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 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by NiKang Therapeutics, Inc. · Phase 1, Interventional, and Treatment
Among 645 studies in Triple Negative Breast Neoplasms with a site in United States — 164 open to participants now, 264 under way, 16 of them phase 3. Triple Negative Breast Neoplasms · United States.
Among the 645 studies in Triple Negative Breast Neoplasms with a site in United States, this one is the 52nd largest by planned enrollment of the 605 interventional ones that give a count, is one of 47 that started in 2025, is one of 246 in phase 1, reaches primary completion later than 138 of the 263 other live ones, and was the 587th registered.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 446 are open to participants now.
Browse Triple Negative Breast Neoplasms studies →164 of the 645 studies in Triple Negative Breast Neoplasms with a site in United States are open now. Recruiting first, the newest first:
University of Alabama at Birmingham · Sites in United States
Medical University of South Carolina · Sites in United States
National Cancer Institute (NCI) · Sites in United States
National Cancer Institute (NCI) · Sites in United States
City of Hope Medical Center · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 332 Triple Negative Breast Neoplasms studies recruiting now, 232 (70%) set no upper age limit and 85 (26%) stop at 75 or younger; 12 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
645 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 353 · Phase 2 300 · Phase 3 29
First in 2001; this study’s year is marked. 47 started in 2025.
This study's planned enrollment of 361 is above the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Median enrollment 52 across the 605 interventional studies, 90 across the 38 observational. Of the 338 that completed or were terminated, 179 (53%) have results posted.
This tab as a report to print or save as PDF → With an account.
319 of 645 have an industry lead sponsor. The 10 most frequent:
NiKang Therapeutics, Inc. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
NiKang Therapeutics, Inc. has 3 studies filed under Triple Negative Breast Neoplasms — fewer than ten, so there is no comparison to draw.
93 of the studies in Triple Negative Breast Neoplasms with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05382286Phase 3Gilead SciencesStudy of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer | 2027-02 |
| NCT05633654Phase 3Gilead SciencesStudy of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63) | 2027-06 |
| NCT04768426Stanford UniversitySerial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer | 2026-11 |
| NCT06545331ExelixisStudy of XB010 in Subjects With Solid Tumors | 2026-11-23 |
| NCT02276443M.D. Anderson Cancer CenterMolecular Testing and Imaging in Improving Response in Patients With Stage I-III Triple-Negative Breast Cancer Receiving Chemotherapy MDACC Breast Moonshot Initiative | 2026-11-30 |
Among the 645 studies in Triple Negative Breast Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Jul 2027, 28 months after the start.
Of 135 industry-sponsored phase 1 interventional studies under Triple Negative Breast Neoplasms, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 70. This study's planned 28 months is below that.
Counting every sponsor, half of 207 studies reached it within 54 months; a quarter within 35 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Triple Negative Breast Neoplasms →
NiKang Therapeutics, Inc.