A Study of PYX-201 in Advanced Solid Tumors

Exclusion Criteria17

• History of another malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical carcinoma; adequately treated, noninvasive bladder cancer.
• Known symptomatic brain metastases.
• Significant cardiovascular disease within 6 months prior to start of study drug.
• Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug.
• Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
• Failure to recover to baseline severity or Grade ≤1 NCI-CTCAE v5.0 from acute non-hematologic toxicity.
• Participants with NCI-CTCAE v5.0 Grade >1 neuropathy of any etiology.
• Prior solid organ or bone marrow progenitor cell transplantation.
• Prior high-dose chemotherapy requiring stem cell rescue.
• Received systemic anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to the start of study drug.
• Palliative radiation therapy within 14 days prior to the start of study drug.
• Previously received extra domain B splice variant of fibronectin (EDB+FN) targeting treatments at any time prior to the start of PYX-201 treatment.
• History of uncontrolled diabetes mellitus.
• History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Participants with corneal epithelial disease, with the exception of mild punctate keratopathy
• Participants with the best-corrected visual acuity in the worst-seeing eye worse than 20/100 (Snellen equivalent).
• Participants with a history of (noninfectious) pneumonitis/ interstitial lung disease that required steroids, has current pneumonitis/ interstitial lung disease, or evidence of active pneumonitis on screening chest CT scan or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.