Actively Recruiting
Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer
Led by Allarity Therapeutics · Updated on 2025-08-28
40
Participants Needed
2
Research Sites
437 weeks
Total Duration
On this page
Sponsors
A
Allarity Therapeutics
Lead Sponsor
A
Alcedis GmbH
Collaborating Sponsor
AI-Summary
What this Trial 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, safety, and efficacy data.
CONDITIONS
Official Title
Investigation of the Anti-tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Age 18 years or older.
- Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal tumors with high-grade serous or endometrioid histology.
- Platinum-resistant disease, defined as progression within 6 months after last platinum chemotherapy, or platinum ineligible.
- No more than one prior therapy line in the platinum resistant or platinum ineligible setting.
- Measurable disease by CT scan or MRI within 4 weeks prior to treatment.
- ECOG performance status of 0 or 1.
- Life expectancy greater than 16 weeks.
- Recovery to Grade 1 or less from previous surgery or treatments.
- Adequate blood counts and liver, kidney function within defined limits.
- Availability of tumor tissue from current relapse or recent biopsy.
- Negative pregnancy test for women of childbearing potential.
- Use of effective contraception during the study and for at least six months after.
You will not qualify if you...
- Platinum-refractory disease with progression during last platinum chemotherapy.
- Receiving concurrent chemotherapy, antibody therapies, radiotherapy, hormonal therapy, or investigational drugs unrelated to study.
- Other active cancers except cured stage I or II cancers.
- Active infections requiring antibiotic treatment.
- Known HIV infection.
- Active hepatitis B or C infection.
- Significant cardiovascular disease within last 12 months including stroke, TIA, myocardial infarction, unstable angina, heart failure, or uncontrolled arrhythmia.
- Medical conditions or medications that contraindicate participation or affect study results.
- Inability to take oral medication or gastrointestinal conditions impairing drug absorption.
- Need for immediate palliative surgery or radiotherapy.
- Inability to attend regular follow-up visits.
- Close association with study investigators or sponsors.
- Ascites requiring drainage greater than 500cc in last 2 weeks.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
OU Health Stephenson Cancer
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
2
Swedish Center for Research and Innovation
Seattle, Washington, United States, 98122
Actively Recruiting
Research Team
K
Kush Dhody, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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