Overview
No overview information available.
Indication
Investigated for use/treatment in solid tumors.
Associated Conditions
No associated conditions information available.
Research Report
An In-Depth Analysis of Carotuximab (DB06322): Mechanism, Clinical Development, and Therapeutic Potential
Executive Summary
Carotuximab is an investigational chimeric monoclonal antibody that represents a novel therapeutic approach in oncology by targeting endoglin (CD105), a co-receptor in the transforming growth factor-beta (TGF-β) signaling superfamily critical for angiogenesis. This report provides a comprehensive analysis of Carotuximab's molecular profile, its intricate mechanism of action, its extensive and varied clinical development history, and its future therapeutic potential. Initially developed under the code name TRC-105, Carotuximab's journey is a compelling narrative of scientific promise, significant clinical setbacks, and recent, potentially transformative, success.
The drug's mechanism is multifaceted, extending beyond simple anti-angiogenesis. By binding to endoglin, which is highly expressed on proliferating tumor endothelial cells, Carotuximab inhibits the pro-angiogenic Smad1/5/8 signaling pathway. Furthermore, it demonstrates crucial crosstalk with the vascular endothelial growth factor (VEGF) pathway, potentiating the effects of VEGF inhibitors and providing a strong rationale for combination therapies. Its IgG1 backbone also enables immunomodulatory functions, including antibody-dependent cell-mediated cytotoxicity (ADCC).
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/09/09 | Phase 2 | Recruiting | Edwin Posadas, MD | ||
2022/06/02 | Phase 1 | Recruiting | Karen Reckamp, MD, MS | ||
2018/12/19 | Phase 1 | Completed | Tracon Pharmaceuticals Inc. | ||
2018/02/01 | Phase 2 | Completed | |||
2017/06/08 | Phase 1 | Completed | Tracon Pharmaceuticals Inc. | ||
2016/01/27 | Phase 2 | Terminated | Tracon Pharmaceuticals Inc. | ||
2015/09/25 | Phase 1 | Completed | Tracon Pharmaceuticals Inc. | ||
2015/08/11 | Phase 1 | Active, not recruiting | |||
2015/04/29 | Phase 1 | Completed | |||
2015/02/03 | N/A | NO_LONGER_AVAILABLE | Tracon Pharmaceuticals Inc. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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