Metastatic Solid TumorPhase 1NCT06561685
A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors
A Phase 1 study testing LY4050784, Pembrolizumab and Cisplatin in people with Metastatic Solid Tumor and Advanced Solid Tumor, run by Eli Lilly and Company at 32 sites in 6 countries.
Trial summary
The main purpose of this study is to find out whether the study drug, LY4050784, is safe, tolerable and effective in participants alone or in combination with other anticancer agents. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumor, Advanced Solid Tumor, Non-small Cell Lung Cancer
- What is being tested?
- LY4050784, Pembrolizumab and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 32 sitesin 6 countries
- Study dates
- 19 Sep 2024to Oct 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 locally advanced or metastatic solid tumor malignancy with SMARCA4 (BRG1) alteration:
- Phase 1a dose escalation: Presence of any alteration in SMARCA4 (BRG1)
- Phase 1b expansion: Part A: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or metastatic with presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.
- Phase 1b expansion: Part B: Any tumor type (other than NSCLC) that has the presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.
- Phase 1b expansion: Part C: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or metastatic with presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.
- Prior Systemic Therapy Criteria:
Show all 13Show fewer
- Phase 1a dose escalation and Phase 1b (Part B): Participants who received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating Investigator; or the individual is refusing the remaining most appropriate standard of care treatment; or there is no standard therapy available for the disease.
- Phase 1b expansion (Part A): Participants must have received at least one line of therapy for advanced or metastatic disease.
- Phase 1b expansion (Part C): Participants may be treatment naïve or have received therapy for advanced or metastatic disease
- Measurability of disease
- Phase 1a dose escalation (excluding backfill): measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
- Phase 1a backfill and Phase 1b expansion: Measurable disease required as defined by RECIST v1.1
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Who cannot join
- Participants with known or likely loss of function alteration of SMARCA2 (BRM) or malignancy with known association with SMARCA2 (BRM) alterations
- Prior exposure to SMARCA2 (BRM) inhibitor(s) and/or degrader(s) (prior exposure may be permitted for dose escalation)
- Participants with known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement
- Participants with history of increased risk of prolonged QT or significant arrythmia
- Significant cardiovascular disease
- Participants with active and/or treated for an additional primary malignancy within 2 years prior to enrolment
- Participants who are pregnant, breastfeeding or plan to breastfeed or expecting to conceive or father children during study or within 6 months after the last dose of study intervention
- Participants with history of active autoimmune diseases, history of allogenic stem cell/organ transplant or compromised immune system within past 2 years (Part C only)
Trial locations and contacts
32 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
32 sites in 6 countries
United States17 sites, 16 recruiting
- Recruiting
University of Colorado Health Hospital
Aurora, Colorado, 80045
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Ohio State University Hospital
Columbus, Ohio, 43210
- Recruiting
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, 80218
- Recruiting
USO-Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030-4009
- Active, not recruiting
Florida Cancer Specialists ORLANDO/DDU
Lake Mary, Florida, 32746
- Recruiting
University of Miami
Miami, Florida, 33136
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6307
- Recruiting
University of Chicago
New Lenox, Illinois, 60451
- Recruiting
Columbia University Medical Center
New York, New York, 10032
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
UCLA
Santa Monica, California, 90404
Japan4 sites, 4 recruiting
- Recruiting
National Cancer Center Hospital
Chūōku, 104-0045
- Recruiting
National Cancer Center Hospital East
Kashiwa, 277-8577
- Recruiting
The Cancer Institute Hospital of JFCR
Kōtō City, 135-8550
- Recruiting
Shizuoka Cancer Center
Nagaizumi-cho,Sunto-gun, 411-8777
France3 sites, 3 recruiting
- Not yet recruiting
Institut Bergonie
Bordeaux, 33 076
- Recruiting
Institut Curie
Paris, 75248
- Recruiting
Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP
