Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer (INX-315-01)

March 27, 2026 updated by: Incyclix Bio

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study INX-315-01 is a first-in-human, Phase 1/2, open-label, dose escalation and dose-expansion study to evaluate the safety, PK, and preliminary antitumor activity of INX-315 in patients with advanced/metastatic cancers. The study will be conducted in 3 parts: Part A (dose escalation and combination therapy) and Part B (ovarian cancer dose expansion) and Part C (breast cancer dose escalation lead-in and expansion).

Part A is the dose-escalation portion of the study to evaluate the safety, tolerability, and PK of INX-315 monotherapy. Dosing decisions will be guided using a Bayesian optimal interval (BOIN) design. Up to 60 patients with recurrent advanced/metastatic cancer, including patients with HR+/HER2- breast cancer who progressed on a prior CDK4/6i regimen, and solid tumors, including ovarian cancer with known amplification of CCNE1 are planned to be enrolled in Part A.

Dose-limiting toxicities (DLTs) will be assessed during the first treatment cycle, i.e., the first 28 days of treatment (the DLT period). Patients who are evaluable for DLT assessment are those patients who are enrolled, received >=80% of the planned study drug doses during the DLT assessment period, and complete the 28-day DLT period.

Additionally, Part A will have two cohorts that will include INX-315 plus fulvestrant in HR+/HER2- patients who have have had prior treatment with CDK4/6i.

Part B will expand at least two dose levels determined by the SMC. Part B will enroll patients with platinum-refractory or platinum-resistant advanced/ metastatic ovarian cancer patients with CCNE1 amplifications. Part B will open for enrollment once the SMC has selected the dose levels to be evaluated from the Part A portion of the study. Part A patients cannot re-join or continue the study in Part B. Approximately 30 patients will be equally randomized to receive one of the dose levels of INX-315.

Part C will be a dose escalation and expansion cohort, patients with HR+/HER2- breast cancer will be enrolled in this cohort. Patients will receive INX-315 along with abemaciclib and fulvestrant. Approximately 50 patients will be enrolled in Part C.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • South Brisbane, Australia, 4101
        • Recruiting
        • Mater Hospital
        • Principal Investigator:
          • Catherine Shannon, MD
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Peninsula and South Eastern Haematology & Oncology Group
        • Principal Investigator:
          • Vinod Ganju, MD
        • Contact:
      • Parkville, Victoria, Australia, 3052
        • Recruiting
        • Peter MacCallum Cancer Center
        • Contact:
        • Principal Investigator:
          • George Au-Yeung, MD
  • United States
    • Florida
      • Orlando, Florida, United States, 32827
        • Recruiting
        • Florida Cancer Specialists
        • Principal Investigator:
          • Cesar Perez, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory Winship Cancer Institute
        • Principal Investigator:
          • Kevin M Kalinsky, MD
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Georgia Cancer Center at Augusta University
        • Contact:
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Recruiting
        • Fort Wayne Medical Oncology and Hematology
        • Principal Investigator:
          • Sunil Babu, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
        • Contact:
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Sheheryar Kabraji, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Cancer Institute (LCI)- Atrium Health
        • Principal Investigator:
          • Antoinette Tan, MD
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke Cancer Center/ DUMC
        • Principal Investigator:
          • Carey Anders, MD
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Gabrail Cancer Research Center
        • Contact:
        • Principal Investigator:
          • Nashat Gabrail, MD
    • Texas
      • Dallas, Texas, United States, 75390
      • Dallas, Texas, United States, 75039
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Oncology Consultants
        • Principal Investigator:
          • Julio Peguero, MD
        • Contact:
      • Houston, Texas, United States, 77054
    • Washington
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Northwest Medical Specialties, PLLC
        • Principal Investigator:
          • Jorge Chaves, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Advanced unresectable or metastatic HR+/HER2- BC that has progressed following treatment with a CDK4/6 inhibitor in the adjuvant or advanced/metastatic setting.
  2. Advanced/ metastatic platinum-resistant or platinum-refractory high grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, with known amplification of CCNE-1 that progressed after standard systemic therapy
  3. Advanced or metastatic solid tumor with known amplification of CCNE-1 that has progressed after standard therapy, been intolerant to or is ineligible for standard therapy
  4. At least one measurable lesion as defined by RECIST v1.1 that has not previously been irradiated
  5. ECOG performance status score of 0 or 1.

  6. Adequate organ function as demonstrated by the following laboratory values:

    1. Hemoglobin ≥ 9.0 g/dL
    2. Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
    3. Platelet count ≥ 100 × 10^9/L
    4. Estimated glomerular filtration rate (eGFR) of ≥60 mL/min
    5. Part A and B: Total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN; ≤ 5 × ULN in the presence of liver metastases Part C: Patients with Gilbert's syndrome with a total bilirubin ≤ 2.0 × ULN and direct bilirubin within normal limits
  7. Negative pregnancy test

Exclusion Criteria:

