Sunday, February 22, 2026

Trial Detail

CT-LYA-301 Trial Detail

LYA-Onco 1 | Phase 3 | Recruiting

Protocol: LYA-301-P3
NCT: NCT05873011
Enrollment: 412/640

Protocol and Endpoints

Evidence and design details for provider screening conversations.

Sponsor

Lya Oncology Clinical Development

Adults with metastatic solid tumors after first-line progression with measurable disease.
Primary: Progression-free survival by blinded independent central review
Key secondary: Objective response rate and duration of response
Secondary: Overall survival interim analysis and symptom burden trend

Safety and Contact Pathways

How provider teams route scientific, safety, and site feasibility questions.

Infusion reaction observation required during cycle 1 and 2
Hepatic monitoring each cycle with dose modification algorithm
Pregnancy prevention counseling required at screening

Trial Referral Desk

Owner: Lya Clinical Operations

Channel: secure message

Medical Inquiry

Owner: Medical Information

Channel: MI case form

Site Feasibility

Owner: Regional trial manager

Channel: scheduled consult

Inclusion Highlights

Quick pre-screen items before referral.

Age >= 18 years
ECOG 0-1
Documented progression after first-line standard therapy
Adequate marrow, liver, and renal function
Tumor tissue available for biomarker analysis

Exclusion Highlights

Common reasons candidates are ruled out.

Untreated CNS metastases
Major surgery within 28 days
Active uncontrolled infection
Prior exposure to same target class within washout window

Referral Workflow

Provider-to-site handoff sequence.

Step 1

Provider pre-screens candidate against major criteria

Step 2

Site coordinator validates full inclusion/exclusion

Step 3

Study PI confirms final eligibility

Step 4

Consent visit scheduled and source packet prepared

Visit Timeline

Operational schedule used by coordinators and referring sites.

Screening (Day -21 to -1)

Consent, eligibility labs, imaging baseline

Cycle visits (Every 21 days)

Drug administration, AE review, labs

Imaging (Every 6 weeks)

Disease assessment and RECIST review

Follow-up (Q12 weeks)

Survival follow-up and late safety

Capture Trial Coordination Info

Add real referral and screening data from your site.

Add Trial Candidate

Track referral-ready candidates and next screening step.

Add Site Feasibility Note

Document site capacity, start-up blockers, or activation needs.