MelanomaPhase 1NCT05573035
A Study to Investigate LYL845 in Adults With Solid Tumors
A Phase 1 study testing LYL845 in people with Melanoma and Non-small Cell Lung Cancer, run by Lyell Immunopharma, Inc. at 18 sites in United States.
Trial summary
This is an open-label, multi-center, dose-escalation study with expansion cohorts, designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma, Non-small Cell Lung Cancer, Colorectal Cancer
- What is being tested?
- LYL845
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 18 sitesUnited States
- Study dates
- 19 Dec 2022to 9 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years up to ≤ 75 years at the time of informed consent
- Confirmed diagnosis of melanoma, non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) that is metastatic or locally advanced or unresectable and is relapsed and/or refractory (R/R) after standard therapy for each tumor histology
- Participants must have received prior systemic treatment for their metastatic disease or locally advanced disease based on tumor type as follows:
- Melanoma: participants with disease progression following an immune checkpoint inhibitor (CPI)
- NSCLC: participants with disease progression following at least 1 approved systemic therapy, including an immune CPI-containing regimen for appropriate patients or an approved targeted therapy for known molecular abnormalities if applicable to their disease
- CRC: participants with disease progression following at least 1 line of therapy, including a fluoropyrimidine with oxaliplatin or irinotecan. Microsatellite instability (MSI) high/mismatch repair deficient (dMMR) CRC participants must have disease progression following systemic therapy with immune CPIs.
Show all 12Show fewer
- Measurable disease including at least 1 lesion that is safely resectable AND a target lesion to measure response and an additional lesion for biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and marrow function
- Women of childbearing potential must have a negative pregnancy test at screening
- All participants must agree to practice highly effective methods of contraception
- Fully recovered from toxicity from prior systemic anticancer therapy
Who cannot join
- Prior treatment with adoptive cellular therapy
- Prior solid organ transplantation
- Central nervous system (CNS) involvement of disease that is extensive, symptomatic or untreated, or patients with leptomeningeal disease
- Uncontrolled or symptomatic pleural effusion or ascites
- Untreated or active systemic infection
- Active autoimmune disease requiring treatment or primary immunodeficiency syndrome
Show all 11Show fewer
- Systemic corticosteroids at a dose of >10 mg of prednisone or equivalent per day
- Other primary malignancy within 3 years prior to enrollment
- Impaired cardiac function or clinically significant cardiovascular disease
- Required chronic anticoagulation, such as warfarin, low molecular weight heparin, or Factor Xa inhibitors
- Pregnant or nursing (lactating) women
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Ohio State University Medical Center
Columbus, Ohio, 43210
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
Duke University Medical Center
Durham, North Carolina, 27710
Hackensack Meridian Health Inc
Hackensack, New Jersey, 07601
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Yale Cancer Center, Yale University
New Haven, Connecticut, 06511
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15224
Oregon Health Sciences University
Portland, Oregon, 97239
Mayo Clinic Comprehensive Cancer Center
Rochester, Minnesota, 55905
UC Davis Coomprehensive Cancer Center
Sacramento, California, 95817
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
UCLA Medical Center
Santa Monica, California, 90404
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Stanford University
Stanford, California, 94305
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase 1 Study to Assess the Safety and Efficacy of LYL845 in Adults With Relapsed and/or Refractory Metastatic or Locally Advanced Melanoma and Selected Solid Tumor Malignancies
This is an open-label, multi-center, dose-escalation study with expansion cohorts, designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC).
Read the detailed description
This is an open-label, multi-center, dose-escalation study with expansion cohorts, designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). During the dose-escalation phase of the study (Part A), participants with melanoma will be enrolled. Once a safe recommended Phase 2 dose range (RP2DR) has been established in Part A, enrollment will be expanded (Part B) to include additional participants with melanoma, NSCLC and CRC.
