← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

INX-315-01 Trial Summary

This trial is testing a drug that could treat human cancers by blocking a certain protein. It will evaluate safety, effectiveness, and other factors.

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.Check my eligibility

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).See study design

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.

INX-315-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My ovarian cancer is resistant to platinum-based treatments and has worsened after standard treatment.

Select...

I am fully active or can carry out light work.

Select...

I have a tumor that can be measured and hasn't been treated with radiation.

Select...

My ER+/HER2- breast cancer has worsened after CDK4/6 inhibitor treatment.

Select...

My cancer has worsened after standard treatment or I cannot receive standard treatment.

Select...

My organ functions are within normal ranges according to recent tests.

INX-315-01 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A and B: Evaluate the incidents of treatment emergent adverse events and laboratory abnormalities

Part A: Evaluate the occurrence of dose-limiting toxicities (DLTs) during Cycle 1

Part A: Recommend at least two doses of INX-315 to be evaluated in the expansion phase

+2 more

Secondary outcome measures

Part A and B: Characterize the Area under the plasma concentration versus time curve from time 0 to the end of the dosing interval (AUC0-24h)

Part A and B: Characterize the maximum plasma concentration (Cmax)

Part A and B: Characterize the oral clearance (CL/F)

+8 more

INX-315-01 Trial Design

3Treatment 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

0 / 6Eligibility criteria met

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

Ovarian Cancer Research Study Groups: Part C: ER+/HER2- BC Dose Expansion, Part A: Dose Escalation, Part B: Ovarian Dose Expansion

Ovarian Cancer 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity to join this clinical research at the current moment?

"Affirmative. According to the clinicaltrials.gov portal, this medical trial is presently enrolling 81 individuals from a single site. The initial post for this study was created on March 28th 2023 and it has since been updated with new information that same day."

Answered by AI

Could you tell me the aggregate number of individuals involved in this trial?

"Indeed, data hosted on clinicaltrials.gov verifies that this medical research is currently enlisting volunteers. The study was initially listed in the public domain on March 28th 2023 and has since been updated once more to reflect its current recruitment status. As of now, 81 participants will be accepted at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05735080.

All > Breast Cancer Columbia