Metastatic Solid TumorPhase 1EXCEEDNCT06238479
A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors
A Phase 1 study testing LY4101174 in people with Metastatic Solid Tumor and Recurrent Solid Tumor, run by Eli Lilly and Company at 28 sites in 7 countries.
Trial summary
The purpose of this study is to find out whether the study drug, LY4101174, is safe, tolerable and effective in participants with select advanced or metastatic solid tumors. The study is conducted in two parts - phase 1a (dose-escalation, dose-optimization) and phase 1b (dose-expansion). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumor, Recurrent Solid Tumor, Advanced Solid Tumor
- What is being tested?
- LY4101174
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 28 sitesin 7 countries
- Study dates
- 5 Mar 2024to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have one of the following solid tumor cancers:
- Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer
- Cohort A2/B1/B2: urothelial carcinoma
- Cohort C1: triple negative breast cancer
- Cohort C2: non-small cell lung cancer
- Cohort C3: ovarian or fallopian tube cancer
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- Cohort C4: cervical cancer
- Cohort C5: head and neck squamous cell carcinoma
- Prior Systemic Therapy Criteria:
- Cohort A1/C1-5: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies
- Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.
- Prior enfortumab vedotin specific requirements:
- Cohorts A1/A2/C1-5: prior treatment with enfortumab vedotin is allowed, but not required
- Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting
- Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.
- Measurability of disease
- Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
- Cohorts A2, B1, B2, C1-5: measurable disease required as defined by RECIST v1.1
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations
Who cannot join
- Individual with known or suspected uncontrolled CNS metastases
- Individual with uncontrolled hypercalcemia
- Individual with uncontrolled diabetes
- Individual with evidence of corneal keratopathy or history of corneal transplant
- Any serious unresolved toxicities from prior therapy
- Significant cardiovascular disease
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- Current of history of intestinal obstruction in the previous 3 months
- Recent thromboembolic event and/or clinically significant bleeding
- Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms
- History of pneumonitis/interstitial lung disease
- History of Grade ≥3 skin toxicity when receiving enfortumab vedotin
- Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
- Individual with active uncontrolled infection
Trial locations and contacts
28 sites in 7 countries.
28 sites in 7 countries
United States9 sites
Emory University
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114
UT Southwestern Medical Center
Dallas, Texas, 75390-8884
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
AdventHealth Orlando
Orlando, Florida, 32804
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229-3307
Washington University School of Medicine
St Louis, Missouri, 63110
France5 sites
Centre Oscar Lambret
Lille, 59020
Centre Leon Berard
Lyon, 69373
Institut Paoli-Calmettes
Marseille, 13273
CHU Strasbourg-Hautepierre
Strasbourg, 67098
Gustave Roussy
Villejuif, 94805
Japan4 sites
National Cancer Center Hospital
Chūōku, 104-0045
National Cancer Center Hospital East
Kashiwa, 277-8577
The Cancer Institute Hospital of JFCR
Kōtō City, 135-8550
Kyoto University Hospital
Kyoto, 606-8507
Spain4 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
MD Anderson Cancer Center
Madrid, 28033
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Virgen Del Rocio
Seville, 41013
China3 sites
Peking University First Hospital
Beijing, 100034
Hunan Cancer Hospital
Changsha, 410013
Shanghai East Hospital
Shanghai, 200433
Australia2 sites
Austin Health
Heidelberg, 3084
Icon Cancer Centre Kurralta Park
Kurralta Park, 5037
About this study
Official title: A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Recurrent, Advanced or Metastatic Solid Tumors
The purpose of this study is to find out whether the study drug, LY4101174, is safe, tolerable and effective in participants with select advanced or metastatic solid tumors. The study is conducted in two parts - phase 1a (dose-escalation, dose-optimization) and phase 1b (dose-expansion). The study will last up to approximately 4 years. Eligible patients will have the option to continue taking study drug after the study is complete.