Villejuif, 94800
Germany3 sites, 3 recruiting
- Recruiting
Charite-Universitatsmedizin Berlin
Berlin, 10117
- Recruiting
Universitaetsklinikum Essen
Essen, 45147
- Not yet recruiting
Krankenhaus Nordwest
Frankfurt am Main, 60488
South Korea3 sites, 3 recruiting
- Recruiting
National Cancer Center
Ilsandong-gu, 10408
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
- Recruiting
The Catholic University of Korea, St. Vincent's Hospital
Suwon, 16247
Spain2 sites, 2 recruiting
- Not yet recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
- Recruiting
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Madrid, 28040
About this study
Official title: An Open-label, Multicenter Study of LY4050784, a Selective SMARCA2/BRM Inhibitor, in Advanced Solid Tumor Malignancies With SMARCA4/BRG1 Alterations
The main purpose of this study is to find out whether the study drug, LY4050784, is safe, tolerable and effective in participants alone or in combination with other anticancer agents. In addition, with locally advanced or metastatic solid tumors with a BRG1 (Brahma-related gene 1, also known as SMARCA4) alteration who have previously received, do not qualify for, or are refusing standard of care treatments, or there is no standard therapy available for the disease. The study is conducted in two parts - phase Ia (dose-escalation) and phase Ib (dose-optimization, dose-expansion). The study will last up to approximately 4 years.
- Conditions
- Metastatic Solid Tumor, Advanced Solid Tumor, Non-small Cell Lung Cancer, SMARCA4-Deficient Tumor
- Being tested
- LY4050784, Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed
- Keywords
- SMARCA2, SMARCA4, Lung cancer, BRM, BRG1, Adenocarcinoma, Squamous cell carcinoma, Targeted therapy
- Medical subject headings
- Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Adenocarcinoma, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4050784Drug
Oral
PembrolizumabDrug
Administered IV.
CisplatinDrug
Administered IV.
CarboplatinDrug
Administered IV.
PemetrexedDrug
Administered IV.
PaclitaxelDrug
Administered IV.
Nab paclitaxelDrug
Administered IV.
| Study group | Role | What they receive |
|---|---|---|
| LY4050784 (Phase 1a - Dose Escalation) | Experimental | Escalating doses of LY4050784 administered orally. Receives: Drug: LY4050784 |
| LY4050784 (Phase 1b - Dose Optimization/Part A) | Experimental | Comparing 2 or more doses (evaluated during dose escalation) of LY4050784 administered orally. Receives: Drug: LY4050784 |
| LY4050784 (Phase 1b - Dose Expansion/Part B) | Experimental | LY4050784 administered orally. Receives: Drug: LY4050784 |
| LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C1 | Experimental | LY4050784 administered orally in combination in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met. Receives: Drug: LY4050784; Drug: Pembrolizumab |
| LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2a | Experimental | LY4050784 administered orally in combination in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met. Receives: Drug: LY4050784; Drug: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed |
| LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2b | Experimental | LY4050784 administered orally in combination in combination with pembrolizumab, paclitaxel/nab-paclitaxel and carboplatin administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met. Receives: Drug: LY4050784; Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ia: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs)
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module
Measured: Up to Approximately 48 Months or 4 Years
Phase 1a: To determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of LY4050784
Number of participants with dose-limiting toxicities (DLTs)
Measured: Up to Approximately 48 Months or 4 Years
Phase 1b: To assess the antitumor activity of LY4050784 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
Phase 1b (Dose optimization only): To confirm the RP2D/optimal dose based on safety and efficacy of LY4050784
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module, ORR and Duration of Response (DOR) per Investigator
Measured: Up to Approximately 48 Months or 4 Years
Phase 1b (Combination cohorts/Part C): To assess the safety and tolerability of LY4050784 when administered in combination with other anticancer agents
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module
Measured: Up to Approximately 48 Months or 4 Years
Secondary outcomes (11)
To characterize the pharmacokinetics (PK) properties of LY4050784: Maximum Concentration (Cmax)
PK: Cmax of LY4050784
