AzTrials
AzTrials

Solid Tumor, AdultPhase 1Okgyn1NCT04928508

Advanced or Recurrent Solid Tumors Treated With SHetA2

A Phase 1 study testing OK-1 in people with Solid Tumor, Adult, run by University of Oklahoma at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Solid Tumor, Adult
What is being tested?
OK-1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
27 Jul 2022to Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 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
Show all 19Show fewer
  • 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.

Who cannot join

  • 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)
Show all 19Show fewer
  • 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.
  • NOTE: Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging (using the identical imaging modality for each assessment, either magnetic resonance imaging [MRI] or computed tomography [CT] scan) for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. Carcinomatous meningitis precludes a patient from study participation regardless of clinical stability
  • 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.
  • Note: Patients with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study.
  • Note: If the patient underwent major surgery, she must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Official title: Phase 1 Trial of OK-1 (SHetA2) in Patients With Advanced or Recurrent Solid Tumors

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.

Read the detailed description

OK-1 capsules will be given twice a day, every day in 21-day blocks of time. Each block of time is called a cycle. The cycle will be repeated until the patient or doctor no longer feel participation in the study is right for the patient. There will be lab tests and examinations to monitor the patients progress. We expect that taking part in this research will last up to three years.

Being tested
OK-1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OK-1Drug

    Also called NSC 726189

    OK-1 orally in the form of 50 mg capsules. Four dose levels will be evaluated:

    5.4mg/kg 7.0mg/kg 9.0mg/kg 12mg/kg

Study groups in NCT04928508
Study groupRoleWhat they receive
OK-1 capsuleExperimentalOK-1 (oral, BID) within a 21-days cycle
Receives: Drug: OK-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of dose-limiting toxicities of treatment with OK-1

    Measured: 21 days

  2. Dosage Recommendation for Phase 2

    Measured: 21 days

Secondary outcomes (10)

  1. Rate of objective response

    Measured: up to three years

  2. Median duration of response

    Measured: up to three years

  3. Rate of disease control

    Measured: up to three years

  4. Median progression free survival

    Measured: up to three years

  5. Median overall survival

    Measured: up to three years

  6. Incidence of adverse events

    safety and tolerability of OK-1 using Common Terminology Criteria for Adverse Events (CTCAE) v.5.0

    Measured: up to three years

  7. Tmax of PK plasma concentration

    Measured: 24 hours

  8. Cmax of PK plasma concentration

    Measured: 24 hours

  9. AUC of PK plasma concentration

    Measured: 24 hours

  10. t1/2 of PK plasma concentration

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2021
  2. Study start27 Jul 2022
  3. Primary completionSep 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04928508
Sponsor's protocol ID
OU-SCC-OKGyn1
Other IDs
R01CA196200
Acronym
Okgyn1
Status last verified
Aug 2026
First submitted
10 Jun 2021
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mortan LF, Isingizwe ZR, Benbrook DM. Identification and Experimental Validation of Triosephosphate Isomerase 1 as a Functional Biomarker of SHetA2 Sensitivity in Ovarian Cancer. Cells. 2026 Jan 30;15(3):267. doi: 10.3390/cells15030267.

    PubMed 41677630

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OK-1 in people with Solid Tumor, Adult, run by University of Oklahoma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of dose-limiting toxicities of treatment with OK-1 (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04928508, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in