PTT-936 Alone or in Combination in Patients With Locally Advanced or Metastatic Solid Tumors

Patients with leptomeningeal (LMD) metastases or patients with new and/or progressive brain metastases at the time of study entry. Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after central nervous system (CNS)-directed treatment (radiotherapy and/or surgery), as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.

History of primary malignancy other than the diseases under study, not in remission greater than three (3) years prior to Day 1. Exceptions that do not require a 3-year remission include: adequately treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy or squamous intraepithelial lesion on Papanicolaou (PAP) smear, in situ prostate cancer (with no evidence of active disease for two [2] years prior to Day 1), or resected melanoma in situ and radically resected papillary thyroid carcinoma.

Persistence of Adverse Events (AEs) from prior anti-cancer therapy that have not resolved to Grade 1 (except for alopecia and hypothyroidism), or any history of Grade ≥ 3 immune-related adverse events (irAEs), Grade ≥ 2 pneumonitis, hypophysitis or encephalitis related to immunotherapy, or other Grade ≥ 3 drug-related CNS toxicity.

Active systemic autoimmune disease or a history of autoimmune disorder that may relapse (e.g., systemic lupus erythematosus [SLE], rheumatoid arthritis, inflammatory bowel disease [IBD], autoimmune thyroid disorder*, multiple sclerosis, vasculitis, glomerulitis, eczema, psoriasis, etc.).