INX-315 for Advanced Cancer

(INX-315-01 Trial)

Recruiting at 16 trial locations

Overseen By Antonio Giordano, MD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, INX-315, for individuals with advanced or hard-to-treat cancers. The goal is to determine the safety and effectiveness of INX-315, particularly for breast cancer that no longer responds to other treatments and certain ovarian cancers. The study will evaluate how well INX-315 works alone or in combination with other cancer drugs. It may suit those whose breast cancer has progressed after treatment with CDK4/6 inhibitors or who have ovarian cancer unresponsive to standard therapies. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that INX-315, a new drug designed to inhibit proteins that promote cancer cell growth, is undergoing safety testing in people. In studies with patients who have advanced breast or ovarian cancer, some have responded positively to the treatment, indicating the drug's potential effectiveness against their cancer.

The ongoing research focuses on assessing how well patients tolerate this drug. As this is an early-stage trial, researchers continue to gather information on side effects and overall safety. The fact that INX-315 is already in human trials suggests that earlier research has demonstrated some level of safety. Participants should discuss any concerns with their healthcare provider and understand the potential risks and benefits before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about INX-315 for advanced cancer because it offers a fresh approach to treatment with its unique mechanism and combination potential. Unlike traditional chemotherapy, which broadly targets fast-growing cells, INX-315 works specifically by inhibiting pathways crucial for cancer cell survival, potentially leading to fewer side effects. In the trial, INX-315 is explored both as a standalone treatment and in combination with fulvestrant and abemaciclib, aiming to enhance the effectiveness against specific cancer types like ovarian and HR+/HER2- breast cancer. This combination approach is particularly promising as it may improve outcomes by attacking cancer cells from multiple angles simultaneously.

What evidence suggests that this trial's treatments could be effective for advanced cancer?

Studies have shown that INX-315, an oral medication, can stop cancer cells from growing by halting their division and causing them to age without dividing. Initial findings suggest that INX-315 is effective against certain tough-to-treat breast and ovarian cancers. In this trial, some participants will receive INX-315 alone, while others will receive it with fulvestrant. This combination may work well for hormone-sensitive breast cancers that haven't responded to other treatments. Additionally, research indicates that using INX-315 with both abemaciclib and fulvestrant might help in cases where breast cancer doesn't respond to other similar drugs. The FDA has granted INX-315 fast track status, recognizing its potential to treat difficult ovarian cancer cases. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05735080

NCT05735080 | Open-Label Study to Evaluate the Safety, ... This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of INX-315 in patients ...

2. onclive.com onclive.com/view/fda-grants-fast-track-designation-to-inx-315-in-ccne1-amplified-platinum-resistant-ovarian-cancer

FDA Grants Fast Track Designation to INX-315 in CCNE1- ... INX-315 has received FDA fast track designation for the treatment of patients with CCNE1-amplified, platinum-resistant or refractory ovarian ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10905675/

INX-315, a Selective CDK2 Inhibitor, Induces Cell Cycle ... The CDK2 inhibitor INX-315 induces cell cycle arrest and therapy-induced senescence, thereby controlling the growth of CCNE1-amplified cancers and CDK4/6 ...

4. oncnursingnews.com oncnursingnews.com/view/inx-315-receives-fda-fast-track-status-for-ccne1-amplified-ovarian-cancer

INX-315 Receives FDA Fast Track Status for CCNE1 ... The selective CDK2 inhibitor INX-315 has been given FDA fast track designation for use in CCNE1-amplified, platinum-resistant ovarian cancer.

5. targetedonc.com targetedonc.com/view/fda-fast-tracks-inx315-in-ovarian-cancer

FDA Fast-Tracks INX-315 in Ovarian Cancer The FDA granted fast track status to INX-315 for the potential treatment of CCNE1-amplified, platinum-resistant/refractory ovarian cancer.

6. clin.larvol.com clin.larvol.com/trial-detail/NCT05735080

Open-Label Study to Evaluate the Safety, Tolerability, PK ... INX-315 is a novel, potent and selective CDK2 inhibitor that is being evaluated in INX-315-01, an ongoing first-in-human Phase 1/2 clinical trial.

7. incyclixbio.com incyclixbio.com/wp-content/uploads/2023/04/AACR-2023.pdf

INX-315, a potent and selective CDK2 inhibitor, ... HR+ breast cancer cells (not resistant to CDK4/6i) were treated with a CDK4/6i. (palbociclib or abemaciclib) and/or INX-315 for up to 8 weeks and monitored for ...

8. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)00139-X/fulltext

Abemaciclib plus a nonsteroidal aromatase inhibitor as ... Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2− advanced breast cancer: final overall survival results of MONARCH 3☆