A Study of IMC-TR1 in Participants With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Neoplasms, Tumor

In brief

A study to evaluate the safety and tolerability of anti-TGFβRII monoclonal antibody (IMC-TR1) in participants with advanced solid tumors, as well as gather evidence of anti-tumor activity.

Key facts

Study ID

NCT01646203

Run by

Eli Lilly and Company

People needed

14

Starts

2012-07-01

Expected to finish

2014-10-01

Last updated by the study team

2019-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Part A and Part B: Participants must be appropriate candidates for experimental therapy, with a solid tumor that has failed standard therapy or for which no standard therapy is available, and evidence of progressive disease
• Part A only: Participants must have histological or cytological evidence of a solid tumor which is advanced and/or metastatic
• Part B only: Participants who have failed first-line therapy/standard of care and have histological or cytological evidence of a cancer type for which evidence of activity was observed during Part A or for which preclinical evidence of potential activity has been observed
• Have the presence of measurable or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)
• Part A only: Participants may have measurable or nonmeasurable disease
• Part B: Participants must have measurable disease
• Have adequate organ function including: Hematologic, Hepatic, Albumin, Coagulation and Renal function
• Have a performance status of ≤ 1 on the Eastern Cooperative Oncology Group (ECOG) scale
• Have discontinued previous treatments for cancer and recovered from the acute effects of therapy
• Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug
• Females with child bearing potential must have had a negative serum pregnancy test and must not be breastfeeding
• Have an estimated life expectancy that is > 3 months

You may not qualify if…

• Have clinically significant cardiac disease, including:
• Myocardial infarction within 6 months prior to study entry, unstable angina pectoris, congestive heart failure, or uncontrolled hypertension
• Major electrocardiogram (ECG) abnormalities
• Major abnormalities documented by echocardiography with Doppler
• Have known predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress
• Have Corrected QT Interval (QTc interval) of > 500 msec on screening ECG
• Have other known serious pre-existing medical conditions
• Have received prior investigational therapy targeting Transforming growth factor beta (TGFβ) or its receptors
• Have a known sensitivity to monoclonal antibodies or other therapeutic proteins, to agents of similar biologic composition as IMC-TR1
• Have a high risk of gastrointestinal bleeding, active inflammatory bowel disease, or chronic steroid use
• Are currently using or has received a systemic thrombolytic agent within 28 days prior to enrollment
• Are receiving:
• full-dose warfarin
• intravenous heparin or low-molecular-weight heparin
• chronic daily treatment with aspirin at a dose greater than 325 mg per day or nonsteroidal anti-inflammatory medications known to inhibit platelet function
• Have evidence of retinal disease or are a monocular participant
• Have received a solid organ transplant, bone marrow transplant or stem cell transplant
• Have symptomatic central nervous system (CNS) malignancy or untreated metastasis
• Have acute or chronic leukemia
• Have a known active fungal, bacterial, and/or viral infection including human immunodeficiency virus or viral hepatitis requiring treatment
• Has a positive fecal occult blood test within 14 days prior to enrollment

Where it is running

• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician — Nashville, Tennessee, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician — Houston, Texas, United States
• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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