Solid TumorPhase 1NCT04099277
A Study of LY3435151 in Participants With Solid Tumors
A Phase 1 study testing LY3435151 and Pembrolizumab in people with Solid Tumor and Triple-negative Breast Cancer, run by Eli Lilly and Company at 2 sites in 2 countries.
Trial summary
The reason for this study is to see if the study drug LY3435151 is safe in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Triple-negative Breast Cancer, Gastric Adenocarcinoma
- What is being tested?
- LY3435151 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Oct 2019to 5 Mar 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participant must have certain types of cancer, which your study doctor will discuss with you
- Participant must have stopped other forms of treatment for cancer, which your study doctor will discuss with you
- Participant must be able and willing to provide a sample of your tumor before beginning treatment and once while on treatment. For certain tumor types, the outcome of the biopsy may exclude you from the study treatment (for Phase 1b)
- Participant must agree to use birth control
- Participant must have progressed through or are intolerant to therapies with known clinical benefit, which your study doctor will discuss with you
Who cannot join
- Participant must not have a history of tuberculosis, uncontrolled HIV or uncontrolled hepatitis B or C virus infection
- Participant must not have an autoimmune disease, which your study doctor will discuss with you
- Participant must not use corticosteroids, which your study doctor will discuss with you
- Participant must not have heart disease, Crohn's disease or brain cancer
- Participant must not be pregnant or breastfeeding
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase 1a/1b Study of LY3435151 Administered to Patients With Advanced Solid Tumors
The reason for this study is to see if the study drug LY3435151 is safe in participants with advanced solid tumors.
- Conditions
- Solid Tumor, Triple-negative Breast Cancer, Gastric Adenocarcinoma, Head and Neck Squamous Cell Carcinoma, Cervical Carcinoma, High Grade Serous Ovarian Carcinoma
- Being tested
- LY3435151, Pembrolizumab
- Keywords
- immunotherapy, CD226 agonist
- Medical subject headings
- Triple Negative Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck, Uterine Cervical Neoplasms, Carcinoma, Hepatocellular, Histiocytoma, Malignant Fibrous, Leiomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3435151Drug
Administered IV
PembrolizumabDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Part A: 10 milligrams (mg) LY3435151 | Experimental | Participants received intravenous (IV) push or IV bolus infusion of 10 mg LY3435151. Receives: Drug: LY3435151 |
| Part B: LY3435151 + Pembrolizumab Dose Escalation | Experimental | Pembrolizumab was not administered as study was terminated before completion of Part A of the dose escalation period. Receives: Drug: LY3435151; Drug: Pembrolizumab |
| Part C: LY3435151 Dose Expansion | Experimental | Participants were not enrolled in to this arm, as trial was terminated in dose escalation phase. Receives: Drug: LY3435151 |
| Part D: LY3435151 + Pembrolizumab Dose Expansion | Experimental | Participants were not enrolled in to this arm, as trial was terminated in dose escalation phase. Receives: Drug: LY3435151; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With LY3435151 Dose-Limiting Toxicities (DLTs)
A DLT is defined as an Adverse Event that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0:
- Any death not clearly due to the underlying disease or extraneous causes
- Neutropenic fever 2. Any Grade ≥3 non-hematologic toxicity
- Grade ≥4 neutropenia or thrombocytopenia >7 days
- Grade ≥3 thrombocytopenia with bleeding
- Grade ≥3 nausea/vomiting or diarrhea>72 hours with adequate antiemetic and other supportive care
- Grade ≥3 fatigue ≥1 week
- Grade ≥3 electrolyte abnormality that lasts>72 hours, unless the Participant has clinical symptoms, in which case all Grade 3+electrolyte abnormality regardless of duration should count as a DLT
- Grade ≥3 prolongation of QT interval corrected using the Fridericia formula on 2 separate electrocardiogram readings approximately 5 min apart.
Measured: Baseline through Cycle 2 (21 Day Cycles)
Secondary outcomes (7)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151.
Measured: Cycle 1 Day 1 (C1D1) (Predose, 1, 3 hour (hr), C1D2 (24 hr), C1D4 (72hr), C1D8 (168hr), C1D15 (336hr)
PK: Cmax of LY3435151 in Combination With Pembrolizumab
PK: Cmax of LY3435151 in Combination with Pembrolizumab.
Measured: Predose Cycle 1 Day 1 through Predose Cycle 5 Day 1 (21 Day Cycles)
Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR)
Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100.
Measured: Baseline through Disease Progression or Death (Up to 4 Months)
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease
Disease Control Rate (DCR) is the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Measured: Baseline through Measured Progressive Disease (Up to 4 Months)
Duration of Response (DoR)
DOR is the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Measured: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 4 Months)
Time to Response (TTR)
Time to response (TTR) is defined as the time from the date of start of treatment to the date measurement criteria for confirmed CR or PR (whichever is first recorded) are first met. For participants who are not known to have achieved CR or PR as of the data inclusion cut-off date, TTR will be censored at the date of the last objective disease assessment prior the date of any subsequent systematic anticancer therapy.
