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• 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 study assessed 2 patients and treated 1 patient before termination.
• Delayed study start-up and slow patient recruitment prevented completion of planned enrollment on time.

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

• The trial enrolled 35 healthy subjects at one investigative site in the Netherlands between 18 October 2023 and 28 March 2024.
• All subjects in the 1500 mg/Q12h cohort discontinued before Day 10, precluding Day 10 pharmacokinetic assessments for this cohort.
• A protocol amendment added ultrasound inspection at follow-up after PICC-line removal to monitor safety and well-being.

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

• Approximately 50% of the first 22 Part 1 participants experienced on-treatment ALT elevations, and protocol management criteria were amended because some elevations were prolonged.
• New enrollment was temporarily halted in December 2022 after significant ALT elevations were observed more frequently in Part 2 participants with screening or baseline HBsAg >10,000 IU/mL.
• Enrollment was not reopened because the sponsor discontinued further investment in its hepatitis B and D discovery and development programs.
• Part 2 open-label treatment was reduced to Week 96 and follow-up to 24 weeks under protocol amendment 5.
• Sustained HBV response was not collected or analyzed because follow-up was shortened and participants continued NA treatment during follow-up.

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

• One participant signed informed consent but did not receive investigational product and was screen failed.
• No treatment-emergent safety or efficacy data were generated or collected.

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

• Recruitment began on 1 March 2022, and 98 participants were randomized at 57 sites in 19 countries.
• A May 2022 amendment changed the primary endpoint from complete remission on minimal OCS to CRoff at week 36 and added CRmin and IGA-BP-off-OCS secondary endpoints.
• Infection-related eligibility criteria were tightened across amendments, including exclusion of active or chronic infections and later clinically significant active infection unresolved before baseline.
• A March 2023 amendment added exclusions for latent infection, severe renal impairment, specified safety or procedure-affecting conditions, concurrent interventional-study enrollment, inadequately treated HIV, and recent live or live-attenuated vaccination.
• Sponsor confirmation of participant eligibility was removed in the March 2023 amendment.
• The March 2023 amendment required at least 30 minutes of on-site safety monitoring after investigational-product administration, and this requirement was removed in February 2024.
• The Day 10 PK sampling requirement in Part A was clarified to require samples from at least 28 participants rather than all participants.
• All adverse events in the MedDRA Infections and Infestations system organ class were designated adverse events of special interest in the May 2022 amendment.

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