Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TRC105 · 1 trial · 1 indication
This outcome will report the number of patients who experienced a dose-limiting Toxicity (DLT) in Phase I Cohort 1, Phase I Cohort 2, and Phase I Cohort -1. A DLT was defined as: 1. A grade 3 or 4 non-hematologic toxicity except anorexia, alopecia, nausea (which is not refractory to antiemetics), fatigue, and fever without neutropenia; 2. Failure to recover to baseline (except alopecia) after delaying the next dose by more than 14 days; 3. Grade 3 or 4 neutropenia complicated by fever \>38.5°C or infection, or grade 4 neutropenia of ≥7 days duration; or 4. Grade 4 thrombocytopenia, or grade 3 thrombocytopenia complicated by hemorrhage. The maximum tolerated dose (MTD) is defined as the highest dose at which 0 out of the first 3 or 1 out of a total of 6 patients experience DLT during the first cycle of therapy; this dose level will be the recommended phase 2 dose (RP2D) in the Phase II Group.
| Arm | Type | Description |
|---|---|---|
| Phase I Cohort 1 | EXPERIMENTAL | Letrozole 2.5 mg PO daily until surgery, everolimus 5 mg PO daily for 24 weeks, and TRC105 15 mg/kg IV q 2 weeks for 24 weeks |
| Phase I Cohort 2 | EXPERIMENTAL | Letrozole 2.5 mg PO daily until surgery, everolimus 10 mg PO daily for 24 weeks, and TRC105 15 mg/kg IV q 2 weeks for 24 weeks |
| Phase I Cohort -1 | EXPERIMENTAL | Letrozole 2.5 mg PO daily until surgery, everolimus 5 mg PO daily for 24 weeks, and TRC105 10 mg/kg IV q 2 weeks for 24 weeks |
| Phase II | EXPERIMENTAL | Letrozole 2.5 mg PO daily until surgery, everolimus 5 or 10 mg PO daily for 24 weeks, and TRC105 15 or 10 mg/kg IV q 2 weeks for 24 weeks. Dose and regimen to be determined based on data from the phase I component. |
| Name | Type | Description |
|---|---|---|
| Letrozole | DRUG | A dose of 2.5 mg of letrozole will be given orally once each day until one day before surgery. This drug is commercially available and is not provided by the study. |
| Everolimus | DRUG | The dose of everolimus will be escalated from 5 mg to 10 mg daily depending upon the cohort in Phase I. It is administered as an oral pill to be taken once daily up until four weeks prior to surgery. |
| TRC105 | DRUG | The dose for TRC105 is either 15 or 10 mg/kg to be given intravenously every two weeks and continued until four weeks prior to surgery. |
Inclusion Criteria: * Recent diagnosis of hormone receptor positive and HER2 negative breast cancer. * Stage 2 and 3 hormone receptor positive and HER2 negative breast cancer (stage T2-4 but not inflammatory, N0-2, M0). * Histological grade I, II or III according to the modified Bloom Richardson sc...
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TRC105 is an investigational small molecule being studied for the treatment of breast cancer, specifically in postmenopausal women with hormone-receptor positive and HER2 negative breast cancer. It is being evaluated in combination with letrozole and everolimus. TRC105 is not approved and remains in clinical development.
TRC105 is a small molecule that targets endoglin, a protein involved in tumor angiogenesis. By inhibiting endoglin, TRC105 aims to disrupt the blood supply to tumors, potentially slowing cancer growth. This mechanism is being explored in the context of hormone-receptor positive, HER2 negative breast cancer.
TRC105 is being developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the safety and efficacy of TRC105 in breast cancer.
TRC105 is in Phase 1 clinical development. A Phase 1 trial has been completed, which enrolled 15 participants. The drug is investigational and has not received FDA approval. Its safety and efficacy are still being evaluated in early-stage clinical research.
TRC105 has one completed clinical trial, identified as NCT02520063. This Phase 1 study evaluated the combination of letrozole, everolimus, and TRC105 in postmenopausal women with hormone-receptor positive and HER2 negative breast cancer. The trial was conducted in the United States and enrolled 15 female participants aged 19 years and older.
TRC105 is also known as carotuximab. It is an investigational drug being studied for breast cancer. The clinical trial NCT02520063 refers to TRC105, and carotuximab is the alternative name for the same compound. Both names refer to the same investigational therapy.