Medpace

• The Phase 2 dose-expansion phase was not initiated.
• A 12 April 2023 protocol amendment revised prior-anticancer-therapy eligibility from requiring BRAFi-naive participants to requiring prior BRAFi treatment when appropriate.
• A 6 February 2024 protocol amendment added CFT1946 plus cetuximab arms for BRAF V600-mutant colorectal cancer and updated enrollment stopping rules and eligibility criteria.

These findings describe the trial, not the service provider’s performance or responsibility.

• The planned number of investigative sites was increased from 40 to 55.
• Weekly waking saliva collection was removed because of practical feasibility challenges and to reduce participant burden.
• Scheduled telephone contacts were reduced to lessen participant burden, while targeted as-needed contacts were retained or added for dose escalation, glucocorticoid tapering, safety monitoring, and compliance follow-up.
• COVID-19 mitigation measures allowed remote study visits and screening by telemedicine or at the participant's home where locally approved.
• Screening information collected within 45 days before Day 1 could be used when necessary, and screening data from the parallel SPR001-204 study could be transferred for eligibility determination.
• Eligibility criteria were revised to remove the elevated ACTH requirement, expand the acceptable glucocorticoid replacement range to 15-60 mg/day hydrocortisone equivalent, and update diagnostic and A4 requirements.

These findings describe the trial, not the service provider’s performance or responsibility.