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Advanced Ovarian CancerPhase 2NCT03878849

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

A Phase 2 study testing 2X-121 in people with Advanced Ovarian Cancer, run by Allarity Therapeutics at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Ovarian Cancer
What is being tested?
2X-121
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
15 Apr 2019to Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Creatinine ≤ 1.5 ULN
  • Blood urea nitrogen (BUN) ≤2X ULN.
  • FFPE tumor tissue should be available from the current relapse, if obtainable, otherwise the most recent archival tumor tissue. Note: Patients treated with a PARP inhibitor must have a new biopsy unless there is an archival biopsy that was done after the PARP inhibitor treatment was discontinued.
  • Negative serum pregnancy test in women of childbearing potential (WOCBP). WOCBP is defined as premenopausal women or less than 12 months of amenorrhea post-menopause, and women who have not undergone surgical sterilization or hysterectomy or bilateral salpingo-oophorectomy.
  • Sexually active females of childbearing potential must use adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception) for the study duration and at least six months afterwards.

Who cannot join

  • 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.
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  • 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.
  • Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy.
  • Patients unable to be regularly followed for any reason (geographic, familiar, social, psychological, housed in an institution e.g., prison because of a court agreement or administrative order).
  • Patients, who are close colleagues, associates, or family members of, or in any way dependent on the sponsor or the investigator.
  • Ascites requiring drainage >500cc in the 2 weeks prior to enrolment.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kush Dhody, MD, MS contact

+1-301-528-7000 ext. 716

kushd@amarexcro.com

United States2 sites, 2 recruiting

  • OU Health Stephenson Cancer

    Oklahoma City, Oklahoma, 73104

    Christine Pappaterra, 405-271-8707, Christine-Pappaterra@ouhsc.edu

    Kathleen Moore, MD

    Recruiting

  • Swedish Center for Research and Innovation

    Seattle, Washington, 98122

    Karina Sills, 1.206.386.2227, karina.sills@swedish.org

    Fernanda Baptista Musa, MD

    Recruiting

Other trials in United States

About this study

Official title: Phase 2, Randomized, Prospective, Open-Label, Parallel-Arm, Dose Optimization Study to Investigate the Safety, Tolerability, PK/PD, and Anti- Tumor Effect of 2X-121 in Patients With Recurrent, Advanced Ovarian Cancer.

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.

Being tested
2X-121

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2X-121Drug

    Also called E7449, MGI25036

    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.

  • 2X-121Drug

    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.

Study groups in NCT03878849
Study groupRoleWhat they receive
Drug: 2X-121 600 mgExperimental2X-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.
Receives: Drug: 2X-121
Drug: 2X-121 800 mgExperimental2X-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.
Receives: Drug: 2X-121

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment up to approximately 2 years

Secondary outcomes (5)

  1. Clinical benefit rate (CBR)

    Measured: From enrollment up to approximately 2 years

  2. Progression free survival

    Measured: From enrollment up to approximately 2 years

  3. Overall survival

    Measured: From enrollment up to approximately 2 years

  4. Evaluate disease control rate (DCR)

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

  5. Evaluate objective response rate (ORR)

    Measured: From enrollment up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2019
  2. Study start15 Apr 2019
  3. Primary completionMar 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03878849
Sponsor's protocol ID
(PARPi) 2X-1002
Other IDs
2020-000539-31
Status last verified
Aug 2025
First submitted
8 Mar 2019
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 2X-121 in people with Advanced Ovarian Cancer, run by Allarity Therapeutics at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kush Dhody, MD, MS (+1-301-528-7000 ext. 716, kushd@amarexcro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the optimal dose of 2X-121 as single agent therapy (time frame: From enrollment up to approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03878849.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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