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 |