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Trial record 2 of 4 for:    IMO-2125

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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Idera Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Idera Pharmaceuticals, Inc. Identifier:
First received: February 6, 2017
Last updated: September 19, 2017
Last verified: September 2017
This is a Phase 1b study that incorporates dose expansion cohorts to further evaluate promising clinical or biological activity.

Condition Intervention Phase
Refractory Solid Tumors Drug: IMO-2125 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Study of Intratumoral IMO-2125 in Patients With Refractory Solid Tumors

Resource links provided by NLM:

Further study details as provided by Idera Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Number of patients with treatment-related adverse events as assessed by CTCAE to determine the recommended Phase 2 dose (RP2D). [ Time Frame: 51 weeks of treatment ]

Estimated Enrollment: 40
Actual Study Start Date: June 9, 2017
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMO-2125 at escalating dose levels
IMO-2125 at escalating dose levels by intratumoral injection
Drug: 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed diagnosis of cancer not amenable to curative therapy.
  • Patients who have a diagnosis for which a PD(L)-1 inhibitor is FDA approved must have previously received treatment with one of these therapies.
  • Patients must have a disease that is measurable by RECIST v1.1 and at least 2 tumors that are accessible to biopsy.
  • Patients must be 18 years of age or older.
  • Patients must have ECOG Performance Status ≤2.
  • Patients must meet the following laboratory criteria:

    1. ANC ≥1.5 x 109/L (≥1500/mm3)
    2. Platelet count ≥100 x 109/L (≥100,000/mm3)
    3. Hemoglobin ≥8.0 g/dL (≥4.96 mmol/L)
    4. Serum creatinine ≤1.5 x ULN or 24-hour creatinine clearance ≥60 mL/minute
    5. AST ≤2.5 x ULN; ALT ≤2.5 x ULN or AST/ALT <5 x ULN if liver involvement
    6. Serum 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)

Exclusion Criteria:

  • Patients who have received prior therapy with a TLR agonist (prior treatment with a topical TLR agonist (e.g. imiquimod) is permitted).
  • Patients who have received treatment with IFN-α within the previous 6 months prior to enrollment.
  • Patients with known hypersensitivity to any oligodeoxynucleotide that cannot be adequately managed with appropriate prophylaxis.
  • Patients with active autoimmune disease requiring disease-modifying therapy.
  • Patients requiring concurrent systemic steroid therapy higher than physiologic dosage (7.5 mg/day of prednisone or equivalent).
  • Patients with another primary malignancy that has not been in remission for at least 3 years. 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).
  • Patients with active infections requiring systemic treatment.
  • Patients who are known to be hepatitis B surface antigen positive.
  • Patients with a known diagnosis of human immunodeficiency virus (HIV) infection.
  • Women who are pregnant or breastfeeding.
  • 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 <7.5 mg/day of prednisone (or equivalent).
  • Patients with impaired cardiac function or clinically significant cardiac disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT03052205

Contact: Idera Study Monitor 877-888-6550 ext 2

United States, Arizona
Scottsdale Healthcare Hospitals DBA Honor Health Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer, RN    480-323-1339   
Principal Investigator: Erkut Borazanci, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: AskRPCI    1-800-275-7724      
Principal Investigator: Igor Puzanov, MD, MSCI, FACP         
United States, Pennsylvania
St. Luke's Hospital Recruiting
Easton, Pennsylvania, United States, 18045
Contact: Jillian Timer, RN, BSN    484-503-4156   
Principal Investigator: Sanjiv Agarwala, MD         
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Robert Ferris, MD, PhD         
Sponsors and Collaborators
Idera Pharmaceuticals, Inc.
Study Director: Idera Medical Director Idera Pharmaceuticals, Inc.
  More Information

Responsible Party: Idera Pharmaceuticals, Inc. Identifier: NCT03052205     History of Changes
Other Study ID Numbers: 2125-RST-101
Study First Received: February 6, 2017
Last Updated: September 19, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No processed this record on September 21, 2017