Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KTN3379 · 3 trials · 3 indications
Reduction in pErbB3 levels
Continued assessment of safety
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | Treatment with KTN3379 in HPV positive head and neck cancer patients |
| B | EXPERIMENTAL | Treatment with KTN3379 in HPV negative head and neck cancer patients |
| Combination of Vemurafenib and KTN3379 | EXPERIMENTAL | Vemurafenib 960 mg po bid KTN3379 1000 mg IV q2weeks |
| KTN3379 | EXPERIMENTAL | KTN3379 |
| Part II, Arm A | EXPERIMENTAL | Combination of KTN3379 and cetuximab |
| Part II, Arm B | EXPERIMENTAL | Combination of KTN3379 and erlotinib |
| Part II, Arm C | EXPERIMENTAL | Combination of KTN3379 and vemurafenib |
| Part II, Arm D | EXPERIMENTAL | Combination of KTN3379 and trastuzumab |
| Name | Type | Description |
|---|---|---|
| KTN3379 | BIOLOGICAL | - |
| vemurafenib | DRUG | 960 mg po bid |
Inclusion Criteria: 1. Histologically or cytologically confirmed primary, untreated SCCHN including variants. Patients must be candidates for surgical resection. Primary tumors of oral cavity, oropharynx, hypopharnyx or larynx are included. 2. Written informed consent and any locally required autho...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
KTN3379 is an investigational monoclonal antibody being developed by Celldex Therapeutics, Inc. for the treatment of advanced cancer. It has been studied in squamous cell carcinoma of the head and neck and in thyroid cancer. It is a Phase 1 agent and has not been approved for commercial use.
KTN3379 targets ErbB3, a protein receptor. By binding to ErbB3, the antibody is designed to interfere with signaling pathways that support tumor growth. ErbB3 targeting places KTN3379 in the broader class of receptor tyrosine kinase directed cancer therapies.
Celldex Therapeutics, Inc. is the developer of KTN3379. The company trades on the Nasdaq under the ticker symbol CLDX. Celldex sponsored the clinical studies of KTN3379, including the Phase 1 trial in advanced tumors and the two Phase 1 studies in head and neck cancer and thyroid cancer.
KTN3379 is in Phase 1 development. It is an investigational agent and has not been approved by the FDA. All three of its recorded clinical trials are Phase 1 studies, and all three are listed as completed, with no active trials currently underway.
KTN3379 has been evaluated in three completed Phase 1 trials. NCT02014909 studied safety and pharmacokinetics in adults with advanced tumors and enrolled 64 participants. NCT02473731 was a window of opportunity study in surgically resectable head and neck cancer, and NCT02456701 combined KTN3379 with vemurafenib in BRAF mutant thyroid cancer.
KTN3379 was studied in squamous cell carcinoma of the head and neck in a Phase 1 window of opportunity trial, NCT02473731, conducted in the United States in patients with surgically resectable disease. That study enrolled 12 participants and is completed. KTN3379 remains investigational and is not approved for this indication.