Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
WTX-124 · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| WTX-124 monotherapy dose escalation | EXPERIMENTAL | WTX-124 monotherapy dose escalation |
| WTX-124 in combination with pembro dose escalation | EXPERIMENTAL | WTX-124 in combination with pembrolizumab (pembro) dose escalation |
| Arm A: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic RCC. | EXPERIMENTAL | Arm A: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic RCC. |
| Arm B: WTX-124 monotherapy dose expansion. Advanced or metastatic cutaneous malignant melanoma. | EXPERIMENTAL | Arm B: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cutaneous malignant melanoma. |
| Arm C: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cSCC. | EXPERIMENTAL | Arm C: WTX-124 monotherapy dose expansion. Patients with advanced or metastatic cSCC. |
| Arm D: WTX-124 in combination with pembro dose expansion. Advanced or metastatic RCC. | EXPERIMENTAL | Arm D: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic RCC. |
| Arm E: WTX-124 with pembro dose expansion. Advanced or metastatic cutaneous melanoma. | EXPERIMENTAL | Arm E: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic cutaneous melanoma. |
| Arm F: WTX-124 in combination with pembro dose expansion. Advanced/metastatic PD-L1-positive NSCL | EXPERIMENTAL | Arm F: WTX-124 in combination with pembrolizumab dose expansion. Patients with advanced or metastatic PD-L1-positive NSCLC lines. |
| Name | Type | Description |
|---|---|---|
| WTX-124 | DRUG | Investigation Product Monotherapy |
| pembrolizumab | DRUG | Investigation Product in combination with approved therapy |
Inclusion Criteria: Each patient must meet all the following criteria to participate in the study: 1. Has histological or cytological documentation of a solid tumor indication for which a CPI (e.g. anti-PD-(L)1 is indicated for all parts of the clinical study; 2. Monotherapy Dose Escalation: P...
| 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-124 is an investigational therapy being studied in adults with selected advanced or metastatic solid tumors. It is a biomarker-selected oncology candidate, meaning trial enrollment is guided by specific tumor biomarkers. It is not approved for any indication and remains in clinical development.
WTX-124 is being developed by Werewolf Therapeutics, Inc., which trades under the ticker HOWL. The company is the sponsor of the clinical program evaluating the candidate in advanced or metastatic solid tumors.
WTX-124 is in Phase 1 clinical development. Its single registered study, NCT05479812, was a Phase 1 dose escalation and expansion trial that has been completed. The drug is investigational and has not received FDA approval.
WTX-124 has been evaluated in one registered clinical trial, NCT05479812, titled a dose escalation and expansion study of WTX-124 as monotherapy and in combination with pembrolizumab in patients with selected advanced or metastatic solid tumors. The Phase 1 study enrolled 156 participants across sites in the United States and is completed.
No. WTX-124 is an investigational drug in Phase 1 clinical development and has not been approved by the FDA for any indication. Its only registered trial, NCT05479812, has been completed, and no approval has been granted.
NCT05479812 was a Phase 1 dose escalation and expansion study of WTX-124 given as monotherapy and in combination with pembrolizumab in patients with selected advanced or metastatic solid tumors. It was a controlled, non-randomized, open-label trial that enrolled 156 adults aged 18 and older in the United States.