a study of imc-tr1 in participants with advanced solid tumors

Conditions: Neoplasms; Tumor

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.

this is the first-in-human phase 1 study of imc-tr1.

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

Keywords: advanced solid tumors