NCT03878849 · Allarity Therapeutics
Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer
What this study is about
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,
View original scientific description
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.
Interventions
DRUG
2X-121
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
2X-121 will be administered daily as 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.
Primary outcome measures
Evaluate the optimal dose of 2X-121 as single agent therapy
Time frame: From enrollment up to approximately 2 years
To evaluate the optimal dose of 2X-121 as single agent therapy at 600 mg daily compared to 800 mg daily.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Signed informed consent form. 2. Age 18 years or older. 3. 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). 4. Patients must have platinum-resistant disease, defined as progression within 6 months after the last dose of platinum-based chemotherapy, or are platinum ineligible. 5. 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. 6. Measurable disease by CT scan or MRI. Note: Baseline tumor assessment will be performed within 4 weeks prior to Day 1 Cycle 1 7. Performance status of ECOG ≤ 1. 8. Patients must have a life expectancy of \>16 weeks. 9. Recovered to Grade 1 or less from prior surgery or acute toxicities of prior ra
Where
- Oklahoma City, Oklahoma
- Seattle, Washington
Collaborators
Alcedis GmbH, Amarex Clinical Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 28, 2025 · Source of record for eligibility and locations