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 | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
PYX-201 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical trials, including a study of PYX-201 as a monotherapy and a study of PYX-201 in combination with pembrolizumab, both in patients with advanced solid tumors.
PYX-201 targets extradomain-B of fibronectin (EDB+FN), a non-cellular structural component found in the tumor microenvironment. By targeting this component, PYX-201 is designed to deliver its therapeutic effect specifically to solid tumors.
PYX-201 is being developed by Pyxis Oncology, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol PYXS. The company is conducting clinical trials to evaluate the safety and efficacy of PYX-201 in patients with advanced solid tumors.
PYX-201 is in Phase 1 of clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 trials are recruiting patients to assess the drug's safety, tolerability, and preliminary efficacy in advanced solid tumors.
PYX-201 is being studied in two Phase 1 clinical trials. The first, NCT05720117, is a study of PYX-201 alone in advanced solid tumors with an enrollment of 330 participants. The second, NCT06795412, is a Phase 1/2 study of PYX-201 in combination with pembrolizumab in advanced solid tumors, enrolling 220 participants.
No, PYX-201 is not the same as pembrolizumab. PYX-201 is an investigational small molecule that targets extradomain-B of fibronectin, while pembrolizumab is an approved immunotherapy that targets PD-1. They are being studied together in a combination trial for advanced solid tumors.