A Study of IMC-TR1 in Participants With Advanced Solid Tumors
Condition: Neoplasms; Tumor
MeSH terms: Neoplasms
Intervention: IMC-TR1
Intervention description: Administered intravenously
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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.
    

Eligibility criteria:

        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