Clinical trial · Interventional
A Study of IMC-TR1 in Participants With Advanced Solid Tumors
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
NCT01646203CI-TRIAL-00036633completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMC-TR1 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMC-TR1
- 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.
- interventionNames
- Biological: IMC-TR1
Primary outcomes (1)
- measure
- Number of Participants With Dose-Limiting Toxicities (DLTs)
- timeFrame
- First Dose Up to 6 Weeks
- description
- A DLT was defined as an AE occurring during Cycle 1(first 6 weeks of treatment) that was considered at least possibly related to study drug, was considered dose-dependent, and fulfilled a criteria selected (using the National Cancer Institute Common Terminology Criteria for Adverse Events,version 4.0 \[NCI-CTCAE v 4.0\] \[NCI 2009\]):Grade(Gr)≥3 nonhematological toxicity,Gr4 thrombocytopenia lasting at least 5 days and/or complicated with bleeding,Gr≥3 febrile neutropenia(ntr),Gr4 ntr of \>5 days' duration,increase(incr)of at least 1 gr from a preexisting Gr1 valvular insufficiency or any new Gr≥2 valvular toxicity,left ventricular(vtr) ejection fraction decrease of 10% in absolute value or 16% in relative value,incr in right vtr systolic pressure dysfunction from mild to moderate(mod) or from mod to severe,incr in left atrial or ventricular chamber size of ≥2 cm and ≥1cm respectively,any other life-threatening toxicity,significant morphologic on cardiac echocardiogram,any major ocular.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTolcher AW, Berlin JD, Cosaert J, Kauh J, Chan E, Piha-Paul SA, Amaya A, Tang S, Driscoll K, Kimbung R, Kambhampati SR, Gueorguieva I, Hong DS. A phase 1 study of anti-TGFbeta receptor type-II monoclonal antibody LY3022859 in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2017 Apr;79(4):673-680. doi: 10.1007/s00280-017-3245-5. Epub 2017 Mar 9. PMID 28280971