A Study of Intratumoral IMO-2125 in Patients With Refractory Solid Tumors

NCT ID: NCT03052205

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-09
• Study Completion Date: 2019-10-04

Brief Summary

This is a Phase 1b study that incorporates dose expansion cohorts to further evaluate promising clinical or biological activity.

Conditions

Refractory Solid Tumors; Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMO-2125 at escalating dose levels

IMO-2125 at escalating dose levels by intratumoral injection

Group Type: EXPERIMENTAL

IMO-2125

Intervention Type: DRUG

IMO-2125 will be administered by intratumoral injection on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle.

Interventions

IMO-2125

IMO-2125 will be administered by intratumoral injection on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients must have histologically or cytologically confirmed diagnosis of cancer not amenable to curative therapy.

2. Patients who have a diagnosis for which a PD-(L)-1 inhibitor has been approved must have previously received treatment with one of these therapies.

a. Melanoma Dose Expansion: Patients must have histologically confirmed metastatic melanoma (ocular melanoma not included) which has progressed on or after treatment with a PD-(L)1 inhibitor.

3. a) Dose Evaluation Portion: Patients should have at least one lesion accessible for intratumoral injection and biopsy.

b) Melanoma Expansion Cohort: Patients must have at least one target lesion by Response Evaluation Criteria for Solid Tumors (RECIST v1.1), with at least one lesion accessible for intratumoral injection. Tumor biopsies are not required in the expansion cohort.

4. Patients must be 18 years of age or older.

5. Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.

6. Patients must meet the following laboratory criteria:

1. Absolute neutrophil count ANC ≥1.5 x 109/L (≥1500/mm3)

2. Platelet count ≥75 x 109/L (≥75,000/mm3)

3. Hemoglobin ≥8.0 g/dL (≥4.96 mmol/L)

4. Serum creatinine ≤1.5 x ULN or calculated 24-hour creatinine clearance ≥60 mL/minute

5. Aspartate aminotransferase (AST) ≤2.5 x ULN; ALT ≤2.5 x ULN or AST/ALT <5 x ULN if liver involvement

6. Total bilirubin ≤1.5 x ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin <3 mg/dL (51.3 μmol/L)

7. Women of childbearing potential and men must agree to use effective contraceptive methods from Screening throughout the study treatment period and until at least 4 weeks after the last dose of study drug.

8. Patients must be willing and able to provide signed informed consent and comply with the study protocol.

Exclusion Criteria

1. Patients who have received prior therapy with a TLR agonist Patients who have received experimental vaccines or immune therapies other than PD-(L)1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors (e.g., Imlygic®) should be discussed with the Medical Monitor to confirm eligibility.

Note: (prior treatment with a topical TLR agonist (e.g. imiquimod) is permitted).

2. Patients who have received treatment with IFN-α within the previous 6 months prior to enrollment.

3. Patients with known hypersensitivity to any oligodeoxynucleotide that cannot be adequately managed with appropriate prophylaxis; e.g. steroids.

4. Patients with active autoimmune disease requiring disease-modifying therapy.

5. Patients requiring concurrent systemic steroid therapy higher than physiologic dosage (>10mg/day of prednisone or equivalent).

6. Patients with another primary malignancy that has not been in remission for at least 3 years, unless approved by the Idera Medical Monitor. The following are exempt from the 3-year limit: non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic).

7. Patients with active infections requiring systemic treatment.

8. Patients who are known to be hepatitis B surface antigen positive.

9. Patients with a known diagnosis of human immunodeficiency virus (HIV) infection.

10. Women who are pregnant or breastfeeding.

11. Patients with known central nervous system, meningeal, or epidural disease. Patients with stable brain metastases following definitive local treatment are eligible if steroid requirement is <10 mg/day of prednisone (or equivalent).

12. Patients with impaired cardiac function or clinically significant cardiac disease:

1. New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant ventricular arrhythmia, congestive heart failure, or cardiomyopathy

2. Unstable angina pectoris ≤6 months prior to study participation

3. Acute myocardial infarction ≤6 months prior to study participation

4. Other clinically significant heart disease (i.e., Grade ≥3 hypertension, history of labile hypertension, or poor compliance with an anti-hypertensive regimen)

13. Have not recovered (to baseline or Grade ≤1) from toxicity associated with prior treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Idera Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Idera Medical Director

Role: STUDY_DIRECTOR

Idera Pharmaceuticals, Inc.

Locations

Scottsdale Healthcare Hospitals DBA Honor Health

Scottsdale, Arizona, United States

The University of Arizona Cancer Center

Tucson, Arizona, United States

University of California San Francisco (UCSF)

San Francisco, California, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

St. Luke's Hospital

Easton, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

Rambam Medical Center

Haifa, , Israel

Hadassah Medical Center

Jerusalem, , Israel

Rabin Medical Center Beilinson Campus

Petah Tikva, , Israel

The Ella Lemelbaum Institute for Immuno-Oncology

Ramat Gan, , Israel

Countries

United States; Israel

Other Identifiers

2125-RST-101

Identifier Type: -

Identifier Source: org_study_id