Status:
RECRUITING
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Lead Sponsor:
NiKang Therapeutics, Inc.
Conditions:
Solid Tumor
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
Inclusion Criteria: \- Must have a pathologically confirmed, advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. For Part...
Eligibility Criteria
Inclusion
- \- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 only: subjects must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.
- Dose Escalation:
- Ovarian cancer
- Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)
- Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification
- Small cell lung cancer (SCLC)
- Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)
- HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and is not suitable for endocrine therapy \[ET\])
- Other solid tumors with CCNE1 amplification
- Dose Expansion:
- Part 2A: HR+ and HER2- breast cancer that is locally advanced and unresectable (Stage III) or metastatic (Stage IV); previously treated with ≥1 line of standard of care (SOC) including CDK4/6 inhibitor plus ET and not suitable for further ET. Subjects must have progressed after receiving therapy for ≥3 months in the metastatic setting or for ≥6 months in the adjuvant setting. Subjects must have received ≤2 lines of systemic cytotoxic therapy (chemotherapy or cytotoxic antibody drug conjugate \[ADC\]) in the metastatic setting..
- Part 2B: Advanced platinum-based-chemotherapy resistant or refractory epithelial ovarian/fallopian/primary peritoneal carcinoma or clear cell ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least one platinum containing therapy and previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease.
- Part 2C: Advanced unresectable or metastatic gastric, GEJ or esophageal adenocarcinoma with progression on at least one systemic therapy and previously treated with ≤3 prior lines of systemic therapy administered for advanced/metastatic disease, with CCNE1 amplification as determined by NGS by local liquid or tissue test.
- Part 2D: Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease (only 'endometrioid' subtype will require CCNE1 amplification as determined by NGS by local liquid or tissue test).
- Part 2E: Advanced/recurrent uterine carcinosarcoma previously treated with 1 prior platinum-based chemotherapy regimen and ≤3 prior lines of systemic therapy. Prior bevacizumab or PARP inhibitors are allowed and must be at least 3 weeks prior to the start of study drug.
- Have adequate organ function
- Subjects with female reproductive organs must be surgically sterile, post-menopausal, or must be willing to use highly effective method(s) of contraception
- Ability to swallow oral medications.
- Consent to provide archived tumor tissues and paired tumor biopsy at pretreatment
Exclusion
- 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
- History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.
- Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)
- Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment
- Known active CNS metastases and/or carcinomatous meningitis
- Active interstitial lung disease currently requiring treatment
- History of uveitis, retinopathy or other clinically significant retinal disease
- Active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease
- Active wound healing from major surgery within 1 month or minor surgery within 10 days before the first dose of NKT3964.
- Known human immunodeficiency virus (HIV), active hepatitis B or C infection
- Prior investigative treatment with a selective or nonselective CDK2 inhibitor or degrader
- Childs-Pugh class B or C cirrhosis or any other clinically significant liver disorder
- Palliative radiation therapy within 14 days or other radiation therapy within 4 weeks prior to C1D1
Key Trial Info
Start Date :
September 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06586957
Start Date
September 19 2024
End Date
May 1 2029
Last Update
December 30 2025
Active Locations (19)
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1
University of Arkansas Medical School
Little Rock, Arkansas, United States, 72205
2
University of California - Los Angeles
Los Angeles, California, United States, 90095
3
UCSF
San Francisco, California, United States, 94158
4
SCRI at HealthOne
Denver, Colorado, United States, 80218