Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PYX-201 · 2 trials · 3 indications
DLT is defined as (1) an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs after the treatment with PYX-201 and (2) meets any of the predefined criteria outlined in the protocol.
Adverse Events as characterized by type, incidence, seriousness, relationship to study treatment, timing, and severity (as graded by NCI-CTCAE Version 5.0). Any clinically significant changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) parameters will be recorded as AEs.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation | EXPERIMENTAL | Participants will receive escalating doses of PYX-201 to evaluate the safety, tolerability, and preliminary efficacy of PYX-201 in combination with pembrolizumab. |
| Part 2: Dose Expansion | EXPERIMENTAL | Part 2 dose-expansion cohorts will be opened based on emerging data to further inform the safety, tolerability, and preliminary efficacy determinations as defined. |
| Dose Escalation | EXPERIMENTAL | - |
| Dose Expansion Cohort A (HNSCC) | EXPERIMENTAL | - |
| Dose Expansion Cohort B (TNBC) | EXPERIMENTAL | - |
| Dose Expansion Cohort C (HR+ HER2- BC) | EXPERIMENTAL | - |
| Dose Expansion Cohort D (Other Solid Tumor Types) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PYX-201 | DRUG | Intravenous (IV) infusion. |
| pembrolizumab | DRUG | IV infusion. |
Inclusion Criteria 1. Histologically or cytologically confirmed advanced solid tumors, including first-line (1L) head and neck squamous cell carcinoma (HNSCC), advanced or metastatic triple negative breast cancer (TNBC), hormone receptor positive (HR+) and human epidermal growth factor receptor 2 n...
| 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 |
PYX-201 is an investigational therapy being studied for the treatment of advanced solid tumors. It is a small molecule developed by Pyxis Oncology, Inc. and is currently in Phase 1 clinical development. It is not yet approved for any indication.
PYX-201 targets extradomain-B of fibronectin, also known as EDB+FN. This target is a non-cellular structural component of the tumor microenvironment. By binding EDB+FN, PYX-201 is designed to act on a component of the tumor stroma rather than on tumor cells directly.
PYX-201 is being developed by Pyxis Oncology, Inc., which trades on the Nasdaq under the ticker PYXS. The company is the sponsor of the clinical trials evaluating PYX-201 in advanced solid tumors.
PYX-201 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA or any other regulatory agency. Two Phase 1 studies are currently recruiting participants.
PYX-201 is being evaluated in two recruiting Phase 1 trials. NCT05720117 is a study of PYX-201 in advanced solid tumors with an enrollment of 330. NCT06795412 is a Phase 1/2 study of PYX-201 in combination with pembrolizumab in advanced solid tumors with an enrollment of 220.
Yes. PYX-201 trials are biomarker selected, meaning enrollment is guided by biomarker criteria. The studies enroll adults aged 18 years and older of all sexes and do not include healthy volunteers. NCT05720117 runs in the United States, Belgium, Spain, and the United Kingdom, while NCT06795412 runs in the United States, France, and Spain.