A Study of LY2510924 and Durvalumab in Participants With Solid Tumors

Lilly

Status and phase: Terminated; Phase 1

Conditions: Solid Tumor

Treatments: Drug: LY2510924; Drug: Durvalumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02737072

16387

I2V-MC-CXAD (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

20 mg LY2510924 + 1500 mg Durvalumab

Experimental group

Description:

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).

Treatment:

Drug: LY2510924

Drug: Durvalumab

30 mg LY2510924 + 1500 mg Durvalumab

Experimental group

Description:

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

Treatment:

Drug: LY2510924

Drug: Durvalumab

40 mg LY2510924 + 1500 mg Durvalumab

Experimental group

Description:

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

Treatment:

Drug: LY2510924

Drug: Durvalumab