Investigation of 2X-121 in Patients With Advanced Ovarian Cancer Selected by the 2X-121 DRP®

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study is to be performed as an open label, multicenter, single arm study of 2X-121 to evaluate anti-tumor efficacy of 2X-121 as single agent therapy in a 28-days cycle in advanced ovarian cancer patients. 2X-121 will be supplied for oral administration once daily as 600 mg (3 x 200 mg) capsules in a 28 days cycle. Patients with predicted high likelihood of responding to the drug (2X-121) using drug response prediction (DRP®), will be included in the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allarity Therapeutics; Oncology Venture
• Collaborators: Alcedis GmbH; Amarex Clinical Research

Criteria

Inclusion Criteria:

• Signed informed consent form

• Age 18 years or older

• Histologically or cytological documented ovarian carcinoma with ≥ 2 or more previous chemotherapies including potential treatment with other PARP inhibitors (PARPi)

• Platinum free interval of ≥ 3 month

• Measurable disease by CT scan or MRI

• A 2X-121 DRP® using Fixed in Formalin and Embedded in Paraffin (FFPE) archival or the latest tumor tissue with an outcome measured as being in the upper 50% likelihood of response

• Performance status of ECOG ≤ 1

• Patients must have a life expectancy of >16 weeks

• Recovered to Grade 1 or less from prior surgery or acute toxicities of prior radiotherapy, or treatment with cytotoxic, hormonal or biologic agents

• Adequate conditions and protocol values of the following clinical laboratory parameters:

1. Absolute neutrophils count

2. Hemoglobin

3. Platelets

4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)

5. Serum bilirubin

6. Alkaline phosphatase

7. Creatinine

8. Blood urea within normal limits

• FFPEs tumor tissue should be available either from primary surgery or later

• Negative serum pregnancy test in women of childbearing potential (WOCBP).

• Women of childbearing age and potential must be willing to use adequate effective contraception during the study and a period after last dose of study drug

Exclusion Criteria:

• Currently participating in or having participated in a study of an investigational agent or using an investigational device within 2 weeks of giving informed consent

• Concurrent chemotherapy, radiotherapy, or hormonal therapy for the disease under investigation

• Other malignancy with exception of any stage I and II cancer that is deemed cured or deemed not to influence the overall survival by the Investigator

• Any active infection still requiring parenteral or oral antibiotic treatment

• Known HIV positivity

• Known active hepatitis B or C

• Clinical significant (i.e. active) cardiovascular disease:

1. Stroke within ≤ 6 months prior to day 1

2. Transient ischemic attack (TIA) within ≤ 6 months prior to day 1

3. Myocardial infarction within ≤ 6 months prior to day 1

4. Unstable angina

5. New York Hart Association (NYHA) Grade II or greater congestive heart failure (CHF)

6. Serious cardiac arrhythmia requiring medication

• 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

• Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhoea, or vomiting) that might impair the bioavailability of 2X-121

• Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy

• 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)

• Subjects that are depending on the sponsor/CRO or investigational site as well as on the investigator