Measured: Cycle 1 (Day 8)
To characterize the PK properties of LY4050784: Time to Maximum Concentration (Tmax)
PK: Tmax of LY4050784
Measured: Cycle 1 (Day 8)
To characterize the PK properties of LY4050784: Area under the concentration versus time curve (AUC)
PK: AUC of LY4050784
Measured: Cycle 1 (Day 8)
Phase Ia: To evaluate the preliminary antitumor activity of LY4050784: 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 LY4050784: 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 LY4050784: 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 LY4050784: 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 LY4050784: Progression free survival (PFS)
PFS per investigator assessed RECIST 1.1
Measured: Up to Approximately 48 Months or 4 Years
To evaluate the PK properties of LY4050784 in combination cohorts: Maximum Concentration (Cmax) PK: Cmax of LY4050784
Measured: Cycle 1 (Day 8)
To evaluate the PK properties of LY4050784 in combination cohorts: Time to Maximum Concentration (Tmax) PK: Tmax of LY4050784
Measured: Cycle 1 (Day 8)
To evaluate the PK properties of LY4050784 in combination cohorts: Area under the concentration versus time curve (AUC)
Measured: Cycle 1 (Day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start19 Sep 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 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
- 340 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
- NCT06561685
- Sponsor's protocol ID
- 27191
- Other IDs
- J5M-OX-JOXA
- Status last verified
- Nov 2026
- First submitted
- 16 Aug 2024
- Last updated
- 4 Nov 2026
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Study of LY4050784, a Selective SMARCA2/BRM Inhibitor, in Advanced Solid Tumor Malignancies With SMARCA4/BRG1 Alterations
- ClinicalTrials.gov ID
- NCT06561685
- Acronym / sponsor ID
- 27191
- Conditions
- Metastatic Solid Tumor, Advanced Solid Tumor, Non-small Cell Lung Cancer, SMARCA4-Deficient Tumor
- Keywords
- SMARCA2, SMARCA4, Lung cancer, BRM, BRG1, Adenocarcinoma, Squamous cell carcinoma, Targeted therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 20 Aug 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 main purpose of this study is to find out whether the study drug, LY4050784, is safe, tolerable and effective in participants alone or in combination with other anticancer agents. In addition, with locally advanced or metastatic solid tumors with a BRG1 (Brahma-related gene 1, also known as SMARCA4) alteration who have previously received, do not qualify for, or are refusing standard of care treatments, or there is no standard therapy available for the disease. The study is conducted in two parts - phase Ia (dose-escalation) and phase Ib (dose-optimization, dose-expansion). The study will last up to approximately 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LY4050784 (Phase 1a - Dose Escalation) | Experimental | Drug: LY4050784Escalating doses of LY4050784 administered orally. |
| LY4050784 (Phase 1b - Dose Optimization/Part A) | Experimental | Drug: LY4050784Comparing 2 or more doses (evaluated during dose escalation) of LY4050784 administered orally. |
| LY4050784 (Phase 1b - Dose Expansion/Part B) | Experimental | Drug: LY4050784LY4050784 administered orally. |
| LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C1 | Experimental | Drug: LY4050784, Drug: PembrolizumabLY4050784 administered orally in combination in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2a | Experimental | Drug: LY4050784, Drug: Pembrolizumab, Drug: Cisplatin, Drug: Carboplatin, Drug: PemetrexedLY4050784 administered orally in combination in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
| LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2b | Experimental | Drug: LY4050784, Drug: Pembrolizumab, Drug: Carboplatin, Drug: Paclitaxel, Drug: Nab paclitaxelLY4050784 administered orally in combination in combination with pembrolizumab, paclitaxel/nab-paclitaxel and carboplatin administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Have one of the following locally advanced or metastatic solid tumor malignancy with SMARCA4 (BRG1) alteration:
- Prior Systemic Therapy Criteria:
- Measurability of disease
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Key exclusion criteria (8 listed)
- Participants with known or likely loss of function alteration of SMARCA2 (BRM) or malignancy with known association with SMARCA2 (BRM) alterations
- Prior exposure to SMARCA2 (BRM) inhibitor(s) and/or degrader(s) (prior exposure may be permitted for dose escalation)
- Participants with known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement
