GalenOps prod · 0.1.0

Study · STC-15

STC-15 (METTL3 inhibitor) with toripalimab, and as monotherapy in selected sarcomas

recruiting NCT06975293

STC-15, oral METTL3 (m6A RNA methyltransferase) inhibitor

Phase Ib/II Dedifferentiated liposarcoma, uterine and non-uterine leiomyosarcoma; other advanced cancers Sponsor STORM Therapeutics FPI 2025-05-05

Study design

Design
Combination with toripalimab, plus Simon two-stage Phase 2 monotherapy in sarcoma open-label
Arms (2)
STC-15 + toripalimabSTC-15 monotherapy (sarcoma)
Primary endpoint
AEs (combination); ORR by RECIST at 6 months (sarcoma monotherapy)
Enrollment
3 of 107 target
Provenance

Sarcoma: 100 assets in the clinic, and who to call

Agentic orchestration

Runs all 13 lifecycle agents below in order; each records what it did, the evidence it used, and escalates to a human only on exception.

Horizon 3

Idle — the checklist below shows the last recorded state of every step.

Study lifecycle checklist 0 / 13

13 steps in trial order. Expand a step to see exactly what the agent did, the evidence it computed, and what it produced; steps needing a decision link to the review queue.

Re-assess feasibility with new inputs

Decisions awaiting you 4

Every escalation the agents raised on this study, decided here exactly as on the dashboard. Open an item's details before deciding; a note goes on the audit trail.

deciding as portal.reviewer
medium adverse_event · 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)

critical adverse_event · assess_serious_event

SAE — SAE Narrative Subject: NCT06975293-P02 Sex: F Age: 31 Treatment arm: STC-15 monotherapy (sarcoma) Event: Adverse event (uncoded; system organ class not yet assigned: [PENDING — human input]) Seriousness: Serious Grade (severity): Grade 3 Onset date: [PENDING — human input] Source/description: Participant-reported via Luna chat: "I've had a high fever since last night." Solicited symptom report; requires clinical characterization. Action taken with study treatment: [PENDING — human input] Outcome: [PENDING — human input] Date of resolution (if applicable): [PENDING — human input] Causality assessment (investigator): [PENDING — human [narrative drafted by claude-sonnet-5; verify against source fields]

critical adverse_event · assess_serious_event

SAE — SAE Narrative Subject: NCT06975293-P02 (31-year-old female), enrolled in the STC-15 monotherapy (sarcoma) treatment arm. Event: The subject experienced an adverse event, currently uncoded, graded as Grade 3 and classified as serious. System organ class: [PENDING — human input]. Source: Event was participant-reported via Luna chat, described as "high fever." This is a solicited symptom report that requires clinical characterization. [PENDING — human input] Onset: Onset date not recorded. [PENDING — human input] Causality: Investigator causality assessment has not been completed. Causality category: unassessed. [PEND [narrative drafted by claude-sonnet-5; verify against source fields]

medium adverse_event · 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)

Agent reasoning trail 0 runs

Explainable, traceable, inspection-ready — every automated action records why it did what it did and the evidence it used (FDA/EMA January 2026 AI guiding principles).

No agents have run on this study yet

Run agent pipeline records every step's reasoning and evidence here.

Protocol versions 0

Every version stays on file. Read any version in full; edit the newest to save the next draft and re-run the protocol agent's SPIRIT lint on it.

No protocol yet

Run the “Protocol drafted” step to create v0.1.

Sites 0

Every site contracted for this study or with a participant on it — with this study's contract stage and enrollment. Open a site for its full monitoring picture.

SiteCountryPrincipal investigatorSite statusContractParticipantsRisk

No sites on this study yet

Sites appear once a contract goes out to them or a participant is placed there. The site activation agent proposes the first wave.

All sites

Feasibility 0

No assessment yet

Use the form above to assess a region.

Supply forecasts 0

No forecast yet

Run the supply step to size the first kit order.

Regulatory submissions 0

Nothing submitted yet

The regulatory step compiles the IND/CTA once the protocol is approved.

Study documents 0 files

Everything generated or filed for this study. Open a file to preview it as a PDF.

No documents yet

Documents appear as the protocol, TLF and CSR steps run.