Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer

NCT03878849 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: (PARPi) 2X-10022020-000539-31
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Advanced Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate the optimal dose of 2X-121 as single agent therapy

  To evaluate the optimal dose of 2X-121 as single agent therapy at 600 mg daily compared to 800 mg daily.

  From enrollment up to approximately 2 years

Secondary Outcomes (5)

• Clinical benefit rate (CBR)

  From enrollment up to approximately 2 years

• Progression free survival

  From enrollment up to approximately 2 years

• Overall survival

  From enrollment up to approximately 2 years

• Evaluate disease control rate (DCR)

  At baseline and start of each cycle, up to approximately 2 years

• Evaluate objective response rate (ORR)

  From enrollment up to approximately 2 years

Study Arms (2)

Drug: 2X-121 600 mg

EXPERIMENTAL

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.

Drug: 2X-121

Drug: 2X-121 800 mg

EXPERIMENTAL

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.

Drug: 2X-121

Interventions

2X-121 DRUG

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.

Also known as: E7449, MGI25036

Drug: 2X-121 600 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent form.
• Age 18 years or older.
• Histologically or cytologically documented epithelial ovarian, fallopian tube, or primary peritoneal tumors, with high-grade serous or endometrioid, or predominantly serous/endometrioid histology (independent of BRCA1 and HRD status).
• Patients must have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible.
• Patients have received no more than one line of therapy in the platinum resistant or platinum ineligible setting. Note: Prior ADCs therapy (e.g., Elahere) will not count towards this previous line of therapy.
• Measurable disease by CT scan or MRI. Note: Baseline tumor assessment will be performed within 4 weeks prior to Day 1 Cycle 1
• 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 as evidenced by the following clinical laboratory values:
• Absolute neutrophils count (ANC) ≥ 1.5 x 103 μL
• Hemoglobin \> 9.0 g/dL
• Platelets ≥ 100 x 103 μL
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase ≤ 2.5 x ULN, unless liver metastases are present, in which case they must be ≤5 x ULN
• Serum bilirubin ≤ 1.5 ULN

You may not qualify if:

• Patients who have platinum-refractory disease, defined as progression during the last platinum-based chemotherapy.
• Concurrent chemotherapy, antibody therapies radiotherapy,hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period.
• Other malignancy with exception of any stage I and II cancer that is deemed cured by the Investigator.
• Any active infection requiring parenteral or oral antibiotic treatment.
• Known HIV positivity.
• Known active hepatitis B or C.
• Clinically significant cardiovascular disease:
• Stroke within ≤ 12 months prior to day 1
• Transient ischemic attach (TIA) within ≤ 12 months prior to day 1
• Myocardial infarction within ≤ 12 months prior to day 1
• Unstable angina
• New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF)
• Uncontrolled cardiac arrhythmia requiring medication
• Other medications or conditions that in the Investigator's opinion would contraindicate study participation for 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, diarrhea, or vomiting) that might impair the bioavailability of 2X-121.

Sponsors & Collaborators

• Allarity Therapeutics: lead
• Alcedis GmbH: collaborator
• Amarex Clinical Research: collaborator

Study Sites (2)

OU Health Stephenson Cancer

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Swedish Center for Research and Innovation

Seattle, Washington, 98122, United States

RECRUITING

MeSH Terms

Interventions

stenoparib

Central Study Contacts

Kush Dhody, MD, MS

CONTACT

+1-301-528-7000 ext. 716; kushd@amarexcro.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 18, 2019
• Study Start: April 15, 2019
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)