NCT05658016

Phase 2a Study to Evaluate Suppression of Radiotherapy-induced Mucositis by TK112690

A Phase 2a, Multi-center, Placebo-Controlled, Randomized, Assessor-blind Study to Assess the Safety & Efficacy of Parenteral TK-90 or Parenteral TK-90 Placebo to Patients Receiving Radiotherapy for Non-Metastatic Squamous Cell Carcinoma of Head and Neck.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Tosk, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients expected to receive a continuous course of radiation as single daily fractions of 2.0 Gy treatment with a cumulative radiation dose of 70 Gy. The radiation can be 2DRT, 3DRT,IMRT etc. Prior to each radiation treatment the patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization. 6 Hours after the completion of TK-90 infusion or TK-90 placebo dose, the patients will receive another identical TK-90 or TK-90 placebo treatment depending on randomization. This treatment cycle will continue for 7 weeks. The TK112690 dose will be 45 mg/kg.

Detailed description

Patients expected to receive a continuous course of radiation as single daily fractions of 2.0 Gy treatment with a cumulative radiation dose of 70 Gy. The radiation can be 2DRT, 3DRT,IMRT etc. Prior to each radiation treatment the patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization. 6 Hours after the completion of TK-90 infusion or TK-90 placebo dose, the patients will receive another identical TK-90 or TK-90 placebo treatment depending on randomization. This treatment cycle will continue for 7 weeks. The TK112690 dose will be 45 mg/kg. * 24 patients will be randomized equally into 2 different groups: TK-90 treated or TK-90 placebo treated. * Screening must be completed within 2 weeks. * The treatment period for the study is 7 weeks. * Study follow-up will be scheduled post two weeks of completion of last dose of radiation or early termination through up to 4 weeks. * Blinding: The study will be partially blinded. The patient and investigator as well as site personnel will be blinded as to whether TK-90 or TK-90 placebo is administered. The CRO, sponsor, and site pharmacist will know whether the patient was administered active drug or TK-90 placebo.

Conditions

• Mucositis

Interventions

Type	Name	Description
DRUG	TK-112690	TK112690 treatment Pre \& Post Radiation
DRUG	Placebo	TK112690 Placebo treatment Pre \& Post Radiation

Timeline

• Start date: 2022-06-17
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2022-12-20
• Last updated: 2023-08-14

Locations

5 sites across 1 country: India

Regulatory

• FDA-regulated drug study