Phase 1
N=14
A Study of IMC-TR1 in Participants With Advanced Solid Tumors
Neoplasms · Tumor
Bottom Line
View on ClinicalTrials.gov: NCT01646203 ↗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
| Outcome | Result | p-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
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.