicity (DLT) events
Time frame: 28 days
DLTs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 .0.
Objective Response Rate (ORR)
Time frame: 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
14 secondary outcomes
Progression-free survival (PFS)
Time frame: 2 years
Duration of Response (DOR)
Time frame: 2 years
Disease control rate
Time frame: 1 year
Overall Survival (OS)
Time frame: 2 years
Time to Response (TTR)
Time frame: 1 year
Number of Participants with Adverse Events
Time frame: 2 years
Maximum observed plasma concentration (Cmax) of NKT3447
Time frame: 1 month
Time to maximum observed plasma concentration of NKT3447 (Tmax)
Time frame: 1 month
Observed trough concentration of NKT3447 (Ctrough)
Time frame: 88 weeks
Area under the plasma concentration-time curve (AUC0-t) of NKT3447
Time frame: 1 month
Apparent clearance (CL/F)
Time frame: 1 month
Apparent volume of distribution (V/F)
Time frame: 1 month
Half-life (t1/2)
Time frame: 1 month
Accumulation ratio (AR)
Time frame: 1 month
Results and safety
The study was stopped early (reason given: This study was terminated as a result of Sponsor portfolio reprioritization.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No. IPD are not planned to be shared at this time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NKT3447 in people with Solid Tumor and Solid Tumor, Adult, run by NiKang Therapeutics, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study was terminated as a result of Sponsor portfolio reprioritization.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose Limiting Toxicity (DLT) events (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.