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WTX-330 · 2 trials · 2 indications
RECIST = Response Evaluation Criteria in Solid Tumors
| Arm | Type | Description |
|---|---|---|
| Dose- and Regimen Finding | EXPERIMENTAL | Regimen 1 Fixed Dose for 28 days then Regimen 2 Step-up Dose for 28 days |
| Dose Expansion Arm A | EXPERIMENTAL | n\~20 Patients with locally advanced or metastatic cutaneous malignant melanoma who have been treated with a standard of care (SOC) checkpoint inhibitor (CPI) regimen and who demonstrate primary or secondary resistance to this therapy |
| Dose Expansion Arm B | EXPERIMENTAL | n\~20 Patients with locally advanced or metastatic microsatellite-stable (MSS) colorectal carcinoma (CRC) who have progressed on or are intolerant of SOC therapies and who are naïve to immunotherapy |
| Dose Expansion Arm C | EXPERIMENTAL | n\~20 Patients with advanced NHL who are relapsed/refractory to SOC therapies and who are CPI naïve |
| WTX-330 dose escalation | EXPERIMENTAL | Patients with relapsed/refractory advanced or metastatic solid tumors |
| WTX-330 dose expansion in patients for whom CPI therapy is indicated (Arm A) | EXPERIMENTAL | WTX-330 dose expansion in patients with tumor types for which a CPI is indicated/approved who demonstrate primary or secondary resistance to an anti-PD(L)1-based regimen |
| WTX-330 dose expansion in patients for whom CPI therapy is not indicated (Arm B) | EXPERIMENTAL | WTX-330 dose expansion in patients with tumor types for which a CPI is not indicated/ approved |
| Name | Type | Description |
|---|---|---|
| WTX-330 | DRUG | Investigational Product |
Inclusion Criteria: 1. Age ≥ 18 years, 2. Dose escalation (Part 1): Patients with relapsed/refractory locally advanced or metastatic solid tumor for which the patient has progressed on or is intolerant of standard therapy, or for whom no standard therapy with proven benefit exists. Patients with ca...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
WTX-330 is an investigational biologic developed by Werewolf Therapeutics for advanced or metastatic solid tumors and non-Hodgkin lymphoma. It has been studied in Phase 1 and Phase 1/2 clinical trials in adult patients in the United States. It is not described as an approved therapy.
WTX-330 is being developed for the treatment of advanced or metastatic solid tumors and non-Hodgkin lymphoma in adults. Its clinical trials enrolled patients aged 18 years and older with these selected advanced or metastatic cancers.
WTX-330 is developed by Werewolf Therapeutics, Inc., which trades under the ticker HOWL. The company sponsored the Phase 1 and Phase 1/2 studies of WTX-330 conducted at sites in the United States.
WTX-330 has been evaluated in Phase 1 and Phase 1/2 clinical development. Both of its listed trials, NCT05678998 and NCT06939283, are completed, and the program enrolled a combined total of 49 patients across the two studies.
WTX-330 has been studied in two completed trials: NCT05678998, a Phase 1 study in advanced or metastatic solid tumors or non-Hodgkin lymphoma with 25 patients, and NCT06939283, a Phase 1b/2 dose-finding and expansion study in the same conditions with 24 patients.
The two WTX-330 trials enrolled 49 patients in total. NCT05678998 enrolled 25 patients and NCT06939283 enrolled 24 patients. Both studies were conducted in the United States and included adults aged 18 years and older.