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CDK2 Inhibitor

INX-315 for Advanced Cancer (INX-315-01 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Incyclix Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Advanced/ metastatic platinum-resistant or platinum-refractory epithelial ovarian cancer (including fallopian tube cancer/primary peritoneal cancer) CCNE1 amplified tumors that progressed after standard systemic therapy
ECOG performance status score of 0 or 1
Must not have
Uncontrolled cardiovascular disease (including hypertension) with or without medication
Known difficulty in swallowing or tolerating oral medications, or conditions which would impair absorption of oral medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing INX-315, a new pill that blocks a protein helping cancer cells grow. It targets patients with advanced cancers who did not respond to other treatments. The drug aims to slow or stop cancer growth by blocking a key protein.

Who is the study for?
This trial is for adults with advanced cancers, including hormone receptor positive breast cancer resistant to CDK4/6 inhibitors, ovarian cancer unresponsive to platinum-based treatments, and solid tumors with CCNE1 amplification after standard therapy. Participants must be in good physical condition (ECOG score of 0 or 1), have measurable lesions not previously treated by radiation, and adequate organ function.
What is being tested?
INX-315 is being tested as an oral treatment targeting CDK2 in patients with various advanced cancers. The study has three parts: determining safe dosage levels (Part A), finding the recommended dose for Phase 2 trials in ovarian cancer patients (Part B), and testing INX-315 combined with other drugs in breast cancer patients who didn't respond to previous treatments (Part C).
What are the potential side effects?
Potential side effects of INX-315 may include reactions related to drug intolerance or allergies, complications from underlying health conditions like cardiovascular disease or infections such as HIV/AIDS. Specific side effects are not listed but will relate to the safety profile of a small molecule inhibitor targeting CDK2.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My ovarian cancer is resistant to platinum-based treatments and has worsened after standard treatment.
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I am fully active or can carry out light work.
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I have a tumor that can be measured and hasn't been treated with radiation.
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My ER+/HER2- breast cancer has worsened after CDK4/6 inhibitor treatment.
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My cancer has worsened after standard treatment or I cannot receive standard treatment.
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My organ functions are within normal ranges according to recent tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart condition or high blood pressure is not well-managed, even with medication.
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I have trouble swallowing or absorbing pills.
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I have a heart condition that affects my heart's electrical activity.
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I have not had intense radiotherapy in the last 28 days or any palliative radiotherapy in the last 2 weeks.
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I am not planning to have any major surgery within 28 days of starting the study drug.
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I do not have HIV/AIDS or any active, uncontrolled infections.
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I have been treated with specific inhibitors for cancer before.
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More than a quarter of my bone marrow has been exposed to radiation.
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I have brain metastases or spinal issues needing steroids to manage symptoms.
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My cancer has not spread to my brain or caused a severe crisis.
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I have a known bleeding disorder or brain hemorrhage.
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I have had a stem cell transplant after high-dose chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part C: ER+/HER2- BC Dose ExpansionExperimental Treatment1 Intervention
INX-315 in combination with CDK4/6i and endocrine therapy, oral administration
Group II: Part B: Ovarian Dose ExpansionExperimental Treatment1 Intervention
INX-315 monotherapy, oral administration
Group III: Part A: Dose EscalationExperimental Treatment1 Intervention
Multiple doses of INX-315 monotherapy, oral administration
Group IV: Part A INX-315 + FulvestrantExperimental Treatment2 Interventions
INX-315 dose plus Fulvestrant 500mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3510

Find a Location

Who is running the clinical trial?

Incyclix BioLead Sponsor

Media Library

INX-315 (CDK2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05735080 — Phase 1 & 2
CCNE1 Amplification Research Study Groups: Part C: ER+/HER2- BC Dose Expansion, Part A: Dose Escalation, Part B: Ovarian Dose Expansion, Part A INX-315 + Fulvestrant
CCNE1 Amplification Clinical Trial 2023: INX-315 Highlights & Side Effects. Trial Name: NCT05735080 — Phase 1 & 2
INX-315 (CDK2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05735080 — Phase 1 & 2
~34 spots leftby Dec 2025
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