A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors

Exclusion Criteria

• •Colorectal cancer patients with an unresected primary colorectal tumor and non-small-cell lung cancer with predominant squamous histology (ie, squamous cell carcinoma of the lung) are excluded unless otherwise discussed and approved by Sponsor
• •Clinically unstable central nervous system (CNS) tumors or brain metastasis (stable and/or asymptomatic CNS metastases allowed)
• •Have not recovered to ≤ Grade 1 or baseline from all AEs due to previous therapies (patients with ≤ Grade 2 neuropathy, endocrine-related irAEs, or other AEs may be eligible after discussion with the Sponsor)
• •Has an active vasculitis that has required systemic treatment in the past 2 years prior to starting study treatment
• •Significant (ie, ≥ Grade 2) ocular disturbances
• •Variceal bleeding within 6 months prior to treatment, currently untreated or incompletely treated varices with bleeding, or who otherwise are at a high risk of bleeding
• •Any other concurrent antineoplastic treatment except for allowed local radiation of lesions for palliation (to be considered non-target lesions after treatment) and hormone ablation
• •Uncontrolled or life-threatening symptomatic concomitant disease, including known symptomatic HIV positive with an AIDS defining opportunistic infection within the last year, known symptomatic active hepatitis B or C, or known active tuberculosis
• •Has undergone a major surgery within 3 weeks prior to starting study treatment or has inadequate healing or recovery from complications of surgery prior to starting study treatment
• •Has received prior radiotherapy within 2 weeks prior to starting study treatment
• •Has or had a potentially life-threatening second malignancy requiring systemic treatment within the last 3 years, or which would impede evaluation of treatment response
• •Clinically significant cardiovascular disease
• •Patients on a potent CYP3A inhibitor or CPY3A inducer who cannot be changed to another medication
• •Has an active infection requiring concurrent systemic antibiotic therapy
• •A woman of child-bearing potential (WOCBP) who has a positive pregnancy test prior to treatment
• •Is breastfeeding or expecting to conceive or father children within the projected duration of the study