Advanced CancerPhase 1NCT04148937
A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer
A Phase 1 study testing LY3475070 and Pembrolizumab in people with Advanced Cancer, run by Eli Lilly and Company at 12 sites in 3 countries.
Trial summary
The reason for this study is to see if the CD73 inhibitor LY3475070 alone or in combination with pembrolizumab is safe and effective in participants with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- LY3475070 and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 16 Jan 2020to 20 Jun 2022
- 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
- Participants must have certain types of cancer such as breast cancer, pancreatic cancer, lung cancer, kidney cancer, skin cancer (melanoma), prostate cancer, and ovarian cancer
- Participants must have stopped other forms of treatment for the cancer
- In the expansion cohorts participants must be able and willing to provide a sample of the tumor before beginning treatment and a sample during the treatment. For certain tumor types, the result of a test on the tumor sample may exclude the participant from the study
- Participants must not be pregnant, and must agree to use birth control
- Participants must have progressed through or be intolerant to therapies with known clinical benefit
Who cannot join
- Participants must not have a current untreated tuberculosis, lung disease, heart disease, uncontrolled HIV, autoimmune disease, active hepatitis B or C virus infection or using corticosteroids
- Participant must not have cancer that has spread to the brain
- Participant must not have received a vaccine within the last 30 days
- Participant must not have had bowel obstruction within the last 6 months, or intestinal surgery
- Participant must not have an infection that is currently being treated
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States7 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Sarah Cannon Research Institute at HealthOne
Denver, Colorado, 80218
START Midwest
Grand Rapids, Michigan, 49546
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Florida Cancer Specialists ORLANDO/DDU
Lake Mary, Florida, 32746
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, 37203
Washington University Medical School
St Louis, Missouri, 63110
United Kingdom4 sites
Addenbrookes Hospital
Cambridge, Cambridgeshire, CB2 0QQ
Beatson West of Scotland Cancer Center
Glasgow, Scotland, G12 0YN
Christie NHS Foundation Trust
Manchester, M20 4 BX
Royal Marsden NHS Trust
Sutton, SM2 5PT
About this study
Official title: A Phase 1 Multicenter Global First in Human Study of the CD73 Inhibitor LY3475070 as Monotherapy or in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
The reason for this study is to see if the CD73 inhibitor LY3475070 alone or in combination with pembrolizumab is safe and effective in participants with advanced cancer.
- Conditions
- Advanced Cancer
- Being tested
- LY3475070, Pembrolizumab
- Keywords
- Triple Negative Breast Cancer, Pancreatic Cancer, Non-small Cell Lung Cancer, Renal Cell Carcinoma, Clear Cell, Cutaneous Melanoma, Castrate Resistant Prostate Cancer, Epithelial Ovarian Cancer, Metastatic Cancer
- Medical subject headings
- Triple Negative Breast Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Melanoma, Carcinoma, Ovarian Epithelial, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3475070Drug
Administered orally
PembrolizumabDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Cohort A LY3475070 (dose escalation) | Experimental | Participants received 150 milligram (mg) once daily or 300 mg once daily or 300mg twice daily or 600mg once daily oral LY3475070 on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met. Receives: Drug: LY3475070 |
| Phase 1a Cohort B LY3475070 + Pembrolizumab (dose escalation) | Experimental | Participants received 150 mg once daily or 150 mg twice daily or 300 mg once daily or 300mg twice daily oral LY3475070 on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met. Receives: Drug: LY3475070; Drug: Pembrolizumab |
| Phase 1b Cohort C1 LY3475070 + Pembrolizumab (dose expansion) | Experimental | LY3475070 administered orally and pembrolizumab administered IV.
Based on Sponsor decision, Phase 1b expansion cohorts were not initiated. Receives: Drug: LY3475070; Drug: Pembrolizumab |
| Phase 1b Cohort C2 LY3475070 (dose expansion) | Experimental | LY3475070 administered orally.
Based on Sponsor decision, Phase 1b expansion cohorts were not initiated. Receives: Drug: LY3475070 |
| Phase 1b Cohort D1 LY3475070 + Pembrolizumab (dose expansion) | Experimental | LY3475070 administered orally and pembrolizumab administered IV.
Based on Sponsor decision, Phase 1b expansion cohorts were not initiated. Receives: Drug: LY3475070; Drug: Pembrolizumab |
| Phase 1b Cohort D2 LY3475070 (dose expansion) | Experimental | LY3475070 administered orally.