  1. Have received previous therapy with a CDK2/4/6 inhibitor or CDK2 inhibitor.
  2. Have central nervous system (CNS) metastases or spinal cord compression that is associated with progressive neurological symptoms or requires corticosteroids (within 4 weeks of enrollment) to control the CNS disease.
  3. Have known intracranial hemorrhage and/or bleeding diatheses.
  4. Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.
  5. Have clinically active ongoing interstitial lung disease (ILD) of any etiology, including drug-induced ILD, and radiation pneumonitis within 28 days prior to initiation of study treatment.
  6. Resting QTcF > 470 msec, a history of prolonged QT syndrome or Torsades de pointes, or a familial history of prolonged QT syndrome.
  7. Uncontrolled, cardiovascular disease (including hypertension) with or without medication
  8. History of other malignancies, except for the following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (3) other curatively treated solid tumor with no evidence of disease for ≥ 3 years.
  9. Known HIV infection, including AIDS-related illness, or have active, uncontrolled infection (viral, bacterial, or fungal), including tuberculosis, hepatitis B virus, hepatitis C virus, or COVID-19 infection (symptoms and a positive test result).
  10. Requires treatment with a prohibited medication or herbal remedy that cannot be discontinued at least 2 weeks before the start of study drug administration.
  11. Have planned or anticipation of the need for major surgical procedure within 28 days of the first dose of study drug (procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures).
  12. Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, or other study procedures and study restrictions.
  13. Radical radiotherapy within 28 days prior to study entry or palliative radiotherapy within 2 weeks prior to study entry.
  14. Systemic anti-cancer therapy within 21 days or at least 5 half-lives, whichever is less, prior to the first dose of the study drug
  15. Prior irradiation to > 25% of the bone marrow
  16. Previous high-dose chemotherapy requiring prior stem cell transplant
  17. Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry.
  18. Known or suspected hypersensitivity to active ingredient/excipients in INX-315 or fulvestrant or abemaciclib.
  19. Known difficulty in swallowing or tolerating oral medications, or conditions which would impair absorption of oral medications such as active inflammatory gastrointestinal disease, uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction/motility disorder/active inflammation, malabsorption syndrome, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.
  20. Has a serious and/or uncontrolled pre-existing medical condition(s) that, in the judgment of the Investigator or the Sponsor, would preclude participation in this study (for example but not limited to, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Dose Escalation
Multiple doses of INX-315 monotherapy, oral administration
Drug: INX-315
Oral administration
Experimental: Part B: Ovarian Dose Expansion
INX-315 monotherapy, oral administration
Drug: INX-315
Oral administration
Experimental: Part C: HR+/HER2- BC Dose Expansion
INX-315 in combination with abemaciclib (oral administration) and fulvestrant (IM)
Drug: INX-315
Oral administration
Drug: Fulvestrant
Fulvestrant will be combined with INX-315
Other Names:
  • Faslodex
Drug: Abemaciclib
Abemaciclib will be combined with INX-315
Other Names:
  • Verzenio
Experimental: Part A INX-315 + Fulvestrant
INX-315 dose plus Fulvestrant 500mg (IM)
Drug: INX-315
Oral administration
Drug: Fulvestrant
Fulvestrant will be combined with INX-315
Other Names:
  • Faslodex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part A: Evaluate the occurrence of dose-limiting toxicities (DLTs) during Cycle 1
Time Frame: 28 days
28 days
Part A: Recommend at least two doses of INX-315 to be evaluated in the expansion phase
Time Frame: Up to 12 months
Up to 12 months
Part B: Overall response rate (ORR)
Time Frame: Up to 36 months
Up to 36 months
Part B: Selection of Recommended Phase 2 Dose (RP2D)
Time Frame: Up to 36 months
Up to 36 months
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
Up to 12 months
Part C Evaluate the incidents of treatment emergent adverse events and laboratory abnormalities for patients in combination treatment (INX_315+abemaciclib+fulvestrant)
Time Frame: Up to 12 months
Up to 12 months
Part C - Evaluate the antitumor activity of INX-315 in combination with abemaciclib and fulvestrant
Time Frame: Up to 12 months
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: Up to 36 months
Up to 36 months
Part A: Overall response rate (ORR)
Time Frame: Up to 36 months
Up to 36 months
Progression free survival (PFS)
Time Frame: Up to 36 months
Up to 36 months
Time to progression (TTP)
Time Frame: Up to 36 months
Up to 36 months
Characterize the maximum plasma concentration (Cmax)
Time Frame: Cycle 1 Day 1 and Day 15
Cycle 1 Day 1 and Day 15
Characterize the time to maximum plasma concentration (Tmax)
Time Frame: Cycle 1 Day 1 and Day 15
Cycle 1 Day 1 and Day 15
Characterize the Area under the plasma concentration versus time curve from time 0 to the end of the dosing interval (AUC0-24h)
Time Frame: Cycle 1 Day 1 and Day 15
Cycle 1 Day 1 and Day 15
Characterize the terminal half-life (t1/2)
Time Frame: Cycle 1 Day 1 and Day 15
Cycle 1 Day 1 and Day 15
Characterize the oral clearance (CL/F)
Time Frame: Cycle 1 Day 1 and Day 15
Cycle 1 Day 1 and Day 15
Disease control rate (DCR)
Time Frame: Up to 36 months
Up to 36 months
Duration of response (DOR)
Time Frame: Up to 36 months
Up to 36 months
Part C Determine recommended dose of INX-315 in combination treatment for further study
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyclix Bio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

February 9, 2023

First Submitted That Met QC Criteria

February 9, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INX-315-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Data will be shared at the completion of the study, expected release date will be in 2028

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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