Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06264921
Other study ID # NKT3447-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date February 23, 2024
Est. completion date May 2025

Study information

Verified date June 2024
Source NiKang Therapeutics, Inc.
Contact Sponsor Contact
Phone 3024155127
Email clinicaltrials@nikangtx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


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: 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 receptor/progesterone-receptor + 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) 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) 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date May 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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: 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 receptor/progesterone-receptor + 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) 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. - Measurable disease per the RECIST v1.1 - An Eastern Cooperative Oncology Group performance status of 0 to 1 - Able to swallow oral medications. Exclusion Criteria: - 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, 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 - Has known human immunodeficiency virus (HIV), active hepatitis B or C infection - Prior CDK2 inhibitor, WEE1 inhibitor, or protein kinase membrane associated tyrosine/threonine 1 inhibitor. - Major surgery within 2 months or minor surgery within 10 days before the first dose of NKT3447

Study Design


Related Conditions & MeSH terms

  • Advanced Endometrial Carcinoma
  • Advanced Gastric Carcinoma
  • Advanced Ovarian Carcinoma
  • Advanced Solid Tumor
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Ovarian Epithelial
  • Endometrial Cancer
  • Endometrial Diseases
  • Endometrial Neoplasms
  • Gastric Cancer
  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
  • Metastatic Endometrial Cancer
  • Metastatic Endometrial Carcinoma
  • Metastatic Gastric Cancer
  • Metastatic Gastric Carcinoma
  • Metastatic Ovarian Carcinoma
  • Metastatic Tumor
  • Neoplasm Metastasis
  • Neoplasms
  • Ovarian Cancer
  • Ovarian Carcinoma
  • Ovarian Neoplasms
  • Platinum-refractory Ovarian Carcinoma
  • Platinum-resistant Ovarian Cancer
  • Small Cell Lung Carcinoma
  • Small-cell Lung Cancer
  • Solid Tumor
  • Solid Tumor, Adult
  • Stomach Neoplasms
  • Triple Negative Breast Cancer
  • Triple Negative Breast Neoplasms
  • Uterine Diseases

Intervention

Drug:
NKT3447
Oral CDK2 inhibitor

Locations

Country Name City State
United States Texas Oncology-Austin Midtown NEXT Oncology Austin Texas
United States The Gabrail Pharmacology Phase 1 Research Center Canton Ohio
United States AdventHealth Cancer Institute Celebration Florida
United States Sarah Cannon Research Institute at HealthONE Denver Colorado
United States START Mountain Region West Valley City Utah

Sponsors (1)

Lead Sponsor Collaborator
NiKang Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 28 days
Primary 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 1 year
Secondary 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. 2 years
Secondary 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. 2 years
Secondary Disease control rate Disease control rate defined as CR + PR + stable disease [SD] 1 year
Secondary Overall Survival (OS) OS defined as the time from the date the participant started study drug to death for any reason. 2 years
Secondary Time to Response (TTR) TTR is defined as the time from first dose to the first documented CR or PR which is subsequently confirmed. 1 year
Secondary 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. 2 years
Secondary Maximum observed plasma concentration (Cmax) of NKT3447 Maximum observed plasma concentration (Cmax) of NKT3447 1 month
Secondary Time to maximum observed plasma concentration of NKT3447 (Tmax) Time to maximum observed plasma concentration of NKT3447 (Tmax) 1 month
Secondary Observed trough concentration of NKT3447 (Ctrough) Observed trough concentration of NKT3447 (Ctrough) 88 weeks
Secondary Area under the plasma concentration-time curve (AUC0-t) of NKT3447 Area under the plasma concentration-time curve (AUC0-t) of NKT3447 1 month
Secondary Apparent clearance (CL/F) Apparent clearance (CL/F) 1 month
Secondary Apparent volume of distribution (V/F) Apparent volume of distribution (V/F) 1 month
Secondary Half-life (t1/2) Half-life (t1/2) 1 month
Secondary Accumulation ratio (AR) Accumulation ratio (AR) 1 month
See also
  Status Clinical Trial Phase
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Withdrawn NCT05201001 - APX005M in Patients With Recurrent Ovarian Cancer Phase 2
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT05156892 - Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer Phase 1
Suspended NCT02432378 - Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Phase 1/Phase 2
Recruiting NCT04533763 - Living WELL: A Web-Based Program for Ovarian Cancer Survivors N/A
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Completed NCT02019524 - Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients Phase 1
Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2