Based on Sponsor decision, Phase 1b expansion cohorts were not initiated. Receives: Drug: LY3475070 |
| Phase 1b Cohort E LY3475070 + Pembrolizumab (dose expansion) | Experimental | LY3475070 administered orally and pembrolizumab administered IV.
Based on Sponsor decision, Phase 1b expansion cohorts were not initiated. Receives: Drug: LY3475070; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT is defined as an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events) version 5.0:
- Grade 3 thrombocytopenia associated with clinically significant bleeding and requiring platelet transfusion or Grade 4 thrombocytopenia of any duration.
- Grade ≥3 febrile neutropenia
- Grade ≥3 anemia requiring a blood transfusion
- Other Grade ≥4 toxicities, excluding few nonhematologic Toxicities
- Any other significant toxicity deemed by the investigatory to be dose-limiting, such as: any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during 28-day DLT observation period), persistent Grade >2 toxicities causing a delay of LY3475070 study treatment >14 days during the 28-day DLT observation period.
Measured: Up to 28 days from the first dose
Secondary outcomes (6)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Eight Hours (AUC[0-8]) of LY3475070
PK: AUC[0-8] of LY3475070.
Measured: Cycle 1 Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose)
PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCtau) of LY3475070
PK: AUCtau of LY3475070
Measured: Cycle 2 Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose for the QD arms, Pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose for the BID arms)
PK: Maximum Concentration (Cmax) of LY3475070
PK: Cmax of LY3475070
Measured: Day 1 of Cycles 1 and 2 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose for the QD arms; Pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose for the BID arms)
Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR)
ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator 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.
Measured: Baseline through Disease Progression or Death (Estimated at up to 10.4 Months)
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease (SD)
DCR is the percentage of participants with a best overall response of CR, PR or SD as defined by 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. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as 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 (Estimated at up to 10.4 Months)
Progression-Free Survival (PFS)
PFS is defined as the time from the date of start of treatment to the first date of the observed clinical or radiologically documented progressive disease or death due to any cause, whichever occurs first, was estimated and reported for all evaluable participants. For participants who were not known to have died or progressed as of the data-inclusion cut-off date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy.
Measured: Baseline to Objective Progression or Death Due to Any Cause (Estimated at up to 10.4 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start16 Jan 2020
- Primary completion12 May 2021
- Study completion20 Jun 2022
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 Advanced CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- 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
- NCT04148937
- Sponsor's protocol ID
- 17504
- Other IDs
- J2I-MC-JZMA, 2019-003270-64, Keynote A57, 2019
- Status last verified
- Apr 2024
- First submitted
- 31 Oct 2019
- Last updated
- 5 Apr 2024
- 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 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Multicenter Global First in Human Study of the CD73 Inhibitor LY3475070 as Monotherapy or in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT04148937
- Acronym / sponsor ID
- 17504
- Conditions
- Advanced Cancer
- Keywords
- Triple Negative Breast Cancer, Pancreatic Cancer, Non-small Cell Lung Cancer, Renal Cell Carcinoma, Clear Cell, Cutaneous Melanoma, Castrate Resistant Prostate Cancer, Epithelial Ovarian Cancer, Metastatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Posted 5 Apr 2024
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 CD73 inhibitor LY3475070 alone or in combination with pembrolizumab is safe and effective in participants with advanced cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Cohort A LY3475070 (dose escalation) | Experimental | Drug: LY3475070Participants received 150 milligram (mg) once daily or 300 mg once daily or 300mg twice daily or 600mg once daily oral LY3475070 on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met. |
| Phase 1a Cohort B LY3475070 + Pembrolizumab (dose escalation) | Experimental | Drug: LY3475070, Drug: PembrolizumabParticipants received 150 mg once daily or 150 mg twice daily or 300 mg once daily or 300mg twice daily oral LY3475070 on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met. |
| Phase 1b Cohort C1 LY3475070 + Pembrolizumab (dose expansion) | Experimental | Drug: LY3475070, Drug: PembrolizumabLY3475070 administered orally and pembrolizumab administered IV. Based on Sponsor decision, Phase 1b expansion cohorts were not initiated. |
| Phase 1b Cohort C2 LY3475070 (dose expansion) | Experimental | Drug: LY3475070LY3475070 administered orally. Based on Sponsor decision, Phase 1b expansion cohorts were not initiated. |
