Luca-1: SHY-ONC6 (19S proteasome ATPase inhibitor) in advanced solid tumours

assess serious event

Non-serious event needing physician assessment — Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)

assess serious event

SAE — SAE Narrative Subject NCT07705334-P02 is a 57-year-old female enrolled in study NCT07705334, treatment arm: [PENDING — human input]. The subject experienced a serious adverse event (Grade 3), currently uncoded, as reported via participant-reported source: Luna chat message, "I've had a high fever since last night." This was a solicited symptom report and requires clinical characterization. Onset date: [PENDING — human input] System organ class: [PENDING — human input] Action taken with study treatment: [PENDING — human input] Outcome: [PENDING — human input] Date of resolution (if applicable): [PENDING — human input] Death within 30 days of event: No Causality: Investigator causality assessment has not yet been recorded. [PENDING — human input] Expectedness: Expectedness undetermined — event not yet coded. [PENDING — human input] Regulatory Reporting: This event has been classified as serious. Per ICH E2A requirements, an expedited report is due on 2026-10-23, consistent with the 15-day reporting clock applicable to other serious unexpected events. This narrative will be updated upon receipt of additional clinical information, including invest [narrative drafted by claude-sonnet-5; verify against source fields]

assess serious event

SAE — SAE Narrative Subject NCT07705334-P02 (57-year-old female; treatment arm: [PENDING — human input]) experienced a serious adverse event, Grade 3 in severity. The event has not yet been coded; the uncoded term is based on participant-reported information via Luna chat ("high fever"), a solicited symptom report that requires clinical characterization. Onset date: [PENDING — human input] System organ class: [PENDING — human input] Action taken with study treatment: [PENDING — human input] Outcome: [PENDING — human input] Resolution date: [PENDING — human input] Investigator causality assessment: not assessed — investigator assessment required. Expectedness: expectedness undetermined — event not yet coded. Seriousness: serious. Death within 30 days of event: no. Regulatory reporting: This event falls under the 15-day expedited reporting timeline (other serious, unexpected) per ICH E2A. The expedited report is due on 2026-10-23. Additional clinical details, including a fully characterized diagnosis, SOC/coded term, and investigator causality assessment, are pending and required prior to finalization of this narrative. [narrative drafted by claude-sonnet-5; verify against source fields]

assess serious event

Non-serious event needing physician assessment — Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)

luna withdrawal signal

Participant Kenji Mori voiced withdrawal intent to Luna. Site coordinator outreach requested — participation is voluntary; only support, never pressure.

luna low mood followup

Participant Kenji Mori has reported feeling 2/5 then 2/5 in consecutive Luna check-ins. Proactive site outreach proposed.