A Study of LY2510924 and Durvalumab in Participants With Solid Tumors

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-09-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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20 mg LY2510924 + 1500 mg Durvalumab

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).

Group Type EXPERIMENTAL

LY2510924

Intervention Type DRUG

Administered SQ

Durvalumab

Intervention Type DRUG

Administered IV

30 mg LY2510924 + 1500 mg Durvalumab

30 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days).

Group Type EXPERIMENTAL

LY2510924

Intervention Type DRUG

Administered SQ

Durvalumab

Intervention Type DRUG

Administered IV

40 mg LY2510924 + 1500 mg Durvalumab

40 mg LY2510924 given SQ once daily in combination with 1500 mg durvalumab given IV on Day 1 of each cycle (28 days).

Group Type EXPERIMENTAL

LY2510924

Intervention Type DRUG

Administered SQ

Durvalumab

Intervention Type DRUG

Administered IV

Interventions

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LY2510924

Administered SQ

Intervention Type DRUG

Durvalumab

Administered IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No