- Conditions
- Melanoma, Non-small Cell Lung Cancer, Colorectal Cancer
- Being tested
- LYL845
- Keywords
- TIL, tumor infiltrating lymphocyte, melanoma, non-small cell lung cancer, colorectal cancer, NSCLC, CRC, relapsed, refractory, locally advanced, advanced, metastatic, epigenetic
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYL845Biological
LYL845 is an autologous tumor infiltrating lymphocyte (TIL) enhanced via Epi-R, a proprietary epigenetic reprogramming technology
| Study group | Role | What they receive |
|---|---|---|
| Experimental LYL845 | Experimental | Epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy Receives: Biological: LYL845 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs)
Evaluate incidence of dose-limiting toxicities (DLTs)
Measured: Up to 28 days
Incidence of treatment-emergent adverse events (TEAEs)
Evaluate incidence of treatment-emergent adverse events (TEAEs)
Measured: Up to 2 years
Severity of treatment-emergent adverse events (TEAEs)
Evaluate severity of treatment-emergent adverse events (TEAEs)
Measured: Up to 2 years
Determine recommended Phase 2 Dose Range (RP2DR)
Determine the recommended Phase 2 dose range (during dose-escalation phase)
Measured: Up to 2 years
Secondary outcomes (4)
Overall response rate (ORR) by RECIST, version 1.1
Evaluate anti-tumor activity of LYL845 based on overall response rate (ORR) by RECIST, version 1.1
Measured: up to 2 years
Duration of response (DOR)
Evaluate duration of response (DOR)
Measured: up to 2 years
Progression-free survival (PFS)
Evaluate progression-free survival (PFS)
Measured: up to 2 years
Overall survival (OS)
Evaluate overall survival (OS)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start19 Dec 2022
- Primary completion9 Jan 2025
- Study completion9 Jan 2025
Why it stopped: Pipeline Reprioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, open-label, dose-escalation and -expansion study
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyell Immunopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573035
- Sponsor's protocol ID
- LYL845-101
- Status last verified
- Jun 2025
- First submitted
- 6 Oct 2022
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Safety and Efficacy of LYL845 in Adults With Relapsed and/or Refractory Metastatic or Locally Advanced Melanoma and Selected Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT05573035
- Acronym / sponsor ID
- LYL845-101
- Conditions
- Melanoma, Non-small Cell Lung Cancer, Colorectal Cancer
- Keywords
- TIL, tumor infiltrating lymphocyte, melanoma, non-small cell lung cancer, colorectal cancer, NSCLC, CRC, relapsed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pipeline Reprioritization
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Lyell Immunopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multi-center, dose-escalation study with expansion cohorts, designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC).
Detailed description
This is an open-label, multi-center, dose-escalation study with expansion cohorts, designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). During the dose-escalation phase of the study (Part A), participants with melanoma will be enrolled. Once a safe recommended Phase 2 dose range (RP2DR) has been established in Part A, enrollment will be expanded (Part B) to include additional participants with melanoma, NSCLC and CRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, open-label, dose-escalation and -expansion study
| Arm | Type | Receives |
|---|---|---|
| Experimental LYL845 | Experimental | Biological: LYL845Epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years up to ≤ 75 years at the time of informed consent
- Confirmed diagnosis of melanoma, non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) that is metastatic or locally advanced or unresectable and is relapsed and/or refractory (R/R) after standard therapy for each tumor histology
- Participants must have received prior systemic treatment for their metastatic disease or locally advanced disease based on tumor type as follows:
- Melanoma: participants with disease progression following an immune checkpoint inhibitor (CPI)
- NSCLC: participants with disease progression following at least 1 approved systemic therapy, including an immune CPI-containing regimen for appropriate patients or an approved targeted therapy for known molecular abnormalities if applicable to their disease
Key exclusion criteria (11 listed)
- Prior treatment with adoptive cellular therapy
- Prior solid organ transplantation
- Central nervous system (CNS) involvement of disease that is extensive, symptomatic or untreated, or patients with leptomeningeal disease
- Uncontrolled or symptomatic pleural effusion or ascites
- Untreated or active systemic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LYL845LYL845 is an autologous tumor infiltrating lymphocyte (TIL) enhanced via Epi-R, a proprietary epigenetic reprogramming technology | Biological | Experimental LYL845 |
Primary outcome
Incidence of dose-limiting toxicities (DLTs)
Time frame: Up to 28 days
Evaluate incidence of dose-limiting toxicities (DLTs)
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 years
Evaluate incidence of treatment-emergent adverse events (TEAEs)
Severity of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 years
Evaluate severity of treatment-emergent adverse events (TEAEs)
Determine recommended Phase 2 Dose Range (RP2DR)
Time frame: Up to 2 years
Determine the recommended Phase 2 dose range (during dose-escalation phase)
4 secondary outcomes
Overall response rate (ORR) by RECIST, version 1.1
Time frame: up to 2 years
Duration of response (DOR)
Time frame: up to 2 years
Progression-free survival (PFS)
Time frame: up to 2 years
Overall survival (OS)
Time frame: up to 2 years
Results and safety
The study was stopped early (reason given: Pipeline Reprioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LYL845 in people with Melanoma and Non-small Cell Lung Cancer, run by Lyell Immunopharma, Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Pipeline Reprioritization). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs) (time frame: Up to 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.