Recruiting

Oncology TreatmentsUmbrella Study for Single Patient Treatments in Oncology

Sponsor:

University Health Network, Toronto

Code:

NCT06285500

Conditions

Advanced Cancer

Rare Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patient-specific treatments

Study Details

Brief summary:

The purpose of this study is to collect data for assessing the improvement of the overall response rate for the overall cohorts and the proportion of patients accessing precision targeted therapy.

Conditions

Advanced Cancer

Rare Diseases

Study ID

NCT06285500

Start date

Feb 1, 2024

Status verified date

Dec, 2025

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria \& Exclusion Criteria:

Patient's existing genomic information from tumor molecular profiling will be discussed in the hospital expert molecular tumor board rounds consisting of representatives from specialist genomic profiling and medical oncology departments to decide N of 1 treatment for the patient. The discussion will surround the best next therapeutic option in the patient's cancer subtype with or without clear standard of care guidelines. Therefore, specific eligibility criteria aside from individual patient's medical history is not applicable.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Group 1

N-of-1 treatment with marketed drugs used on or off-label as per SOC.

Group 2

N-of-1 treatment with drugs accessed from SAP.

Group 3

N-of-1 treatment with non-marketed investigational agents.

Interventions

Patient-specific treatments

Treatment will be decided specifically for the patient based on biomarker test results.

Primary outcome measure

Overall response rate for the overall cohorts and the number of patients accessing precision targeted therapy [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Amit Oza, Dr.

416 946 4450 amit.oza@uhn.ca

Locations

University Health Network, Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Amit Oza, Dr.

416 946 4450 amit.oza@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Keywords

single patient protocols

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-12-16.