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Phase 1 Study of Anti-TGFβRII Monoclonal Antibody IMC-TR1 (LY3022859) in Patients With Advanced Solid Tumors That Have Failed Standard Therapy or for Which No Standard is Available


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasms, Tumor

Thank you

Trial Information

Phase 1 Study of Anti-TGFβRII Monoclonal Antibody IMC-TR1 (LY3022859) in Patients With Advanced Solid Tumors That Have Failed Standard Therapy or for Which No Standard is Available


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


Inclusion Criteria:



- Part A and Part B: Patients 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: Patients must have histological or cytological evidence of a solid
tumor which is advanced and/or metastatic

- Part B only: Patient 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: Patients may have measurable or nonmeasurable disease

- Part B: Patients 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 QTc interval of > 500 msec on screening ECG

- Have other known serious pre-existing medical conditions

- Have received prior investigational therapy targeting 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 patient

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended phase 2 dose of IMC-TR1

Outcome Time Frame:

Baseline to study completion (Approximately 18 Months)

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

14549

NCT ID:

NCT01646203

Start Date:

July 2012

Completion Date:

February 2015

Related Keywords:

  • Neoplasms
  • Tumor
  • Advanced Solid Tumors
  • Neoplasms

Name

Location

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.Memphis, Tennessee  38138
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.Bedford, Texas  76022