A Phase 1 interventional study of NKT5097 CDK2/CDK4 dual degrader and Fulvestrant in HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC) and CCNE1 Amplified Advanced Solid Tumors, sponsored by NiKang Therapeutics, Inc.. Recruiting at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by NiKang Therapeutics, Inc. · Phase 1, Interventional, and Treatment
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include:
This First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of NKT5097, a novel dual protein degrader of CDK2 and CDK4, is split into 3 Parts:
Part 1: Monotherapy Dose Escalation in selected advanced/metastatic non-CNS primary solid tumors will be enrolled based on a projected total of 5 dose levels
Part 2: Food Effect Analysis: Subjects with solid tumors (as noted in Part 1) will be enrolled (by backfilling selected dose cohorts) to evaluate the effect of dosing with food on NKT5097.
Part 3: Monotherapy Tumor-specific Expansion: Subjects may be enrolled (by backfilling selected dose cohorts) into each selected tumor-specific cohort. One or more of these cohorts may be opened at the discretion of the Sponsor in consultation with the DEC
Part 4: Combination Dose Escalation with ET in selected HR+/HER2- breast cancer will be enrolled based on a projected 2 dose levels
Part 5: Combination Dose Expansion with ET in HR+/HER2- breast cancer in one or more various cohorts
In addition to the above, the study will explore pharmacokinetics, various pharmacodynamic biomarkers, gene mutations, and tumor responses such as PFS and DOR.
Exclusion Criteria:
Escalation of orally administered NKT5097
Drug: NKT5097 CDK2/CDK4 dual degrader
Orally administered NKT5097 with and without meal
Drug: NKT5097 CDK2/CDK4 dual degrader
Expansion of dose levels based upon safety and PK following Part 1 escalation.
Drug: NKT5097 CDK2/CDK4 dual degrader
Escalation of orally administered NKT5097 in combination with Endocrine Therapy (ET)
Drug: NKT5097 CDK2/CDK4 dual degrader · Drug: Fulvestrant · Drug: Letrozole
Expansion of dose levels based upon safety and PK following Part 4 escalation
Drug: NKT5097 CDK2/CDK4 dual degrader · Drug: Fulvestrant · Drug: Letrozole
NKT5097 will be distributed in tablet form and dosed daily or twice a day
Fulvestrant will be administered as an injection and dosed on C1D1, C1D15 and Day 1 of every cycle thereafter.
Letrozole will be administered orally once daily.
Incidence of dose-limiting toxicities as Assessed by CTCAE
Time frame: From enrollment through end of safety monitoring period of 28 days from first dose
Incidence of adverse events (AEs) as defined by CTCAE Version 5
Time frame: From enrollment through end of treatment up to 2 years
Maximum concentration Cmax after a single dose and multiple doses
Time frame: Day 1 and Day 15 of Cycle 1 (Cycle 1 is 28 days)
Area under the concentration-time curve (AUC last) after a single dose and multiple doses from first dose through the last timepoint with quantifiable concentration (Tlast)
Time frame: Day 1 and Day 15 of Cycle 1 ((Cycle 1 is 28 days)
Maximum concentration (Cmax) when dosed with and without food
Time frame: Day 1 and Day 2 of Cycle 1 (Cycle 1 is 28 days)
Area under the concentration-time curve (AUC last) when dosed with and without food from dosing through the last timepoint with quantifiable concentration (Tlast)
Time frame: Day 1 through Day 3 of Cycle 1 (Cycle 1 is 28 days)
Time to maximum plasma concentration (Tmax) after a single dose and multiple doses
Time frame: Day 1 through Day 3 and Day 15 of Cycle 1 (Cycle 1 is 28 days)
Investigator-assessed ORR by RECIST v1.1
Time frame: From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months
Investigator-assessed PFS by RECIST v1.1
Time frame: From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months
Duration of Response (DOR)
Time frame: From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months
Plan to share: No
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Triple Negative Breast Neoplasms→
NiKang Therapeutics, Inc.