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Active Not Recruiting NCT04928508

Advanced or Recurrent Solid Tumors Treated With SHetA2

Conditions: Solid Tumor, Adult

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 50
Sponsor: University of Oklahoma

Location: Stephenson Cancer Center Oklahoma City Oklahoma

Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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. Patients must have adequate: * 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 Criteria: * 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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04928508). StuddyBuddy aggregates publicly available trial information.