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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Neoplasms Tumor

Study Design

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Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IMC-TR1

Part A - Dose Escalation:

Cohort 1A: 1.25 mg/kg, intravenously (IV), every 2 weeks of the 6-week treatment cycle

Cohorts 1B-9: Dose Escalation from 12.5 mg to 1600 mg (flat dose), intravenously (IV), every 2 weeks of the 6-week treatment cycles

Cohorts 10-12: Dose escalation from 800 mg to 1600 mg (flat dose), intravenously (IV), weekly during the 6-week treatment cycles

Part B - Disease Specific Cohort Expansion:

Participants will be enrolled into each of three tumor-specific cohort expansions. Participants will be treated with recommended Phase 2 dose.

Group Type EXPERIMENTAL

IMC-TR1

Intervention Type BIOLOGICAL

Administered intravenously

Interventions

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IMC-TR1

Administered intravenously

Intervention Type BIOLOGICAL

Other Intervention Names

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LY3022859

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No