- Participants with history of increased risk of prolonged QT or significant arrythmia
- Significant cardiovascular disease
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 |
|---|---|---|
| LY4050784Oral | Drug | LY4050784 (Phase 1a - Dose Escalation), LY4050784 (Phase 1b - Dose Expansion/Part B), LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C1, LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2a, LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2b, LY4050784 (Phase 1b - Dose Optimization/Part A) |
| PembrolizumabAdministered IV. | Drug | LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C1, LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2a, LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2b |
| CisplatinAdministered IV. | Drug | LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2a |
| CarboplatinAdministered IV. | Drug | LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2a, LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2b |
| PemetrexedAdministered IV. | Drug | LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2a |
| PaclitaxelAdministered IV. | Drug | LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2b |
| Nab paclitaxelAdministered IV. | Drug | LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2b |
Primary outcome
Phase Ia: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs)
Time frame: Up to Approximately 48 Months or 4 Years
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module
Phase 1a: To determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of LY4050784
Time frame: Up to Approximately 48 Months or 4 Years
Number of participants with dose-limiting toxicities (DLTs)
Phase 1b: To assess the antitumor activity of LY4050784 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)
Phase 1b (Dose optimization only): To confirm the RP2D/optimal dose based on safety and efficacy of LY4050784
Time frame: Up to Approximately 48 Months or 4 Years
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module, ORR and Duration of Response (DOR) per Investigator
Phase 1b (Combination cohorts/Part C): To assess the safety and tolerability of LY4050784 when administered in combination with other anticancer agents
Time frame: Up to Approximately 48 Months or 4 Years
A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module
11 secondary outcomes
To characterize the pharmacokinetics (PK) properties of LY4050784: Maximum Concentration (Cmax)
Time frame: Cycle 1 (Day 8)
To characterize the PK properties of LY4050784: Time to Maximum Concentration (Tmax)
Time frame: Cycle 1 (Day 8)
To characterize the PK properties of LY4050784: Area under the concentration versus time curve (AUC)
Time frame: Cycle 1 (Day 8)
Phase Ia: To evaluate the preliminary antitumor activity of LY4050784: Overall response rate (ORR)
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4050784: Duration of response (DOR)
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4050784: Time to response (TTR)
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4050784: Disease control rate (DCR)
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the preliminary antitumor activity of LY4050784: Progression free survival (PFS)
Time frame: Up to Approximately 48 Months or 4 Years
To evaluate the PK properties of LY4050784 in combination cohorts: Maximum Concentration (Cmax) PK: Cmax of LY4050784
Time frame: Cycle 1 (Day 8)
To evaluate the PK properties of LY4050784 in combination cohorts: Time to Maximum Concentration (Tmax) PK: Tmax of LY4050784
Time frame: Cycle 1 (Day 8)
To evaluate the PK properties of LY4050784 in combination cohorts: Area under the concentration versus time curve (AUC)
Time frame: Cycle 1 (Day 8)
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 4 Nov 2026.
- A Study of LY4050784 in Participants With 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.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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
32 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY4050784, Pembrolizumab and Cisplatin in people with Metastatic Solid Tumor and Advanced Solid Tumor, run by Eli Lilly and Company at 32 sites in 6 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 13 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Japan, France, Germany, South Korea and 1 more country. 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?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ia: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) (time frame: Up to Approximately 48 Months or 4 Years). The study lists 5 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 4 Nov 2026.