NCT04739293

Study of ON 123300 in Patients With Advanced Cancer

Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of ON 123300 Capsules Administered Orally as Escalating Daily Doses in Patients With Advanced Cancer Relapsed or Refractory to at Least One (1) Prior Line of Therapy

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Traws Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the safety of the drug ON 123300 at increasing doses to determine the best dose to use in future clinical trials.

Detailed description

After being informed about the study including potential risks, patients giving written informed consent will proceed to a screening period when assessments will be performed to determine whether the patient is eligible to participate in the study. If the patient is eligible, they will start to receive ON 123300 as capsules every day. On day 1 and Day 8 of the study, patients will be required to provide eight blood samples to allow measurement of the amount of drug in their blood. Three ECGs will also be performed during this time. Patients will continue to receive ON 123300 until disease progression, unacceptable toxicity, or patient or physician decision to stop. The first group of patients will receive 40mg of ON 123300 daily, the next group 80mg of ON 123300, the 120mg, etc. until the correct dose has been determined for future studies. Patients will visit the clinic on Days 1, 2, 8, and 9, then weekly for the first month, then every two weeks for two more months, then every month.

Conditions

• Solid Tumors, Adult

Interventions

Type	Name	Description
DRUG	ON123300	ON 123300 hard gelatin capsules

Timeline

• Start date: 2021-05-13
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2021-02-04
• Last updated: 2023-12-07

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study