Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer

Part of paid clinical trials in Orlando, Florida.

Sponsor
Incyclix Bio
Study ID
NCT05735080
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Cancer
  • Breast Cancer
  • Breast Cancer Metastatic
  • CCNE1 Amplification
  • Hormone Receptor Positive Tumor
  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
  • Metastatic Cancer
  • Ovarian Cancer
  • Solid Tumor

Eligibility Criteria

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

Interventions

  • INX-315 — DRUG
    Oral administration
  • Fulvestrant — DRUG
    Fulvestrant will be combined with INX-315
  • Abemaciclib — DRUG
    Abemaciclib will be combined with INX-315

Study Details

Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin dependent kinase 2 (CDK2) for the treatment of human cancers. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of INX-315 in patients with recurrent advanced/metastatic cancer, including hormone receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer who progressed on a prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) regimen, and CCNE1-amplified solid tumors who progressed on standard of care treatment. The study will be conducted in 3 parts: Part A (INX-315 monotherapy dose escalation and combination therapy with fulvestrant), Part B (ovarian cancer INX-315 monotherapy dose expansion), and Part C (INX-315 combination therapy with abemaciclib \[a CDK4/6i\] and fulvestrant \[a SERD\] in advanced/metastatic breast cancer; dose escalation and expansion).

Key Dates

Start date
Mar 28, 2023
Status verified
Mar 2026
Primary completion
Jul 31, 2027
Completion
Sep 30, 2027

Study Design

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

Arms

  • Experimental: Part A: Dose Escalation
    Multiple doses of INX-315 monotherapy, oral administration
  • Experimental: Part B: Ovarian Dose Expansion
    INX-315 monotherapy, oral administration
  • Experimental: Part C: HR+/HER2- BC Dose Expansion
    INX-315 in combination with abemaciclib (oral administration) and fulvestrant (IM)
  • Experimental: Part A INX-315 + Fulvestrant
    INX-315 dose plus Fulvestrant 500mg (IM)

Primary Outcome Measure

Part A and B: Evaluate the incidents of treatment emergent adverse events and laboratory abnormalities in INX-315 monotherapy and in combination with fulvestrant [ Time Frame: Up to 12 months ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsOrlandoFlorida32827
Julia Rivera Otero
[email protected]
Cesar Perez, MD (PRINCIPAL_INVESTIGATOR)
Emory Winship Cancer InstituteAtlantaGeorgia30322
Kevin M Kalinsky, MD (PRINCIPAL_INVESTIGATOR)
Georgia Cancer Center at Augusta UniversityAugustaGeorgia30912
Donna Wheatley
[email protected]
Fort Wayne Medical Oncology and HematologyFort WayneIndiana46804
Andrea Vasquez
[email protected]
Sunil Babu, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Meghan Levesque
[email protected]
Antonio Giordano, MD (PRINCIPAL_INVESTIGATOR)
Karmanos Cancer InstituteDetroitMichigan48201
Madeline McGinnis
[email protected]
313-576-9380
Roswell Park Cancer InstituteBuffaloNew York14263
Ask Roswell
[email protected]
800-767-9355
Sheheryar Kabraji, MD (PRINCIPAL_INVESTIGATOR)
Levine Cancer Institute (LCI)- Atrium HealthCharlotteNorth Carolina28204
Antoinette Tan, MD (PRINCIPAL_INVESTIGATOR)
Duke Cancer Center/ DUMCDurhamNorth Carolina27705
Carey Anders, MD (PRINCIPAL_INVESTIGATOR)
Gabrail Cancer Research CenterCantonOhio44718
Carrie Smith, RN
[email protected]
Nashat Gabrail, MD (PRINCIPAL_INVESTIGATOR)
Next OncologyDallasTexas75039
Fope Akinwale
[email protected]
Michael Song, MD (PRINCIPAL_INVESTIGATOR)
UTSW Medical CenterDallasTexas75390
Isabel Valenciana
[email protected]
David Miller, MD (PRINCIPAL_INVESTIGATOR)
Next OncologyHoustonTexas77054
Fope Akinwale
[email protected]
Jennifer Segar, MD (PRINCIPAL_INVESTIGATOR)
Oncology ConsultantsHoustonTexas77030
Site PI
[email protected]
713-600-0913
Julio Peguero, MD (PRINCIPAL_INVESTIGATOR)
Northwest Medical Specialties, PLLCTacomaWashington98405
Sue Quinsey
[email protected]
253-428-8700
Jorge Chaves, MD (PRINCIPAL_INVESTIGATOR)

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Florida Cancer Specialists· Orlando, FLEmory Winship Cancer Institute· Atlanta, GAGeorgia Cancer Center at Augusta University· Augusta, GAFort Wayne Medical Oncology and Hematology· Fort Wayne, INDana-Farber Cancer Institute· Boston, MAKarmanos Cancer Institute· Detroit, MI

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