Trial Outcomes & Findings for Phase 2a Study to Evaluate Suppression of Methotrexate-induced Mucositis by TK112690 (NCT NCT04046250)

Results Overview

Mucositis Evaluation Using Established Scoring Systems: NCI/CTCAE at 4 WKs (Primary) and WHO at 4 WKs (Primary). NCI/CTCAE=National Cancer Institute/Common Terminology Criteria for Adverse Events and WHO=World Health Organization NCI Grades- 0= No mucositis, 1=Mild mucositis (Painless ulcers, erythema, or mild soreness in the absence of lesions), 2=Moderate mucositis (Painful erythema, edema, or ulcers but eating or swallowing possible), 3= Severe mucositis (Painful erythema, edema, or ulcers requiring IV hydration), 4=Life threatening, 5=Death WHO Grades- 0=No mucositis, 1= Mild (Oral soreness, erythema), 2=Moderate (Oral erythema, ulcers, solid diet tolerated), 3=Severe (Oral ulcers, liquid diet only), 4=Life-threatening (Oral alimentation impossible). For both the scales above, a higher score implies greater mucositis. Scale specific mean values for patients in each group (placebo or treated) are calculated and compared by Student's t-test.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

up to 4 Weeks

Results posted on

2023-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	TK112690 TK112690 treatment TK-112690: TK112690 treatment pre-methotrexate treatment	Placebo TK112690 formulation Placebo TK-112690: Placebo
Overall Study STARTED	11	11
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	TK112690 TK112690 treatment TK-112690: TK112690 treatment pre-methotrexate treatment	Placebo TK112690 formulation Placebo TK-112690: Placebo
Overall Study Death	0	1
Overall Study Withdrawal by Subject	3	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TK112690 n=11 Participants TK112690 treatment TK-112690: TK112690 treatment pre-methotrexate treatment	Placebo n=11 Participants TK112690 formulation Placebo TK-112690: Placebo	Total n=22 Participants Total of all reporting groups
Age, Continuous	54 years STANDARD_DEVIATION 11 • n=5 Participants	49 years STANDARD_DEVIATION 13 • n=7 Participants	52 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment India	11 participants n=5 Participants	11 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 4 Weeks

Population: Patients with SCCHN who have failed at least one prior treatment of chemotherapy and/or radiation

Mucositis Evaluation Using Established Scoring Systems: NCI/CTCAE at 4 WKs (Primary) and WHO at 4 WKs (Primary). NCI/CTCAE=National Cancer Institute/Common Terminology Criteria for Adverse Events and WHO=World Health Organization NCI Grades- 0= No mucositis, 1=Mild mucositis (Painless ulcers, erythema, or mild soreness in the absence of lesions), 2=Moderate mucositis (Painful erythema, edema, or ulcers but eating or swallowing possible), 3= Severe mucositis (Painful erythema, edema, or ulcers requiring IV hydration), 4=Life threatening, 5=Death WHO Grades- 0=No mucositis, 1= Mild (Oral soreness, erythema), 2=Moderate (Oral erythema, ulcers, solid diet tolerated), 3=Severe (Oral ulcers, liquid diet only), 4=Life-threatening (Oral alimentation impossible). For both the scales above, a higher score implies greater mucositis. Scale specific mean values for patients in each group (placebo or treated) are calculated and compared by Student's t-test.

Outcome measures

Outcome measures
Measure	TK112690 n=11 Participants TK112690 treatment TK-112690: TK112690 treatment pre-methotrexate treatment	Placebo n=11 Participants TK112690 formulation Placebo TK-112690: Placebo
Mucositis NCI/CTCAE at 4 WKs	0.37 score on a scale Standard Deviation 0.19	2.84 score on a scale Standard Deviation 0.29
Mucositis WHO at 4 WKs	0.34 score on a scale Standard Deviation 0.17	2.87 score on a scale Standard Deviation 0.31

SECONDARY outcome

Timeframe: Measured Weekly Over 4 Weeks of Study

Tolerance

Outcome measures

Outcome measures
Measure	TK112690 n=11 Participants TK112690 treatment TK-112690: TK112690 treatment pre-methotrexate treatment	Placebo n=11 Participants TK112690 formulation Placebo TK-112690: Placebo
Incidence Adverse Events That Are Related to Treatment SAEs	0 Participants	2 Participants
Incidence Adverse Events That Are Related to Treatment Deaths	0 Participants	1 Participants
Incidence Adverse Events That Are Related to Treatment TEAE GI and Related	1 Participants	11 Participants

Adverse Events

TK112690

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	TK112690 n=11 participants at risk TK112690 treatment TK-112690: TK112690 treatment pre-methotrexate treatment	Placebo n=11 participants at risk TK112690 formulation Placebo TK-112690: Placebo
Blood and lymphatic system disorders Neutropenia	0.00% 0/11 • 6 Weeks	18.2% 2/11 • Number of events 2 • 6 Weeks

Other adverse events

Other adverse events
Measure	TK112690 n=11 participants at risk TK112690 treatment TK-112690: TK112690 treatment pre-methotrexate treatment	Placebo n=11 participants at risk TK112690 formulation Placebo TK-112690: Placebo
Gastrointestinal disorders GI Disorders	9.1% 1/11 • 6 Weeks	63.6% 7/11 • 6 Weeks

Additional Information

Emile Youssef, MD, PhD

Tosk, Inc.

Phone: 312.244.0068

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Each of the three clinical sites has a PI. Each PI is bound by a CDA covering the clinical data. Tosk intends to prepare a manuscript reporting results from this trial combined with the results from the Phase 1b clinical trial. All the PIs will have a chance to review and approve the findings reported in the manuscript. Tosk expects to submit the manuscript for publication in early 2022.
Publication restrictions are in place

Restriction type: OTHER