Study of OK-1 for Advanced or Recurrent Solid Tumors
This study is testing a drug called OK-1 in people with advanced or recurrent (returned) solid tumors. The main goal is to find out how safe OK-1 is and what side effects it might have. Researchers will also look at the good effects of the drug. You might be able to join if you are an adult with a solid tumor that has progressed after other treatments, and you have good organ function. The study aims to find the best dose of OK-1 for future research. This study is currently unclear about its recruitment status and plans to enroll 50 participants.
- Study design
- This is an interventional study with an unclear phase, planning to enroll 50 adult participants. It will evaluate different doses of OK-1.
- What's involved
- You would take OK-1 capsules twice a day in 21-day cycles, which will repeat until you or your doctor decide to stop. You will have lab tests and examinations to monitor your progress, and participation is expected to last up to three years.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for safety and dosage recommendation are measured at 21 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04928508
Advanced or Recurrent Solid Tumors Treated With SHetA2
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of OklahomaInvestigator-initiated
~50 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:OK-1
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of dose-limiting toxicities of treatment with OK-1
Measured over 21 days
+1 more outcome measured
Conditions
NCT04928508
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Stephenson Cancer Center
Oklahoma City, Oklahomano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Debra Richardson, MD · PRINCIPAL_INVESTIGATOR · Stephenson Cancer Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Eligibility criteria
Inclusion
Patients must have histologic diagnosis of recurrent solid tumor which has progressed through available therapies with expected survival benefit. Histologic documentation of the original primary tumor is required via the pathology report.
Bone marrow function as defined per protocol
Renal function as defined per protocol
Hepatic function as defined per protocol
International normalized ratio (INR) or prothrombin time (PT) ≤1.5x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Activated partial thromboplastin time (aPTT) ≤1.5x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1. Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.
Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
Patients must have a performance status score of 0-2 by Eastern Cooperative Group (ECOG) criteria.
Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.
Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol
Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.
Patients must be at least 18 years old.
Patients in all cohorts must have a fresh pre-treatment tumor biopsy. This is optional only for patients enrolled on dose level 2 and 3. Biopsies are mandatory on cohort 4 and/or expansion.
Patients must be willing to have fresh biopsy taken post-Cycle 1 treatment (optional only for patients enrolled on dose level 2 and 3; Biopsies are mandatory for patients enrolling on Cohort 4 and/or dose expansion phase.)
Life expectancy of at least 3 months.
Patients must be able to take oral medications.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Exclusion
Unable to take oral medications
Patients of childbearing potential not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial
Patients who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to OK-1.
A diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Patients receiving treatment for active autoimmune disease. "Active" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis. (note if steroid use is \<10mg/day prednisolone equivalent and patient has stable symptoms they may be allowed on study with discussion with the medical monitor)
Patients with a prior or concurrent malignancy whose natural history or treatment does have the potential to interfere with the safety or efficacy assessment of the investigational regimen are NOT eligible for this trial.
Known active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid \[HCV RNA\] \[qualitative\] is detected). Ongoing systemic bacterial, fungal, or viral infection; known human immunodeficiency virus (HIV) infection with positive viral load or acquired immunodeficiency syndrome (AIDS)-related illness. Patients with HIV and a negative viral load are allowed on study.
Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.
Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.
Patients taking concomitant therapy with any of the following: other non-study cytotoxic chemotherapy; other investigational therapies.
Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
Prior chemotherapy or targeted small molecule therapy within 4 weeks, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
Prior bone marrow/hematopoietic stem cell transplantation
History of solid organ, bone marrow, or progenitor cell transplantation
History of major surgical procedure within 28 days prior to start of study treatment
What this trial measures
- Number of dose-limiting toxicities of treatment with OK-121 days
- Dosage Recommendation for Phase 221 days