CLINICAL TRIALS PROFILE FOR TK-112690

Clinical Trials for TK-112690

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT04046250 ↗	Phase 2a Study to Evaluate Suppression of Methotrexate-induced Mucositis by TK112690	Completed	Crystal Life Sciences	Phase 2	Patients will receive methotrexate at a dose of 45 mg/m2 administered weekly for 4 consecutive weeks as an iv infusion along with a nutritional supplement administered two hours before the methotrexate. One hour before the methotrexate treatment the patients will be administered the first infusion of the day of either TK112690 or placebo depending on randomization. Five hours after the methotrexate treatment the patients will be administered the second treatment of either TK112690 or placebo depending on randomization. The TK112690 dose will be 45 mg/kg.
NCT04046250 ↗	Phase 2a Study to Evaluate Suppression of Methotrexate-induced Mucositis by TK112690	Completed	Tosk, Inc.	Phase 2	Patients will receive methotrexate at a dose of 45 mg/m2 administered weekly for 4 consecutive weeks as an iv infusion along with a nutritional supplement administered two hours before the methotrexate. One hour before the methotrexate treatment the patients will be administered the first infusion of the day of either TK112690 or placebo depending on randomization. Five hours after the methotrexate treatment the patients will be administered the second treatment of either TK112690 or placebo depending on randomization. The TK112690 dose will be 45 mg/kg.
NCT05658016 ↗	Phase 2a Study to Evaluate Suppression of Radiotherapy-induced Mucositis by TK112690	Recruiting	SIRO Clinpharm Private Limited	Phase 2	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.
NCT05658016 ↗	Phase 2a Study to Evaluate Suppression of Radiotherapy-induced Mucositis by TK112690	Recruiting	Tosk, Inc.	Phase 2	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.
NCT05669521 ↗	Phase 2a Study to Evaluate Suppression of 5-Fluorouracil -Induced Mucositis by TK112690	Recruiting	SIRO Clinpharm Pvt. Ltd.	Phase 2	Patients expected to receive a 500 mg/m2 of Leucovorin by iv & 500 mg/m2 of Fluorouracil (5FU) by iv bolus for their Colorectal Cancer. The patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization at 5 hours & 11 hours post 5-FU iv bolus. This treatment cycle will continue weekly for 6 weeks. The TK112690 dose will be 45 mg/kg.
NCT05669521 ↗	Phase 2a Study to Evaluate Suppression of 5-Fluorouracil -Induced Mucositis by TK112690	Recruiting	Tosk, Inc.	Phase 2	Patients expected to receive a 500 mg/m2 of Leucovorin by iv & 500 mg/m2 of Fluorouracil (5FU) by iv bolus for their Colorectal Cancer. The patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization at 5 hours & 11 hours post 5-FU iv bolus. This treatment cycle will continue weekly for 6 weeks. The TK112690 dose will be 45 mg/kg.

Clinical Trial Conditions for TK-112690

Condition Name

Condition Name for
Intervention	Trials
Mucositis	3

Condition MeSH

Condition MeSH for
Intervention	Trials
Mucositis	3

Clinical Trial Locations for TK-112690

Trials by Country

Trials by Country for
Location	Trials
India	10

Clinical Trial Progress for TK-112690

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 2	3

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Recruiting	2
Completed	1

Clinical Trial Sponsors for TK-112690

Sponsor Name

Sponsor Name for
Sponsor	Trials
Tosk, Inc.	3
SIRO Clinpharm Private Limited	1
SIRO Clinpharm Pvt. Ltd.	1

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	3
Other	3