A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
NiKang Therapeutics, Inc.
Study ID
NCT06586957
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Endometrial Carcinoma
  • Advanced Gastric Carcinoma
  • Advanced Ovarian Carcinoma
  • Advanced Solid Tumor
  • CCNE1 Amplification
  • Endometrial Diseases
  • Endometrial Neoplasms
  • Gastric Cancer
  • Hormone Receptor Negative Breast Carcinoma
  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
  • Metastatic Endometrial Cancer
  • Metastatic Endometrial Carcinoma
  • Metastatic Gastric Cancer
  • Metastatic Gastric Carcinoma
  • Metastatic Ovarian Carcinoma
  • Metastatic Tumor
  • Ovarian Cancer
  • Ovarian Carcinoma
  • Ovarian Neoplasms
  • Platinum-refractory Ovarian Carcinoma
  • Platinum-resistant Ovarian Cancer
  • Progesterone-receptor-positive Breast Cancer
  • Small Cell Lung Cancer
  • Small Cell Lung Carcinoma
  • Solid Tumor
  • Solid Tumor, Adult
  • Triple Negative Breast Cancer
  • Triple Negative Breast Neoplasms

Eligibility Criteria

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

Interventions

  • NKT3964 — DRUG
    Oral CDK2 Degrader

Study Details

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 expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).

Key Dates

Start date
Sep 19, 2024
Status verified
Apr 2026
Primary completion
Jan 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Dose escalation will assess the safety, efficacy, and PK/PD data of oral dosing NKT3964 at increasing dosage levels to determine the MTD and/or preliminary RDEs.
  • Experimental: Dose Expansion
    Dose expansion will include the RDE selected to determine the preliminary antitumor activity and the RP2D.

Primary Outcome Measure

Number of Participants with Dose Limiting Toxicity (DLT) events [ Time Frame: 28 Days ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
University of Arkansas Medical SchoolLittle RockArkansas72205
Maroof Zafar, MD
[email protected]
501-749-6531
Michael Birrer, MD (PRINCIPAL_INVESTIGATOR)
University of California - Los AngelesLos AngelesCalifornia90095
Gottfried Konecny, MD (PRINCIPAL_INVESTIGATOR)
UCSFSan FranciscoCalifornia94158-
SCRI at HealthOneDenverColorado80218
Front Desk
[email protected]
720-754-2610
Gerald Falchook, MD (PRINCIPAL_INVESTIGATOR)
Florida Cancer Specialists & Research InstituteLake MaryFlorida32746-
AdventHealth Cancer InstituteOrlandoFlorida32804
Advent Health Oncology Research
[email protected]
407-303-2090
Guru Sonpavde, MD (PRINCIPAL_INVESTIGATOR)
Emory Winship Cancer InstituteAtlantaGeorgia30322
Winship Referrals
[email protected]
404-778-1900
Jennifer Scalici, MD (PRINCIPAL_INVESTIGATOR)
Augusta UniversityAugustaGeorgia30912
Sharad Ghamande, MD (PRINCIPAL_INVESTIGATOR)
University of KansasFairwayKansas66205-
Dana Farber Cancer InstituteBostonMassachusetts02215
Elizabeth Lee, MD
[email protected]
877-338-7425
Elizabeth LEE, MD (PRINCIPAL_INVESTIGATOR)
John Theurer Cancer Center at Hackensack UMCHackensackNew Jersey07601
Oncology Clinical Research Referral Office
[email protected]
551-996-1777
Martin Gutierrez, MD (PRINCIPAL_INVESTIGATOR)
Sidney Kimmell Cancer Center - Jefferson HealthPhiladelphiaPennsylvania19107
Sarah Cannon Research Institute
844-482-4812
Ida Micaily, MD (PRINCIPAL_INVESTIGATOR)
UPMCPittsburghPennsylvania15213-
Sarah Cannon Research Institute (SCRI)NashvilleTennessee37203
Kate Hall
[email protected]
629 - 250 - 9081
Denise Yardley, MD (PRINCIPAL_INVESTIGATOR)
NEXT OncologyAustinTexas78758
Suhrutha Bushan
[email protected]
7376105202
Sheena Sahota, MD (PRINCIPAL_INVESTIGATOR)
UT SouthwesternDallasTexas75235
David Miller, MD
[email protected]
833-722-6237
David Miller, MD (PRINCIPAL_INVESTIGATOR)
Intermountain HealthSalt Lake CityUtah84145
Joshua Kunz, MD
[email protected]
801-408-4712
Caroline Nebhan, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22903
Chrystal Axford
[email protected]
434-924-2745
Linda Duska, MD (PRINCIPAL_INVESTIGATOR)
NEXT VirginiaFairfaxVirginia22031
Maybelle De La Rosa
[email protected]
703-783-4518
Alexander Spira, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Little Rock, AR

By condition
Gastric cancerOvarian cancerLung cancerBreast cancer
By specialty
OncologyGI oncologyGynecologic oncologyWomen's healthLung oncologyLung diseaseBreast oncology
By research site
University of Arkansas Medical School· Little Rock, ARUniversity of California - Los Angeles· Los Angeles, CAUCSF· San Francisco, CASCRI at HealthOne· Denver, COFlorida Cancer Specialists & Research Institute· Lake Mary, FLAdventHealth Cancer Institute· Orlando, FL

Related Studies