Measured: Baseline to Date of CR or PR (Up to 4 Months)
Progression Free Survival (PFS)
PFS time was measured from the date of randomization until the first radiographic documentation of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Measured: Baseline to Objective Progression or Death Due to Any Cause (Up to 4 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start28 Oct 2019
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
Why it stopped: Study terminated due to strategic business decision by Eli Lilly and Company.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- 2 participants (actual)
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099277
- Sponsor's protocol ID
- 17364
- Other IDs
- J1Q-MC-JZIA
- Status last verified
- Aug 2021
- First submitted
- 20 Sep 2019
- Last updated
- 31 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Study of LY3435151 Administered to Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04099277
- Acronym / sponsor ID
- 17364
- Conditions
- Solid Tumor, Triple-negative Breast Cancer, Gastric Adenocarcinoma, Head and Neck Squamous Cell Carcinoma, Cervical Carcinoma, High Grade Serous Ovarian Carcinoma
- Keywords
- immunotherapy, CD226 agonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to strategic business decision by Eli Lilly and Company.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Posted 31 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The reason for this study is to see if the study drug LY3435151 is safe in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: 10 milligrams (mg) LY3435151 | Experimental | Drug: LY3435151Participants received intravenous (IV) push or IV bolus infusion of 10 mg LY3435151. |
| Part B: LY3435151 + Pembrolizumab Dose Escalation | Experimental | Drug: LY3435151, Drug: PembrolizumabPembrolizumab was not administered as study was terminated before completion of Part A of the dose escalation period. |
| Part C: LY3435151 Dose Expansion | Experimental | Drug: LY3435151Participants were not enrolled in to this arm, as trial was terminated in dose escalation phase. |
| Part D: LY3435151 + Pembrolizumab Dose Expansion | Experimental | Drug: LY3435151, Drug: PembrolizumabParticipants were not enrolled in to this arm, as trial was terminated in dose escalation phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must have certain types of cancer, which your study doctor will discuss with you
- Participant must have stopped other forms of treatment for cancer, which your study doctor will discuss with you
- Participant must be able and willing to provide a sample of your tumor before beginning treatment and once while on treatment. For certain tumor types, the outcome of the biopsy may exclude you from the study treatment (for Phase 1b)
- Participant must agree to use birth control
- Participant must have progressed through or are intolerant to therapies with known clinical benefit, which your study doctor will discuss with you
Key exclusion criteria (5 listed)
- Participant must not have a history of tuberculosis, uncontrolled HIV or uncontrolled hepatitis B or C virus infection
- Participant must not have an autoimmune disease, which your study doctor will discuss with you
- Participant must not use corticosteroids, which your study doctor will discuss with you
- Participant must not have heart disease, Crohn's disease or brain cancer
- Participant must not be pregnant or breastfeeding
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 |
|---|---|---|
| LY3435151Administered IV | Drug | Part A: 10 milligrams (mg) LY3435151, Part B: LY3435151 + Pembrolizumab Dose Escalation, Part C: LY3435151 Dose Expansion, Part D: LY3435151 + Pembrolizumab Dose Expansion |
| PembrolizumabAdministered IV | Drug | Part B: LY3435151 + Pembrolizumab Dose Escalation, Part D: LY3435151 + Pembrolizumab Dose Expansion |
Primary outcome
Number of Participants With LY3435151 Dose-Limiting Toxicities (DLTs)
Time frame: Baseline through Cycle 2 (21 Day Cycles)
A DLT is defined as an Adverse Event that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0: 1. Any death not clearly due to the underlying disease or extraneous causes 2. Neutropenic fever 2. Any Grade ≥3 non-hematologic toxicity 3. Grade ≥4 neutropenia or thrombocytopenia >7 days 4. Grade ≥3 thrombocytopenia with bleeding 5. Grade ≥3 nausea/vomiting or diarrhea>72 hours with adequate antiemetic and other supportive care 6. Grade ≥3 fatigue ≥1 week 7. Grade ≥3 electrolyte abnormality that lasts>72 hours, unless the Participant has clinical symptoms, in which case all Grade 3+electrolyte abnormality regardless of duration should count as a DLT 8. Grade ≥3 prolongation of QT interval corrected using the Fridericia formula on 2 separate electrocardiogram readings approximately 5 min apart.
7 secondary outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151
Time frame: Cycle 1 Day 1 (C1D1) (Predose, 1, 3 hour (hr), C1D2 (24 hr), C1D4 (72hr), C1D8 (168hr), C1D15 (336hr)
PK: Cmax of LY3435151 in Combination With Pembrolizumab
Time frame: Predose Cycle 1 Day 1 through Predose Cycle 5 Day 1 (21 Day Cycles)
Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR)
Time frame: Baseline through Disease Progression or Death (Up to 4 Months)
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease
Time frame: Baseline through Measured Progressive Disease (Up to 4 Months)
Duration of Response (DoR)
Time frame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 4 Months)
Time to Response (TTR)
Time frame: Baseline to Date of CR or PR (Up to 4 Months)
Progression Free Survival (PFS)
Time frame: Baseline to Objective Progression or Death Due to Any Cause (Up to 4 Months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Study of LY3435151 in Participants With Solid TumorsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3435151 and Pembrolizumab in people with Solid Tumor and Triple-negative Breast Cancer, run by Eli Lilly and Company at 2 sites in 2 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 5 inclusion and 5 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 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Japan. 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?
Yes. Results are posted in the registry (first posted 31 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With LY3435151 Dose-Limiting Toxicities (DLTs) (time frame: Baseline through Cycle 2 (21 Day Cycles)). 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 31 Aug 2021.