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New treatment option for Solid Tumor, Adult
Official title Advanced or Recurrent Solid Tumors Treated With SHetA2
ClinicalTrials.gov ID: NCT04928508
What this study is testing
What is OK-1?
OK-1 is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for solid tumor, adult.
Also referred to as NSC 726189.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research is to test the safety of the study drug (OK-1) and see what effects (good and bad) this drug has on patients with recurrent solid tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients must have histologic diagnosis of recurrent solid tumor which has progressed through available therapies with expected survival benefit...
- 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...
You likely can't join if
- Unable to take oral medications
- Patients of childbearing potential not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not...
- Patients who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the trial, starting with the screening...
- 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...
- Patients receiving treatment for active autoimmune disease. "Active" refers to any condition currently requiring therapy. Examples of autoimmune...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 how well it works assessment of the investigational regimen are eligible for...
What rules you out
- 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...
- Patients with a prior or concurrent malignancy whose natural history or treatment does have the potential to interfere with the safety or how well it works assessment of the investigational regimen are NOT eligible for...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Oklahoma City, Oklahoma, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oklahoma City, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.