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

Part of paid clinical trials in La Jolla, California.

Sponsor
NiKang Therapeutics, Inc.
Study ID
NCT07029399
Phase
PHASE1
Status
Recruiting
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Conditions

  • CCNE1 Amplified Advanced Solid Tumors
  • HR+ Breast Cancer
  • HR+ HER2- Breast Cancer
  • Triple Negative Breast Cancer (TNBC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NKT5097 CDK2/CDK4 dual degrader — DRUG
    NKT5097 will be distributed in tablet form and dosed daily or twice a day
  • Fulvestrant — DRUG
    Fulvestrant will be administered as an injection and dosed on C1D1, C1D15 and Day 1 of every cycle thereafter.
  • Letrozole — DRUG
    Letrozole will be administered orally once daily.

Study Details

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

Key Dates

Start date
Mar 25, 2025
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
361 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Dose Escalation
    Escalation of orally administered NKT5097
  • Experimental: Part 2 Food Effect
    Orally administered NKT5097 with and without meal
  • Experimental: Part 3 Expansion
    Expansion of dose levels based upon safety and PK following Part 1 escalation.
  • Experimental: Part 4 Combination Dose Escalation
    Escalation of orally administered NKT5097 in combination with Endocrine Therapy (ET)
  • Experimental: Part 5 Combination Expansion
    Expansion of dose levels based upon safety and PK following Part 4 escalation

Primary Outcome Measure

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 ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92037
Cristal Martinez
[email protected]
858-822-5223
Rebecca Shatsky, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute at HealthONEDenverColorado80218
SCRI Contact Email
[email protected]
720-754-2610
Gerald Falchook, MD (PRINCIPAL_INVESTIGATOR)
Yale Cancer CenterNew HavenConnecticut06520
Priscilla Steve
[email protected]
203-785-4069
Adriana Kahn, MD (PRINCIPAL_INVESTIGATOR)
SCRI Florida Cancer Specialists - SarasotaSarasotaFlorida34232
Carly Taylor
[email protected]
941-377-9993
Judy Wang, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02115
Dana Faber Institutional clinical.gov contact
877-338-7425
Antonio Giordano, MD (PRINCIPAL_INVESTIGATOR)
South Texas Accelerated Research Therapeutics (START) MidwestGrand RapidsMichigan49546
Ashley Spagnuolo
[email protected]
616.954.5552
Manish Sharma (PRINCIPAL_INVESTIGATOR)
Washington UniversitySt LouisMissouri63110
Katlyn Kraft
[email protected]
314-747-5440
Faisal Fa'ak, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Cancer Answer
[email protected]
216-444-7923
Azka Ali, MD (PRINCIPAL_INVESTIGATOR)
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Julie Urban
[email protected]
412-623-7396
Marija Balic, MD, PhD, MBA (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Jennifer Knight
[email protected]
214-645-7097
Nisha Unni, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Ileana Gutierrez
[email protected]
832-829-2161
Timothy Yap, MD (PRINCIPAL_INVESTIGATOR)
South Texas Accelerated Research Therapeutics (START) San AntonioSan AntonioTexas78229
Isabel Jimenez
[email protected]
210-593-5265
Amita Patnaik (PRINCIPAL_INVESTIGATOR)
South Texas Accelerated Research Therapeutics (START) Mountain RegionWest Valley CityUtah84119
Marie Asay
[email protected]
801-907.4770
William McKean (PRINCIPAL_INVESTIGATOR)
NEXT VirginiaFairfaxVirginia22031
Blake Patterson
[email protected]
703-783-4505
Alexander Spira (PRINCIPAL_INVESTIGATOR)

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By research site
UC San Diego Moores Cancer Center· La Jolla, CASarah Cannon Research Institute at HealthONE· Denver, COYale Cancer Center· New Haven, CTSCRI Florida Cancer Specialists - Sarasota· Sarasota, FLDana-Farber Cancer Institute· Boston, MASouth Texas Accelerated Research Therapeutics (START) Midwest· Grand Rapids, MI

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