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LYL273

Phase 1

Colorectal Cancer | Small molecule | Oncology |Lyell Immunopharma, Inc.|Last Updated: Jun 9, 2026

Target and mechanism

Molecular targetGCC
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment155

FDA Designations

FAST_TRACK

Clinical trial landscape

LYL273 · 1 trial · 1 indication

Phase 1 1
NCT05319314LYL273 for Patients With Relapsed or Refractory mCRCColorectal Cancer
RECRUITING155 Analytics
PHASE1RECRUITING
LYL273 for Patients With Relapsed or Refractory mCRC
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase 1: Incidence of adverse events (AEs) defined as dose-limiting toxicities (DLTs) during 3+3 dose escalation study
Infusion (Day 0) to Day 28
Phase 1: Maximum tolerable dose (MTD) based on incidence of dose-limiting toxicities (DLTs) during 3+3 dose escalation study
Infusion (Day 0) to Day 28
Phase 1: Recommended Phase 2 dose (RP2D) based on incidence of dose-limiting toxicities (DLTs) during 3+3 dose escalation study
Infusion (Day 0) to Day 28
Phase 2: Estimate the efficacy of LYL273, as measured by overall response rate (ORR) based on Independent Review Committee (IRC) assessment per Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 criteria
Baseline to Month 18

Secondary Endpoints

Phase 1 and 2: Evaluate the efficacy of LYL273
Infusion (Day 0) until the date of first documented confirmed complete or partial response per RECIST Version 1.1 criteria, assessed up to 18 months
Phase 2: Evaluate the efficacy of LYL273
Date of first documented confirmed complete or partial response per RECIST Version 1.1 criteria until the date of disease progression or recurrence or date of death whichever comes first
Phase 1 and 2: Overall Survival (OS)
Infusion (Day 0) until date of death from any cause
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LYL273EXPERIMENTALSingle infusion of LYL273 at the dose assigned to an individual participant. All participants will receive the same investigational therapy with the dose administered dependent upon the dose level they are assigned to in a sequential manner.

Interventions

NameTypeDescription
LYL273DRUGSingle infusion of Chimeric Antigen Receptor (CAR) transduced autologous T cells administered intravenously (i.v.)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Adults \> 18 years old * Clinical and histopathological diagnosis of relapsed or refractory metastatic colorectal cancer * Eastern Cooperative Oncology Group performance status of 0 or 1 * Limited liver disease (less than 7 lesions with largest lesion less than 3 cm) * No surg...

Countries:United States
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Recent Changes (Last 90 Days)

LOWJun 9, 2026NCT05319314lastUpdatePostDate: changed
LOWJun 9, 2026NCT05319314lastUpdatePostDate: changed
LOWJun 9, 2026NCT05319314lastUpdatePostDate: changed
LOWJun 9, 2026NCT05319314lastUpdatePostDate: changed
MEDIUMJun 3, 2026NCT05319314Enrollment: 30 → 155
MEDIUMJun 3, 2026NCT05319314Enrollment: 30 → 155

Frequently asked questions about LYL273

What is LYL273 used for?

LYL273 is an investigational small molecule being developed for the treatment of colorectal cancer. It is currently being studied in a Phase 1 clinical trial for patients with relapsed or refractory metastatic colorectal cancer (mCRC). The drug is not yet approved and remains in clinical development.

What does LYL273 target?

LYL273 targets GCC, a protein that is expressed in colorectal cancer cells. By targeting GCC, LYL273 is designed to interfere with cancer cell signaling. This mechanism is being evaluated in early-stage clinical trials to assess its safety and potential efficacy in patients with colorectal cancer.

Who makes LYL273?

LYL273 is being developed by Lyell Immunopharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LYEL. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with relapsed or refractory metastatic colorectal cancer.

What phase is LYL273 in?

LYL273 is currently in Phase 1 clinical development. The drug is being studied in an open-label, uncontrolled trial that is actively recruiting participants. It has not received FDA approval and is considered an investigational agent. The trial is designed to evaluate safety and dosing in patients with colorectal cancer.

What clinical trials is LYL273 in?

LYL273 is being evaluated in a single Phase 1 clinical trial with the identifier NCT05319314. This trial is titled 'LYL273 for Patients With Relapsed or Refractory mCRC' and is currently recruiting participants in the United States. The study plans to enroll approximately 155 patients with colorectal cancer.

Has LYL273 received FDA fast track designation?

Yes, LYL273 has received Fast Track designation from the U.S. Food and Drug Administration. This designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. The drug remains in Phase 1 clinical testing.