INX-315 for Advanced Cancer

(INX-315-01 Trial)

Recruiting at 9 trial locations

Overseen By Clinical Director

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Incyclix Bio

Must not be taking: Corticosteroids, Herbal remedies

Disqualifiers: CNS metastases, ILD, Cardiovascular disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

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.

Exclusion Criteria

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

I have had cancer before, but it was treated successfully.

I have trouble swallowing or absorbing pills.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part A involves dose escalation to evaluate the safety, tolerability, and PK of INX-315 monotherapy, including a 28-day DLT assessment period

28 days

Multiple visits for dose escalation and monitoring

Dose Expansion

Part B involves dose expansion for ovarian cancer patients with CCNE1 amplifications, evaluating at least two dose levels

Varies based on dose level

Regular visits for treatment and monitoring

Combination Treatment

Part C involves combination treatment of INX-315 with CDK4/6i and endocrine therapy in ER+/HER2- breast cancer patients

Varies based on treatment response

Regular visits for combination treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• INX-315

Trial Overview 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).

Participant Groups

Group I: Part C: HR+/HER2- BC Dose Expansion Experimental Treatment 3 Interventions

INX-315 in combination with abemaciclib (oral administration) and fulvestrant (IM)

Group II: Part B: Ovarian Dose Expansion Experimental Treatment 1 Intervention

INX-315 monotherapy, oral administration

Group III: Part A: Dose Escalation Experimental Treatment 1 Intervention

Multiple doses of INX-315 monotherapy, oral administration

Group IV: Part A INX-315 + Fulvestrant Experimental Treatment 2 Interventions

INX-315 dose plus Fulvestrant 500mg (IM)

Who Is Running the Clinical Trial?

Incyclix Bio

Lead Sponsor

Trials

1

Recruited

90+