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Experimental cancer combo tested in tiny, terminated trial

NCT ID NCT05571969

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tested a new drug called 2X-121, alone and combined with another drug called dovitinib, in 14 people with advanced solid tumors. The goal was to find the safest dose and check for side effects. The study was terminated early, so results are limited and no conclusions about effectiveness can be drawn.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
2X-121 (a PARP inhibitor) and dovitinib (a targeted cancer drug)
What this could lead to
If successful, this could point toward a new combination treatment for advanced solid tumors that have stopped responding to other therapies.
What could go wrong
This was a very early (Phase 1) safety study that was terminated early with only 14 participants. The drugs may cause significant side effects, and it is unknown if they will shrink tumors or improve survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

14 people

The number who actually took part.

Started

Mar 2023

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18 years or older. 2. Histologically or cytological documented solid tumor. 3. Available tumor biopsy (most recent) for DRP® analysis. 4. Measurable disease by CT scan or MRI if possible. 5. Performance status of ECOG ≤ 1. 6. Recovered to Grade \<1 or baseline from prior surgery or from acute toxicities of prior radiotherapy, or from treatment with cytotoxic, hormonal or biologic agents. 7. ≥ 2 weeks must have elapsed since any prior surgery or therapy with G-CSF and GM-CSF. 8. Patients with intracranial disease must be on stable or decreased level of steroid therapy (e.g. dexamethasone) for at least 7 days prior to baseline MRI. Non-enzymatic inducing anti-epileptic drugs are allowed. 9. Adequate conditions as evidenced by the following clinical laboratory values: 1. Absolute neutrophils count (ANC) ≥ 1500/mm3 (1.5 x 10³/mL) 2. Hemoglobin \> 10.0 g/dL 3. Platelets ≥ 100,000/mm3 (≥ 100 x 10⁹/L) 4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN or ≤5x ULN in presence of liver metastases 5. Serum bilirubin ≤ 1.5 ULN 6. Alkaline phosphatase ≤ 2.5 x ULN 7. Creatinine ≤ 1.5 ULN 8. Blood urea nitrogen (BUN) ≤2X ULN. 10. Life expectancy equal or longer than 3 months. 11. The subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided and has had the opportunity to discuss the study with the investigator or designee. 12. The subject is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study. 13. The subject is able to understand the nature of the study and any potential hazards associated with participating in it. 14. Negative pregnancy test for female subjects of childbearing potential. Women of childbearing potential (WOCBP) and Women of non-childbearing potential are eligible to participate. Both women of childbearing potential and women of non-childbearing potential should use an approved method of birth control and agree to continue to use this method for the duration of the study (and for 90 days after taking the last dose of study drug). Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, implanted, or injected) in conjunction with a barrier method (WOCBP only) (e.g., diaphragm, cervical cap, male condom, and female condom and spermicidal foam, sponges, and film), female subject/partner's use of an intrauterine device (IUD), or if the female subject/partner is surgically sterile for at least three months before screening or 2 years post-menopausal at time of screening. All male subjects/partners must agree to consistently and correctly use a condom for the duration of the study and for 90 days after taking the study drug. In addition, subjects may not donate sperm for the duration of the study and for 90 days after taking study drug. \- Exclusion Criteria: 1. Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period. 2. Other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study. 3. Any active infection requiring parenteral or oral antibiotic treatment. 4. History of coagulation or bleeding disorder or subject currently on therapeutic anticoagulant medication. Note: Prophylactic doses of heparin or low molecular weight heparin are allowed. 5. Known HIV positivity. 6. Known active hepatitis B or C. 7. Clinically 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 Heart Association (NYHA) Class II or greater congestive heart failure (CHF) 6. Serious cardiac arrhythmia requiring medication. 8. Other medications or conditions, including surgery, that in the Investigator's opinion would contraindicate study participation for safety reasons or interfere with the interpretation of study results. 9. 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 and dovitinib. 10. Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy. 11. Female patients who are pregnant or breast-feeding (pregnancy test with a positive result before study entry). \-

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Carolina BioOncology

    Huntersville, North Carolina, 28078, United States

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

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