2X-121 for Ovarian Cancer

(PREDICT 2X-121 Trial)

Recruiting at 4 trial locations

Overseen By Kush Dhody, MD, MS

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Allarity Therapeutics

Must not be taking: Chemotherapy, Antibody therapies

Disqualifiers: Platinum-refractory, Active infection, HIV, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, 2X-121, to determine the optimal dose for treating advanced ovarian cancer unresponsive to platinum-based chemotherapy. The study compares two daily doses, 600 mg and 800 mg, to assess safety and effectiveness. It seeks patients with advanced ovarian cancer that worsened within six months after their last platinum treatment or who cannot take platinum drugs. Participants must have measurable cancer by scan and have undergone one prior treatment in this setting. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot take other chemotherapy, antibody therapies, or hormonal therapy during the study, except for non-disease related conditions like insulin for diabetes.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research has shown that 2X-121, also known as stenoparib, produced promising results in earlier studies for treating ovarian cancer. In these studies, patients with ovarian cancer unresponsive to standard treatments lived longer, with an average survival time of over 25 months. This suggests the drug has been somewhat effective without causing major issues for most patients.

The FDA granted 2X-121 a fast track designation, indicating it might offer significant benefits over current treatments and appears reasonably safe so far. However, this treatment remains under investigation, so risks and side effects may not be fully known yet. Participants should consult their doctor to weigh the potential benefits and risks before joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

Researchers are excited about 2X-121 for ovarian cancer because it offers a novel approach by targeting specific cancer cell vulnerabilities. Unlike the standard care treatments, which often involve a combination of surgery and chemotherapy, 2X-121 works by inhibiting DNA repair mechanisms in cancer cells, making them more susceptible to damage and death. This targeted action not only has the potential to be more effective but might also lead to fewer side effects compared to conventional therapies. Additionally, the flexible dosing options (600 mg and 800 mg) allow for personalized treatment plans, which could optimize outcomes for different patients.

What evidence suggests that 2X-121 might be an effective treatment for ovarian cancer?

Research has shown that 2X-121 yields promising results for patients with platinum-resistant ovarian cancer. In this trial, participants will receive either a 600 mg or 800 mg dose of 2X-121. Studies have found that patients treated with 2X-121 live for more than 25 months on average, indicating that many patients have lived longer than expected after receiving this treatment. The treatment targets cancer cells specifically, helping to slow the disease. These findings suggest it could benefit patients who haven't responded well to other treatments. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced ovarian cancer who've had at least two prior chemotherapy treatments and a platinum-free interval of ≥3 months. Participants must have measurable disease, an ECOG performance status ≤1, life expectancy >16 weeks, and meet specific lab criteria. They should respond well to the drug as predicted by a special test (2X-121 DRP®) and be able to take oral medication.

Inclusion Criteria

You have a medical condition that can be seen on a CT scan or MRI.

I have tumor tissue samples available from surgery.

You are expected to live for more than 16 weeks.

Exclusion Criteria

You have HIV.

Patients unable to be regularly followed for any reason (geographic, familiar, social, psychologic, housed in an institution eg. prison because of a court agreement or administrative order)

Other medications or conditions that in the investigator's opinion would contraindicate study participation of safety reasons or interfere with the interpretation of study results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2X-121 as single agent therapy at either 600 mg or 800 mg daily in 28-day cycles

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 2X-121

Trial Overview The study tests the effectiveness of an oral drug called 2X-121 in patients with advanced ovarian cancer. Patients will take this drug daily in cycles of 28 days. The trial uses a Drug Response Predictor (DRP®) to select patients likely to benefit from the treatment.

How Is the Trial Designed?

Group I: Drug: 2X-121 800 mg Experimental Treatment 1 Intervention

2X-121 will be administered 800 mg (400 mg (2 x 200 mg) 2X-121 morning dose + 400 mg (2 x 200 mg) 2X-121 evening dose) hard gelatin capsules in a 28 days cycle.

Group II: Drug: 2X-121 600 mg Experimental Treatment 1 Intervention

2X-121 will be administered daily as 600 mg (200 mg 2X-121 morning dose + 400 mg (2 x 200 mg) 2X-121 evening dose) hard gelatin capsules in a 28 days cycle.

Who Is Running the Clinical Trial?

Allarity Therapeutics

Lead Sponsor

Trials

8

Recruited

310+

Alcedis GmbH

Industry Sponsor

Trials

10

Recruited

670+

Amarex Clinical Research

Collaborator

Trials

28

Recruited

1,700+

Citations

1. allarity.com allarity.com/press-release/allarity-therapeutics-presents-new-phase-2-clinical-data-for-stenoparib-2x-121-showing-landmark-median-overall-survival-has-now-surpassed-25-months/

Allarity Therapeutics Presents New Phase 2 Clinical Data ... Allarity Therapeutics Presents New Phase 2 Clinical Data for Stenoparib/2X-121 Showing Landmark Median Overall Survival Has Now Surpassed 25 ...

2. onclive.com onclive.com/view/stenoparib-monotherapy-yields-potential-os-benefit-in-platinum-resistant-ovarian-cancer

Stenoparib Monotherapy Yields Potential OS Benefit in ... Stenoparib demonstrated extended overall survival in platinum-resistant ovarian cancer, with a median OS exceeding 25 months and not yet reached ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03878849

Investigation of the Anti-tumor Effect of 2X-121 in Patients ... The purpose of this study is to evaluate the optimal dose of 2X-121 as single agent therapy at 600 mg daily (split BID 200 mg morning + 400 mg evening)

4. finance.yahoo.com finance.yahoo.com/news/allarity-therapeutics-presents-phase-2-120000220.html

Allarity Therapeutics Presents New Phase 2 Clinical Data ... ... Survival exceeds 25 months for Platinum Resistant and Refractory Ovarian Cancer Patients receiving stenoparib/2X-121 twice daily. - Two ...

5. cancernetwork.com cancernetwork.com/view/stenoparib-receives-fda-fast-track-designation-in-advanced-ovarian-cancer

Stenoparib Receives FDA Fast Track Designation in ... Investigation of the anti-tumor effect of 2x-121 in patients with recurrent, advanced ovarian cancer. ClinicalTrials.gov. Updated May 8 ...

6. targetedonc.com targetedonc.com/view/dual-parp-tankyrase-inhibitor-shows-prolonged-os-in-ovarian-cancer

Dual PARP/Tankyrase Inhibitor Shows Prolonged OS in ... 1. Allarity Therapeutics Presents New Phase 2 Clinical Data for Stenoparib/2X-121 Showing Landmark Median Overall Survival Has Now Surpassed 25 ...

7. onclive.com onclive.com/view/fda-grants-fast-track-designation-to-stenoparib-for-advanced-ovarian-cancer

FDA Grants Fast Track Designation to Stenoparib for ... The FDA has granted fast track designation to stenoparib (formerly E7449; 2X-121), an investigational, orally available small-molecule ...