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Phase 1 N=14 Treatment

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

Neoplasms · Tumor

Enrolled (actual)
14
Serious AEs
42.9%
Results posted
Jan 2019
Primary outcome: Primary: Number of Participants With Dose-Limiting Toxicities (DLTs) — 2; 0; 2 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
IMC-TR1 (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Eli Lilly and Company
Primary completion
Oct 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Dose-Limiting Toxicities (DLTs)
2; 0; 2
SECONDARY
Maximum Tolerated Dose (MTD) of IMC-TR1
NA
SECONDARY
Maximum Tolerated Dose (MTD) of IMC-TR1 (1.25 mg/kg LY3022859 ) for Participants Receiving a Weight-Based Dose
NA
SECONDARY
Number of Dose-Limiting Toxicities (DLTs)
2; 0; 2
SECONDARY
Immunogenicity - Development of Antibodies Against IMC-TR1
SECONDARY
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (Antitumor Activity of IMC-TR1 as Monotherapy, Assessed Via Tumor Measurement by Response Evaluation Criteria in Solid Tumors, Version 1.1)
0; 0; 0
SECONDARY
Pharmacokinetics (PK) - Area Under the Concentration-time Curve (AUC[0-tlast]) and AUCτ of IMC-TR1
28.5; 60.2; 60.7
SECONDARY
Pharmacokinetics - Maximum Concentration (Cmax) of IMC-TR1
4.34; 5.10; 3.52; 5.01
SECONDARY
Pharmacokinetics - Minimum Concentration (Cmin) of IMC-TR1
NA; NA

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01646203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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