| Phase 1b Cohort D1 LY3475070 + Pembrolizumab (dose expansion) | Experimental | Drug: LY3475070, Drug: PembrolizumabLY3475070 administered orally and pembrolizumab administered IV. Based on Sponsor decision, Phase 1b expansion cohorts were not initiated. |
| Phase 1b Cohort D2 LY3475070 (dose expansion) | Experimental | Drug: LY3475070LY3475070 administered orally. Based on Sponsor decision, Phase 1b expansion cohorts were not initiated. |
| Phase 1b Cohort E LY3475070 + Pembrolizumab (dose expansion) | Experimental | Drug: LY3475070, Drug: PembrolizumabLY3475070 administered orally and pembrolizumab administered IV. Based on Sponsor decision, Phase 1b expansion cohorts were not initiated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must have certain types of cancer such as breast cancer, pancreatic cancer, lung cancer, kidney cancer, skin cancer (melanoma), prostate cancer, and ovarian cancer
- Participants must have stopped other forms of treatment for the cancer
- In the expansion cohorts participants must be able and willing to provide a sample of the tumor before beginning treatment and a sample during the treatment. For certain tumor types, the result of a test on the tumor sample may exclude the participant from the study
- Participants must not be pregnant, and must agree to use birth control
- Participants must have progressed through or be intolerant to therapies with known clinical benefit
Key exclusion criteria (5 listed)
- Participants must not have a current untreated tuberculosis, lung disease, heart disease, uncontrolled HIV, autoimmune disease, active hepatitis B or C virus infection or using corticosteroids
- Participant must not have cancer that has spread to the brain
- Participant must not have received a vaccine within the last 30 days
- Participant must not have had bowel obstruction within the last 6 months, or intestinal surgery
- Participant must not have an infection that is currently being treated
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 |
|---|---|---|
| LY3475070Administered orally | Drug | Phase 1a Cohort A LY3475070 (dose escalation), Phase 1a Cohort B LY3475070 + Pembrolizumab (dose escalation), Phase 1b Cohort C1 LY3475070 + Pembrolizumab (dose expansion), Phase 1b Cohort C2 LY3475070 (dose expansion), Phase 1b Cohort D1 LY3475070 + Pembrolizumab (dose expansion), Phase 1b Cohort D2 LY3475070 (dose expansion), Phase 1b Cohort E LY3475070 + Pembrolizumab (dose expansion) |
| PembrolizumabAdministered IV | Drug | Phase 1a Cohort B LY3475070 + Pembrolizumab (dose escalation), Phase 1b Cohort C1 LY3475070 + Pembrolizumab (dose expansion), Phase 1b Cohort D1 LY3475070 + Pembrolizumab (dose expansion), Phase 1b Cohort E LY3475070 + Pembrolizumab (dose expansion) |
Primary outcome
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days from the first dose
A DLT is defined as an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events) version 5.0: * Grade 3 thrombocytopenia associated with clinically significant bleeding and requiring platelet transfusion or Grade 4 thrombocytopenia of any duration. * Grade ≥3 febrile neutropenia * Grade ≥3 anemia requiring a blood transfusion * Other Grade ≥4 toxicities, excluding few nonhematologic Toxicities * Any other significant toxicity deemed by the investigatory to be dose-limiting, such as: any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during 28-day DLT observation period), persistent Grade >2 toxicities causing a delay of LY3475070 study treatment >14 days during the 28-day DLT observation period.
6 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Eight Hours (AUC[0-8]) of LY3475070
Time frame: Cycle 1 Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose)
PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCtau) of LY3475070
Time frame: Cycle 2 Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose for the QD arms, Pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose for the BID arms)
PK: Maximum Concentration (Cmax) of LY3475070
Time frame: Day 1 of Cycles 1 and 2 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose for the QD arms; Pre-dose, 0.5, 1, 2, 4, 6, 8 hours post-dose for the BID arms)
Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR)
Time frame: Baseline through Disease Progression or Death (Estimated at up to 10.4 Months)
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease (SD)
Time frame: Baseline through Measured Progressive Disease (Estimated at up to 10.4 Months)
Progression-Free Survival (PFS)
Time frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated at up to 10.4 Months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced CancerLink 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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3475070 and Pembrolizumab in people with Advanced Cancer, run by Eli Lilly and Company at 12 sites in 3 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: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, United Kingdom, Australia. 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 5 Apr 2024). 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 Dose Limiting Toxicities (DLTs) (time frame: Up to 28 days from the first dose). 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 5 Apr 2024.