2X-121 for Ovarian Cancer

(PREDICT 2X-121 Trial)

Recruiting at 4 trial locations

Overseen By Europe: Rebecca Kristeleit

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

Trial Summary

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.

What is the purpose of this trial?

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) compared to 800 mg daily (split BID 400 mg morning + 400 mg evening) in recurrent, advanced ovarian cancer patients that have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible. The optimal dose will be selected based on an integrated analysis of PK/PD, safety, and efficacy data.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+