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

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Status and phase

Completed
Phase 1

Conditions

Neoplasms
Tumor

Treatments

Biological: IMC-TR1

Study type

Interventional

Funder types

Industry

Identifiers

NCT01646203
I5I-IE-JTCA (Other Identifier)
14549

Details and patient eligibility

About

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.

Full description

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

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

14 participants in 1 patient group

IMC-TR1
Experimental group
Description:
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.
Treatment:
Biological: IMC-TR1

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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