NCT06975293

Studies / Phase Ib/II

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

STORM Therapeutics · Dedifferentiated liposarcoma, uterine and non-uterine leiomyosarcoma; other advanced cancers

recruiting

Sites

0

Patients

4

Target N

107

Enrolled

3

Steps done

0/13

Decisions

4

Design

Title
STC-15 (METTL3 inhibitor) with toripalimab, and as monotherapy in selected sarcomas
Design
Combination with toripalimab, plus Simon two-stage Phase 2 monotherapy in sarcoma
Therapy
STC-15, oral METTL3 (m6A RNA methyltransferase) inhibitor
Primary endpoint
AEs (combination); ORR by RECIST at 6 months (sarcoma monotherapy)

Lifecycle

0 of 13 done

Feasibility assessed

Can this study realistically enroll — sites, patients, timeline?

not started

Protocol drafted & medically reviewed

A protocol synopsis exists, has been linted against SPIRIT, and is through medical review.

not started

Sites activation-ready

Every site's contract, activation and first-patient timeline is within benchmark.

not started

Recruitment funnel and screening plan

Enrollment funnel, accrual pace and eligibility yield computed; candidates to screen proposed per site (import is human-gated).

not started

Sites risk-scored

Per-site KRIs z-scored across the study; statistical outliers get a proposed on-site visit.

not started

Data cleaned

18 edit checks swept AE, DM, SV, EX and LB; deterministic queries auto-closed.

not started

Safety reports triaged

Every reported adverse event triaged with an E2A clock; serious ones with a physician.

not started

Dropout risk scored

Active patients scored; at-risk cohort proposed for outreach.

not started

Termination risk watched

Accrual curve, literature risk profile and registry comparators surveilled; termination itself stays a human decision.

not started

Drug supply forecast

Kits required over the horizon from observed dosing, accrual and discontinuation (partner IRT).

not started

TLFs generated & validated

ICH E3 Section 14 tables from live data (disposition, demographics, exposure, AEs, Kaplan-Meier efficacy), pending double-programming validation.

not started

CSR drafted & signed off

ICH E3 clinical study report assembled from study data; medical sign-off required.

not started

TMF inspection-ready

Trial master file audited against the DIA TMF Reference Model; gaps filed as QA findings.

not started

Sites

0

No sites contracted for this study yet.

Patients

4

NCT06975293-P01

enrolled

NCT06975293-P02

enrolled

NCT06975293-P03

enrolled

NCT06975293-P04

screened

Pending decisions

4

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)

medium

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

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]

critical

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)

medium