Actively Recruiting
Advanced or Recurrent Solid Tumors Treated With SHetA2
Led by University of Oklahoma · Updated on 2026-03-05
50
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
Sponsors
U
University of Oklahoma
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Advanced or Recurrent Solid Tumors Treated With SHetA2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Histologic diagnosis of recurrent solid tumor that has progressed despite available therapies
- Adequate bone marrow, renal, and hepatic function as defined by the protocol
- International normalized ratio (INR) or prothrombin time (PT) ≤1.5 times upper limit of normal unless on anticoagulants with therapeutic range
- Activated partial thromboplastin time (aPTT) ≤1.5 times upper limit of normal unless on anticoagulants with therapeutic range
- Neuropathy (sensory and motor) grade 1 or less
- Free of active infection requiring IV antibiotics or serious uncontrolled medical illness within 4 weeks prior to entry
- Discontinued any hormone therapy directed at the tumor at least 1 week prior to registration; hormone replacement therapy allowed
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Negative pregnancy test prior to study entry and practicing effective contraception if of childbearing potential
- Willingness to discontinue breastfeeding prior to study entry
- Satisfactory baseline laboratory and diagnostic results per protocol
- Signed informed consent and authorization for release of health information
- Fresh pre-treatment tumor biopsy required for all cohorts except optional for dose levels 2 and 3; mandatory for cohort 4 and dose expansion
- Willing to have fresh biopsy after cycle 1 treatment if applicable
- Life expectancy of at least 3 months
- Ability to take oral medications
- Prior or concurrent malignancies allowed if not interfering with safety or efficacy assessment
You will not qualify if you...
- Unable to take oral medications
- Childbearing potential patients not using adequate contraception, pregnant, or breastfeeding
- Pregnancy, breastfeeding, or planning conception during study and 120 days after last dose
- History of allergic reaction to compounds similar to OK-1
- Diagnosis of immunodeficiency or receipt of systemic steroids or immunosuppressive therapy within 7 days before first dose
- Receiving treatment for active autoimmune disease requiring therapy (except stable low-dose steroids with medical monitor approval)
- Prior or concurrent malignancy interfering with safety or efficacy assessment
- Active hepatitis B or C infection, ongoing systemic bacterial, fungal, or viral infection
- Known HIV infection with positive viral load or AIDS-related illness (HIV with negative viral load allowed)
- Severe unrelated medical problems limiting compliance or increasing risk
- History or evidence of central nervous system disease such as primary brain tumor, uncontrolled seizures, recent stroke or brain metastases unless stable and off steroids
- Concomitant non-study chemotherapy or investigational therapies
- Participation in another investigational study within 4 weeks before first dose
- Recent chemotherapy within 4 weeks or radiation within 2 weeks prior to study start, or unresolved adverse events from prior treatments except grade ≤2 neuropathy or alopecia
- Prior bone marrow or stem cell transplantation
- History of solid organ, bone marrow, or progenitor cell transplantation
- Major surgery within 28 days before starting study treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
Research Team
I
Ingrid Block
CONTACT
L
Lead Gynecology Oncology Nurse
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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