Patient case: 63-year-old female with aortic aneurysm; genetic feature: ACTA2

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

Summary: 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.

Detailed description: This is the first-in-human Phase 1 study of IMC-TR1.

Eligibility: Inclusion Criteria:
  -  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
  Exclusion Criteria:
  -  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

Relevance to patient case: not relevant