Solid TumorPhase 1NCT02737072

A Study of LY2510924 and Durvalumab in Participants With Solid Tumors

A Phase 1 study testing LY2510924 and Durvalumab in people with Solid Tumor, run by Eli Lilly and Company.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The main purpose of this study is to evaluate the safety and tolerability of chemokine (C-X-C Motif) receptor 4 (CXCR4) peptide antagonist LY2510924 and durvalumab for phase 1a and 1b in participants with advanced refractory solid tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor
What is being tested?: LY2510924 and Durvalumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: No sites listed yet
Study dates: Sep 2016to 25 Sep 2017
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

Phase 1a: Have histologic or cytologic confirmation of advanced solid tumor
Have at least 1 measurable lesion assessable using standard techniques by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Have adequate organ function
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Have provided tissue from a newly obtained core or excisional biopsy of a tumor lesion or a recent biopsy defined by ≤3 years since last documented progression of disease
Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator

Who cannot join

Have a serious concomitant systemic disorder including human immunodeficiency virus (HIV), active hepatitis B virus (HBV), active HCV, active autoimmune disorder or disease requiring high dose of steroids
Have a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection or chronic diarrhea
Have evidence of interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity or active, noninfectious pneumonitis
Have an active infection requiring systemic therapy
Have had prior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-L1, anti-PD-L2, or anticytotoxic T lymphocyte-associated antigen-4 antibody
Moderate or severe cardiovascular disease
Have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
Have received a live vaccine within 30 days before the first dose of study treatment

About this study

Official title: A Phase 1a/1b Study of CXCR4 Peptide Antagonist (LY2510924) Administered in Combination With the Anti-PD-L1 Antibody, Durvalumab (MEDI4736), in Advanced Refractory Solid Tumors

Conditions: Solid Tumor
Being tested: LY2510924, Durvalumab
Keywords: immuno-oncology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2510924Drug
Administered SQ
DurvalumabDrug
Administered IV

Study groups in NCT02737072
Study group	Role	What they receive
20 mg LY2510924 + 1500 mg Durvalumab	Experimental	20 milligrams (mg) LY2510924 given subcutaneously (SQ) once daily in combination with 1500 mg durvalumab given intravenously (IV) on Day 1 of each cycle (28 days). Receives: Drug: LY2510924; Drug: Durvalumab
30 mg LY2510924 + 1500 mg Durvalumab	Experimental	30 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days). Receives: Drug: LY2510924; Drug: Durvalumab
40 mg LY2510924 + 1500 mg Durvalumab	Experimental	40 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days). Receives: Drug: LY2510924; Drug: Durvalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
DLT is defined as 1 of the following adverse events(AE) reported during the Phase 1a DLT observation period,if considered to be definitely,probably,or possibly related to either study regimen by the investigator;and fulfills any 1 of the following criterion using(NCI)CTCAE version(v)4.03:Grade4 immune-related AE,Grade4 non-laboratory AE,any CTCAE Grade ≥3 QT prolongation AE,≥Grade3 colitis or noninfectious pneumonitis irrespective of duration,Grade3 immune-related AE(excluding colitis,QT prolongation,or pneumonitis) that does not downgrade to Grade2 within 3 days after onset of event despite optimal medical management including systemic corticosteroids,or does not downgrade to ≤Grade 1 or baseline within 14 days,Grade2 pneumonitis that does not resolve to ≤Grade 1 within 3 days of the initiation of maximal supportive care,including corticosteroid therapy,Grade3 toxicity lasting an extended time despite optimal supportive care and there were also laboratory abnormalities criterion.
Measured: Cycle 1 (28 Days)
Maximum Tolerated Dose (MTD) of LY2510924
MTD was determined after the evaluation of Phase 1a portion of the trial. For Phase 1a, any DLT-equivalent toxicities observed in Cycle 2 and beyond were also be considered in dose escalation and determining MTD/recommended Phase 2 dose. See outcome measure number 1 for the DLT criterion.
Measured: Cycle 1 (28 Days)

Secondary outcomes (4)

