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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

March 28, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

June 30, 2026

Conditions
Breast CancerBreast Cancer MetastaticHormone Receptor Positive TumorHuman Epidermal Growth Factor 2 Negative Carcinoma of BreastOvarian CancerCCNE1 AmplificationSolid TumorAdvanced CancerMetastatic Cancer
Interventions
DRUG

INX-315

Oral administration

DRUG

Fulvestrant

Fulvestrant will be combined with INX-315

DRUG

Abemaciclib

Abemaciclib will be combined with INX-315

Trial Locations (17)

3052

RECRUITING

Peter MacCallum Cancer Center, Parkville

4101

RECRUITING

Mater Hospital, South Brisbane

14263

RECRUITING

Roswell Park Cancer Institute, Buffalo

27705

RECRUITING

Duke Cancer Center/ DUMC, Durham

28204

RECRUITING

Levine Cancer Institute (LCI)- Atrium Health, Charlotte

30322

RECRUITING

Emory Winship Cancer Institute, Atlanta

30912

RECRUITING

Georgia Cancer Center at Augusta University, Augusta

32746

RECRUITING

Florida Cancer Specialists, Lake Mary

44718

RECRUITING

Gabrail Cancer Research Center, Canton

46804

RECRUITING

Fort Wayne Medical Oncology and Hematology, Fort Wayne

48201

RECRUITING

Karmanos Cancer Institute, Detroit

75039

RECRUITING

Next Oncology, Dallas

75390

RECRUITING

UTSW Medical Center, Dallas

77030

NOT_YET_RECRUITING

Oncology Consultants, Houston

77054

RECRUITING

Next Oncology, Houston

98405

RECRUITING

Northwest Medical Specialties, PLLC, Tacoma

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyclix Bio

INDUSTRY

NCT05735080 - Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer | Biotech Hunter | Biotech Hunter