Read the detailed description
This is a Phase 1a/1b multicenter, open-label study in participants with select advanced or metastatic solid tumors. This study is comprised of two phases: Dose Escalation and Dose Optimization (1a), and Dose expansion (1b). Phase 1a will assess the safety, tolerability, and pharmacokinetics of LY4101174 to determine the recommended phase 2 dose (RP2D)/optimal dose. Phase 1b will evaluate efficacy and safety of LY4101174 at the RP2D/optimal dose in 7 expansion cohorts based on tumor type and/or treatment history. At the completion of the trial, participants will have the option to continue receiving study drug at the discretion of the study doctor.
- Conditions
- Metastatic Solid Tumor, Recurrent Solid Tumor, Advanced Solid Tumor, Urinary Bladder Neoplasm, Triple Negative Breast Cancer, Non-small Cell Lung Cancer
- Being tested
- LY4101174
- Keywords
- Bladder Cancer, Bladder Neoplasm, Bladder Urothelial Carcinoma, Urinary Bladder Cancer, Urinary Tract Cancer, Urothelial Neoplasms, Renal Pelvis Cancer, Ureter Cancer, Nectin-4, Antibody Drug Conjugate (ADC)
- Medical subject headings
- Neoplasm Metastasis, Urinary Bladder Neoplasms, Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4101174Drug
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| LY4101174 (Dose-escalation, Cohort A1) | Experimental | Escalating doses of LY4101174 administered intravenously (IV). Receives: Drug: LY4101174 |
| LY4101174 (Dose-optimization, Cohort A2) | Experimental | Comparing 2 or more doses (evaluated during dose escalation) of LY4101174 administered IV. Receives: Drug: LY4101174 |
| LY4101174 (Dose-expansion, Cohort B1, B2, C1-C5) | Experimental | LY4101174 administered IV. Receives: Drug: LY4101174 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: To determine the recommended dose of LY4101174
Number of participants with dose-limiting toxicities (DLTs)
Measured: First 2 Cycles (28 days)
Phase 1a: To determine the recommended phase 2 dose (RP2D) or optimal dose of LY4101174
Number of participants with DLTs
Measured: First 2 Cycles (28 days)
Phase 1b: To assess the antitumor activity of LY4101174 Monotherapy: Overall response rate (ORR)
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Measured: Up to Approximately 48 Months or 4 Years
Secondary outcomes (8)
To characterize the pharmacokinetics (PK) properties of LY4101174: Minimum Plasma Concentration (Cmin)
PK: Cmin of LY4101174
Measured: First 4 cycles (56 days)
To characterize the PK properties of LY4101174: Area under the concentration versus time curve (AUC)
PK: AUC of LY4101174
Measured: First 4 cycles (56 days)
To evaluate the preliminary antitumor activity of LY4101174: Overall response rate (ORR)
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Measured: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Duration of response (DOR)
DOR per investigator assessed RECIST 1.1
Measured: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Time to response (TTR)
TTR per investigator assessed RECIST 1.1
Measured: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Progression free survival (PFS)
PFS per investigator assessed RECIST 1.1
Measured: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Disease control rate (DCR)
DCR per investigator assessed RECIST 1.1
Measured: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Overall survival (OS)
OS per investigator assessed RECIST 1.1
Measured: Up to Approximately 48 Months or 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start5 Mar 2024
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Solid TumorStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238479
- Sponsor's protocol ID
- 18836
- Other IDs
- J5A-OX-JZWA, 2023-509867-26-00, LOXO-ENC-23001, 2023
- Acronym
- EXCEED
- Status last verified
- May 2026
- First submitted
- 26 Jan 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Recurrent, Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06238479
- Acronym / sponsor ID
- EXCEED / 18836
- Conditions
- Metastatic Solid Tumor, Recurrent Solid Tumor, Advanced Solid Tumor, Urinary Bladder Neoplasm, Triple Negative Breast Cancer, Non-small Cell Lung Cancer
- Keywords
- Bladder Cancer, Bladder Neoplasm, Bladder Urothelial Carcinoma, Urinary Bladder Cancer, Urinary Tract Cancer, Urothelial Neoplasms, Renal Pelvis Cancer, Ureter Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 2 Feb 2024 (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.