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC [0-∞]) of LY2510924 When Co-Administered With Durvalumab
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC [0-∞]) of LY2510924 when Co-Administered with Durvalumab
Measured: Cycle 1 Day 1: Predose, 0.5, 2, 4, 6, 8, 24-30 hours; Day 15: Predose, 0.5, 2, 4, 6, 8 hours
Number of Participants With Anti-Durvalumab Antibodies When Administered in Combination With LY2510924
Number of participants with treatment-emergent positive Anti-Durvalumab antibodies was summarized by treatment group.
Measured: Predose Cycle 1 Day 1 through 90 Day Post Treatment Follow Up (Up To 12 Months)
Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Best overall response of CR or PR was defined using RECIST v 1.1 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was defined as ≥30% decrease in sum of diameter(SOD) of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100.
Measured: Baseline through Measured Progressive Disease or Death (Up To 12 Months)
Percentage of Participants With CR, PR, or Stable Disease (SD) (Disease Control Rate [DCR])
DCR: percentage of participants with CR, PR, or SD using RECIST v 1.1 criteria. CR: disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR: ≥30% decrease in sum of diameter (SOD) of target lesions taking as reference baseline sum diameter. PD: ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference smallest sum of longest diameters recorded since treatment started and an absolute increase in sum diameter ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor increase to qualify for PD. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR+SD/total number of participants)*100.
Measured: Baseline through Measured Progressive Disease (Up To 12 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201625 Sep 2017

First posted13 Apr 2016 (estimated)
Study startSep 2016
Primary completion25 Sep 2017
Study completion25 Sep 2017

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: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02737072
Sponsor's protocol ID: 16387
Other IDs: I2V-MC-CXAD
Status last verified: Jun 2019
First submitted: 8 Apr 2016
Last updated: 12 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1a/1b Study of CXCR4 Peptide Antagonist (LY2510924) Administered in Combination With the Anti-PD-L1 Antibody, Durvalumab (MEDI4736), in Advanced Refractory Solid Tumors
ClinicalTrials.gov ID: NCT02737072
Acronym / sponsor ID: 16387
Conditions: Solid Tumor
Keywords: immuno-oncology
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 9 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: AstraZeneca
Study start: Sep 2016
Primary completion: 25 Sep 2017 (actual)
Study completion: 25 Sep 2017 (actual)
First posted: 13 Apr 2016 (estimated)
Results: Posted 12 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
20 mg LY2510924 + 1500 mg Durvalumab	Experimental	Drug: LY2510924, Drug: Durvalumab20 milligrams (mg) LY2510924 given subcutaneously (SQ) once daily in combination with 1500 mg durvalumab given intravenously (IV) on Day 1 of each cycle (28 days).
30 mg LY2510924 + 1500 mg Durvalumab	Experimental	Drug: LY2510924, Drug: Durvalumab30 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days).
40 mg LY2510924 + 1500 mg Durvalumab	Experimental	Drug: LY2510924, Drug: Durvalumab40 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Phase 1a: Have histologic or cytologic confirmation of advanced solid tumor
Have at least 1 measurable lesion assessable using standard techniques by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Have adequate organ function
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Have provided tissue from a newly obtained core or excisional biopsy of a tumor lesion or a recent biopsy defined by ≤3 years since last documented progression of disease

Key exclusion criteria (8 listed)

Have a serious concomitant systemic disorder including human immunodeficiency virus (HIV), active hepatitis B virus (HBV), active HCV, active autoimmune disorder or disease requiring high dose of steroids
Have had prior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-L1, anti-PD-L2, or anticytotoxic T lymphocyte-associated antigen-4 antibody
Moderate or severe cardiovascular disease
Have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
Have received a live vaccine within 30 days before the first dose of study treatment

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
LY2510924Administered SQ	Drug	20 mg LY2510924 + 1500 mg Durvalumab, 30 mg LY2510924 + 1500 mg Durvalumab, 40 mg LY2510924 + 1500 mg Durvalumab
DurvalumabAdministered IV	Drug	20 mg LY2510924 + 1500 mg Durvalumab, 30 mg LY2510924 + 1500 mg Durvalumab, 40 mg LY2510924 + 1500 mg Durvalumab

