A Phase 1 interventional study of NKT3447 in Solid Tumor, Solid Tumor, Adult and Advanced Solid Tumor, sponsored by NiKang Therapeutics, Inc.. Terminated at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by NiKang Therapeutics, Inc. · Phase 1, Interventional, and Treatment
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).
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:
Dose Expansion:
a. 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.
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.
Dose Escalation(Part 1):
Dose Expansion (Part 2):
a. 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.
Exclusion Criteria:
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.
Drug: NKT3447
Dose expansion will include 2 RDEs selected to determine the preliminary antitumor activity and the RP2D.
Drug: NKT3447
Oral CDK2 inhibitor
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
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
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 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.
Time frame: 2 years
Disease control rate
Disease control rate defined as CR + PR + stable disease \[SD\]
Time frame: 1 year
Overall Survival (OS)
OS defined as the time from the date the participant started study drug to death for any reason.
Time frame: 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.
Time frame: 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.
Time frame: 2 years
Maximum observed plasma concentration (Cmax) of NKT3447
Maximum observed plasma concentration (Cmax) of NKT3447
Time frame: 1 month
Time to maximum observed plasma concentration of NKT3447 (Tmax)
Time to maximum observed plasma concentration of NKT3447 (Tmax)
Time frame: 1 month
Observed trough concentration of NKT3447 (Ctrough)
Observed trough concentration of NKT3447 (Ctrough)
Time frame: 88 weeks
Area under the plasma concentration-time curve (AUC0-t) of NKT3447
Area under the plasma concentration-time curve (AUC0-t) of NKT3447
Time frame: 1 month
Apparent clearance (CL/F)
Apparent clearance (CL/F)
Time frame: 1 month
Apparent volume of distribution (V/F)
Apparent volume of distribution (V/F)
Time frame: 1 month
Half-life (t1/2)
Half-life (t1/2)
Time frame: 1 month
Accumulation ratio (AR)
Accumulation ratio (AR)
Time frame: 1 month
Plan to share: No — IPD are not planned to be shared at this time
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This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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NiKang Therapeutics, Inc.