The purpose of this study is to find out whether the study drug, LY4101174, is safe, tolerable and effective in participants with select advanced or metastatic solid tumors. The study is conducted in two parts - phase 1a (dose-escalation, dose-optimization) and phase 1b (dose-expansion). The study will last up to approximately 4 years. Eligible patients will have the option to continue taking study drug after the study is complete.
Detailed description
This is a Phase 1a/1b multicenter, open-label study in participants with select advanced or metastatic solid tumors. This study is comprised of two phases: Dose Escalation and Dose Optimization (1a), and Dose expansion (1b). Phase 1a will assess the safety, tolerability, and pharmacokinetics of LY4101174 to determine the recommended phase 2 dose (RP2D)/optimal dose. Phase 1b will evaluate efficacy and safety of LY4101174 at the RP2D/optimal dose in 7 expansion cohorts based on tumor type and/or treatment history. At the completion of the trial, participants will have the option to continue receiving study drug at the discretion of the study doctor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY4101174 (Dose-escalation, Cohort A1) | Experimental | Drug: LY4101174Escalating doses of LY4101174 administered intravenously (IV). |
| LY4101174 (Dose-optimization, Cohort A2) | Experimental | Drug: LY4101174Comparing 2 or more doses (evaluated during dose escalation) of LY4101174 administered IV. |
| LY4101174 (Dose-expansion, Cohort B1, B2, C1-C5) | Experimental | Drug: LY4101174LY4101174 administered IV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Have one of the following solid tumor cancers:
- Prior Systemic Therapy Criteria:
- Prior enfortumab vedotin specific requirements:
- Measurability of disease
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (13 listed)
- Individual with known or suspected uncontrolled CNS metastases
- Individual with uncontrolled hypercalcemia
- Individual with uncontrolled diabetes
- Individual with evidence of corneal keratopathy or history of corneal transplant
- Any serious unresolved toxicities from prior therapy
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 |
|---|---|---|
| LY4101174Intravenous | Drug | LY4101174 (Dose-escalation, Cohort A1), LY4101174 (Dose-expansion, Cohort B1, B2, C1-C5), LY4101174 (Dose-optimization, Cohort A2) |
Primary outcome
Phase 1a: To determine the recommended dose of LY4101174
Time frame: First 2 Cycles (28 days)
Number of participants with dose-limiting toxicities (DLTs)
Phase 1a: To determine the recommended phase 2 dose (RP2D) or optimal dose of LY4101174
Time frame: First 2 Cycles (28 days)
Number of participants with DLTs
Phase 1b: To assess the antitumor activity of LY4101174 Monotherapy: Overall response rate (ORR)
Time frame: Up to Approximately 48 Months or 4 Years
ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
8 secondary outcomes
To characterize the pharmacokinetics (PK) properties of LY4101174: Minimum Plasma Concentration (Cmin)
Time frame: First 4 cycles (56 days)
To characterize the PK properties of LY4101174: Area under the concentration versus time curve (AUC)
Time frame: First 4 cycles (56 days)
To evaluate the preliminary antitumor activity of LY4101174: Overall response rate (ORR)
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Duration of response (DOR)
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Time to response (TTR)
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Progression free survival (PFS)
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Disease control rate (DCR)
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4101174: Overall survival (OS)
Time frame: Up to Approximately 48 Months or 4 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid TumorsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
28 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY4101174 in people with Metastatic Solid Tumor and Recurrent Solid Tumor, run by Eli Lilly and Company at 28 sites in 7 countries.
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 20 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, France, Japan, Spain, China and 2 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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?
Phase 1a: To determine the recommended dose of LY4101174 (time frame: First 2 Cycles (28 days)). The study lists 3 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 22 May 2026.