A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

NCT07029399
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
361
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Lead sponsor
NiKang Therapeutics, Inc.
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Start date
2025-03-25
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Number of sites
18
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Summary
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: * What is the recommended dose for expansion and/or Phase 2, for both monotherapy and in combination with ET * What medical issues/symptoms do participants experience when taking NKT5097 as monotherapy as well as in combination with ET
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Short title
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
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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 Oral Selective CDK2/CDK4 Dual Degrader NKT5097 in Adults With Advanced/Metastatic Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-12-31
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First posted
2025-06-19
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Registry last updated
2026-08-28
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Primary completion date
2027-07-31
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Start date
2025-03-25
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Participants
361
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Participant count basis
Estimated
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Planned participants
361
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Protocol amendments
2
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Number of sites
18
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
NiKang Therapeutics, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07029399
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ClinicalTrials.gov ID
NCT07029399
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Registry record
Open registry record
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Allocation
Not randomised
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Incidence of dose-limiting toxicities as Assessed by CTCAE

    Timeframe: From enrollment through end of safety monitoring period of 28 days from first dose

  1. Incidence of adverse events (AEs) as defined by CTCAE Version 5

    Timeframe: From enrollment through end of treatment up to 2 years

  2. Maximum concentration Cmax after a single dose and multiple doses

    Timeframe: Day 1 and Day 15 of Cycle 1 (Cycle 1 is 28 days)

  3. 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)

    Timeframe: Day 1 and Day 15 of Cycle 1 ((Cycle 1 is 28 days)

  4. Maximum concentration (Cmax) when dosed with and without food

    Timeframe: Day 1 and Day 2 of Cycle 1 (Cycle 1 is 28 days)

  5. Area under the concentration-time curve (AUC last) when dosed with and without food from dosing through the last timepoint with quantifiable concentration (Tlast)

    Timeframe: Day 1 through Day 3 of Cycle 1 (Cycle 1 is 28 days)

  6. Time to maximum plasma concentration (Tmax) after a single dose and multiple doses

    Timeframe: Day 1 through Day 3 and Day 15 of Cycle 1 (Cycle 1 is 28 days)

  7. Investigator-assessed ORR by RECIST v1.1

    Timeframe: From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months

  8. Investigator-assessed PFS by RECIST v1.1

    Timeframe: From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months

  9. Duration of Response (DOR)

    Timeframe: From enrollment (Day 1) through end of treatment (up to 3 years) with an average of 4 months

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Able to provide written informed consent
  • Advanced unresectable or metastatic solid tumor (Part 1, 2 & 3 only)
  • Advanced unresectable or metastatic HR+/HER2- breast cancer (Part 4 & 5 only)
  • Refractory to or unable to tolerate existing therapies (Part 1, 2 & 4 only)
  • Measurable or evaluable disease (Part 1, 2, & 4 only).
  • Measurable disease (Part 3 & 5 only)
  • Eighteen years of age or older
  • ECOG status of 0 or 1
  • Adequate organ function
  • Patients with female reproductive organs must be surgically sterile, post- menopausal or willing to use effective contraception per protocol
  • Patients who are capable of insemination must be willing to use highly effective contraception and to refrain from sperm donation during treatment and for 28 days after the last dose
  • Able to swallow oral meds
  • Willing to provide tumor tissue

  • Advanced solid tumor that is a candidate for curative treatment
  • History of another malignancy except for the following: adequately treated local basal cell or squamous carcinoma of the skin, in situ cervical cancer, adequately treated papillary noninvasive bladder cancer, other adequately treated Stage I or Stage II cancers currently in complete remission
  • Not recovered from the effects of prior anticancer therapy
  • Clinically significant cardiovascular event, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months
  • Known active CNS metastases and/or carcinomatous meningitis
  • Active interstitial lung disease requiring treatment
  • History of uveitis, retinopathy, or other clinically significant retinal disease
  • Major surgery within 30 days of administration of first dose
  • Active uncontrolled infectious disease
  • Significant liver disease (Child Pugh class B or C)
  • Should not have received any prior selective investigational inhibitors or degraders (Part 5 only)
Sources for eligibility
clinicaltrials.gov

  • City of HopeDuarte, United StatesRecruiting
  • UC San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting
  • Sarah Cannon Research Institute at HealthONEDenver, United StatesRecruiting
  • Yale Cancer CenterNew Haven, United StatesRecruiting
  • SCRI Florida Cancer Specialists - SarasotaSarasota, United StatesRecruiting
  • University of IowaIowa City, United StatesRecruiting
  • Dana-Farber Cancer InstituteBoston, United StatesRecruiting
  • South Texas Accelerated Research Therapeutics (START) MidwestGrand Rapids, United StatesRecruiting
  • Washington UniversitySt Louis, United StatesRecruiting
  • Comprehensive Cancer Centers of NevadaLas Vegas, United StatesRecruiting
  • Cleveland ClinicCleveland, United StatesRecruiting
  • UPMC Hillman Cancer CenterPittsburgh, United StatesRecruiting
  • University of Texas Southwestern Medical CenterDallas, United StatesRecruiting
  • MD Anderson Cancer CenterHouston, United StatesRecruiting
  • South Texas Accelerated Research Therapeutics (START) San AntonioSan Antonio, United StatesRecruiting
  • South Texas Accelerated Research Therapeutics (START) Mountain RegionWest Valley City, United StatesRecruiting
  • NEXT VirginiaFairfax, United StatesRecruiting
  • West Virginia UniversityMorgantown, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (2)