Primary outcome

Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Time frame: Cycle 1 (28 Days)
DLT is defined as 1 of the following adverse events(AE) reported during the Phase 1a DLT observation period,if considered to be definitely,probably,or possibly related to either study regimen by the investigator;and fulfills any 1 of the following criterion using(NCI)CTCAE version(v)4.03:Grade4 immune-related AE,Grade4 non-laboratory AE,any CTCAE Grade ≥3 QT prolongation AE,≥Grade3 colitis or noninfectious pneumonitis irrespective of duration,Grade3 immune-related AE(excluding colitis,QT prolongation,or pneumonitis) that does not downgrade to Grade2 within 3 days after onset of event despite optimal medical management including systemic corticosteroids,or does not downgrade to ≤Grade 1 or baseline within 14 days,Grade2 pneumonitis that does not resolve to ≤Grade 1 within 3 days of the initiation of maximal supportive care,including corticosteroid therapy,Grade3 toxicity lasting an extended time despite optimal supportive care and there were also laboratory abnormalities criterion.
Maximum Tolerated Dose (MTD) of LY2510924
Time frame: Cycle 1 (28 Days)
MTD was determined after the evaluation of Phase 1a portion of the trial. For Phase 1a, any DLT-equivalent toxicities observed in Cycle 2 and beyond were also be considered in dose escalation and determining MTD/recommended Phase 2 dose. See outcome measure number 1 for the DLT criterion.

4 secondary outcomes

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC [0-∞]) of LY2510924 When Co-Administered With Durvalumab
Time frame: Cycle 1 Day 1: Predose, 0.5, 2, 4, 6, 8, 24-30 hours; Day 15: Predose, 0.5, 2, 4, 6, 8 hours
Number of Participants With Anti-Durvalumab Antibodies When Administered in Combination With LY2510924
Time frame: Predose Cycle 1 Day 1 through 90 Day Post Treatment Follow Up (Up To 12 Months)
Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Time frame: Baseline through Measured Progressive Disease or Death (Up To 12 Months)
Percentage of Participants With CR, PR, or Stable Disease (SD) (Disease Control Rate [DCR])
Time frame: Baseline through Measured Progressive Disease (Up To 12 Months)

Results and safety

Results posted to the registry on 12 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
20 mg LY2510924 + 1500 mg Durvalumab	3	3
30 mg LY2510924 + 1500 mg Durvalumab	3	3
40 mg LY2510924 + 1500 mg Durvalumab	3	3

Primary outcome: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)

Time frame: Cycle 1 (28 Days). Count of participants. Unit: Participants

Measure	20 mg LY2510924 + 1500 mg Durvalumab n = 3	30 mg LY2510924 + 1500 mg Durvalumab n = 3	40 mg LY2510924 + 1500 mg Durvalumab n = 3
Value	0	0	0

Population analysed: All participants who received at least one of dose of study drug.

Primary outcome: Maximum Tolerated Dose (MTD) of LY2510924

Time frame: Cycle 1 (28 Days). Number. Unit: milligram (mg)

Measure	All Phase 1a Participants n = 3
Value	40

Population analysed: All phase 1a participants who received at least one dose of study drug.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up To 14 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
20 mg LY2510924 + 1500 mg Durvalumab	0 of 3 (0%)	3 of 3 (100%)	2 of 3
30 mg LY2510924 + 1500 mg Durvalumab	1 of 3 (33.3%)	3 of 3 (100%)	3 of 3
40 mg LY2510924 + 1500 mg Durvalumab	1 of 3 (33.3%)	3 of 3 (100%)	1 of 3

Limitations and caveats (from the sponsor): The study was terminated after the Phase 1a part was complete.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Click here for more information about this study: A Study of LY2510924 and Durvalumab in Participants With Solid TumorsLink provided by the sponsor.

Related trials for Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2510924 and Durvalumab in people with Solid Tumor, run by Eli Lilly and Company.

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 6 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: stopped early, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

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 12 Aug 2019). 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 Who Experienced Dose-Limiting Toxicities (DLTs) (time frame: Cycle 1 (28 Days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02737072.

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 12 Aug 2019.