Innovating Access to Novel Therapies Through Standardized Prospective Integration of Response Evaluations (IMPACT-INSPIRE)

This observational study aims to assess the outcomes in patients with advanced treatment refractory cancers with matched molecular/precision therapy as per their molecular profiling results after discussion at molecular tumour board. 1. To standardize response assessment and data collection for patients that are receiving off-label or non-standard therapies based on MTB recommendations. \- Establish a standardized response assessment process and data collection patients that are receiving off-label or non-standard therapies based on MTB recommendations. 2. To demonstrate that it is feasible to standardize investigations and endpoints in this proof-of-concept study. * Through standard safety laboratory investigations (FBC, U/E/Cr, LFT) * Through standard radiological imaging at 6-12 weeks with the key endpoint being best response during that imaging window, and disease control rate at 6 months. Hypothesis: Our proposed IMPACT-INSPIRE study hypothesis is that standardised response assessment and data collection in patients with no available therapies receiving off-label systemic therapies, can provide a novel mechanism to assess oncological outcomes in this unique cohort of patients, generate hypothesis, and provide insights to future biomarker-driven drug development

NCT Number	NCT06956248
Lead Sponsor	National Cancer Centre, Singapore Collaborators: SingHealth Duke-NUS Academic Medical Centre
Conditions	Solid Tumor
Enrollment	50 participants
Start Date	2024-09-12
Primary Completion	2034-09-12 (estimated)
Study Completion	2035-03-12 (estimated)
Updated on ClinicalTrials.gov	2026-05-13