Trial Outcomes & Findings for Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer (NCT NCT05245682)

Last Updated: 2026-01-08

Results Overview

Safety will be assessed on clinical examination and measurement of laboratory parameters. All safety assessments including adverse events, clinical laboratory evaluations, and vital signs will be summarized with descriptive statistics, where appropriate, and listed in the data listings using MedDRA terms.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

EARLY_PHASE1

Target enrollment

10 participants

Primary outcome timeframe

Up to 60 days post-treatment

Results posted on

2026-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Tolinapant, Radiation Therapy) Patients undergo standard of care radiation therapy for a total of 35 fractions over 7 weeks and receive tolinapant PO daily for 7 days during weeks 1, 3, 5, and 7 of radiation therapy in the absence of disease progression or unacceptable toxicity. Tolinapant: Given PO Radiation Therapy: Undergo radiation therapy
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Tolinapant, Radiation Therapy) n=10 Participants Patients undergo standard of care radiation therapy for a total of 35 fractions over 7 weeks and receive tolinapant PO daily for 7 days during weeks 1, 3, 5, and 7 of radiation therapy in the absence of disease progression or unacceptable toxicity. Tolinapant: Given PO Radiation Therapy: Undergo radiation therapy
Age, Categorical <=18 years	0 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=9 Participants
Age, Categorical >=65 years	7 Participants n=9 Participants
Age, Continuous	68.6 years STANDARD_DEVIATION 9.75 • n=9 Participants
Sex: Female, Male Female	2 Participants n=9 Participants
Sex: Female, Male Male	8 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	1 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	1 Participants n=9 Participants
Race (NIH/OMB) White	8 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Region of Enrollment United States	10 participants n=9 Participants

PRIMARY outcome

Timeframe: Up to 60 days post-treatment

Outcome measures

Outcome measures
Measure	Treatment (Tolinapant, Radiation Therapy) n=10 Participants Patients undergo standard of care radiation therapy for a total of 35 fractions over 7 weeks and receive tolinapant PO daily for 7 days during weeks 1, 3, 5, and 7 of radiation therapy in the absence of disease progression or unacceptable toxicity. Tolinapant: Given PO Radiation Therapy: Undergo radiation therapy
Safety of Tolinapant + Radiation (Number of Patients With Adverse Events Per CTCAE v5.0)	10 Participants

PRIMARY outcome

Timeframe: Upon completion of treatment

Feasibility is defined as completion of treatment, which will be reported as a percentage, with a 95% exact confidence interval using the Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Treatment (Tolinapant, Radiation Therapy) n=10 Participants Patients undergo standard of care radiation therapy for a total of 35 fractions over 7 weeks and receive tolinapant PO daily for 7 days during weeks 1, 3, 5, and 7 of radiation therapy in the absence of disease progression or unacceptable toxicity. Tolinapant: Given PO Radiation Therapy: Undergo radiation therapy
Feasibility of Tolinapant + Radiation (Number of Patients Able to Complete Treatment)	10 Participants

Adverse Events

Treatment (Tolinapant, Radiation Therapy)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Tolinapant, Radiation Therapy) n=10 participants at risk Patients undergo standard of care radiation therapy for a total of 35 fractions over 7 weeks and receive tolinapant PO daily for 7 days during weeks 1, 3, 5, and 7 of radiation therapy in the absence of disease progression or unacceptable toxicity. Tolinapant: Given PO Radiation Therapy: Undergo radiation therapy
Skin and subcutaneous tissue disorders Radiation Dermatitis	100.0% 10/10 • 2 years post treatment
General disorders Fatigue	90.0% 9/10 • 2 years post treatment
General disorders Anorexia	90.0% 9/10 • 2 years post treatment
Respiratory, thoracic and mediastinal disorders Throat/Tumor Pain	80.0% 8/10 • 2 years post treatment
Respiratory, thoracic and mediastinal disorders Dysphagia	80.0% 8/10 • 2 years post treatment
General disorders Dysgeusia	70.0% 7/10 • 2 years post treatment
Metabolism and nutrition disorders Nausea	50.0% 5/10 • 2 years post treatment
General disorders Dry Mouth	50.0% 5/10 • 2 years post treatment

Additional Information

Nicole Schmitt

Emory University

Phone: 404-778-0278

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place