Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06264921
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-02-09
Brief Title:
A Study With NKT3447 for Adults With AdvancedMetastatic Solid Tumors
Sponsor:
NiKang Therapeutics Inc
Organization:
NiKang Therapeutics Inc
Study Overview
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 AdvancedMetastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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 11b 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 advancedmetastatic 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
1 Ovarian cancer
2 Endometrial cancer
3 Gastric cancer or gastroesophageal junction cancer
4 Small cell lung cancer
5 Triple-negative breast cancer human epidermal growth factor receptor 2 estrogen receptor progesterone receptor negative
6 Estrogen receptorprogesterone-receptor human epidermal growth factor receptor 2 negative HER2- breast cancer must have progressed following treatment with a CDK46 inhibitor and not suitable for endocrine therapy
7 Other solid tumors with CCNE1 amplification as determined by fluorescence in situ hybridization quantitative polymerase chain reaction or next generation sequencing by local liquid or tissue biopsy
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 andor 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
Dose Escalation
1 Ovarian cancer
2 Endometrial cancer
3 Gastric cancer or gastroesophageal junction cancer
4 Small cell lung cancer
5 Triple-negative breast cancer human epidermal growth factor receptor 2 estrogen receptor progesterone receptor negative
6 Estrogen receptorprogesterone-receptor human epidermal growth factor receptor 2 negative HER2- breast cancer must have progressed following treatment with a CDK46 inhibitor and not suitable for endocrine therapy
7 Other solid tumors with CCNE1 amplification as determined by fluorescence in situ hybridization quantitative polymerase chain reaction or next generation sequencing by local liquid or tissue biopsy
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None