NCT04928508

Advanced or Recurrent Solid Tumors Treated With SHetA2

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	OK-1	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

Timeline

• Start date: 2022-07-27
• Primary completion: 2026-05-01
• Completion: 2027-06-01
• First posted: 2021-06-16
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study