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

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Incyclix Bio

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that you cannot take certain prohibited medications or herbal remedies that cannot be stopped at least 2 weeks before starting the study drug.

Eligibility Criteria

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.

Inclusion Criteria

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

I am fully active or can carry out light work.

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

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

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

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

Exclusion Criteria

My heart condition or high blood pressure is not well-managed, even with medication.

I have trouble swallowing or absorbing pills.

I have a heart condition that affects my heart's electrical activity.

I have not had intense radiotherapy in the last 28 days or any palliative radiotherapy in the last 2 weeks.

I am not planning to have any major surgery within 28 days of starting the study drug.

I do not have HIV/AIDS or any active, uncontrolled infections.

I have been treated with specific inhibitors for cancer before.

More than a quarter of my bone marrow has been exposed to radiation.

I have brain metastases or spinal issues needing steroids to manage symptoms.

My cancer has not spread to my brain or caused a severe crisis.

I have a known bleeding disorder or brain hemorrhage.

I have had a stem cell transplant after high-dose chemotherapy.

Participant Groups

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).

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