A FIRST-IN-HUMAN, PHASE 1, DOSE-ESCALATION STUDY OF SGR-3515 IN PARTICIPANTS WITH ADVANCED SOLID TUMORS

Eligibility: Inclusion Criteria
  •   * Diagnosis of advanced/metastatic solid tumor
  •   * Measurable disease per RECIST version 1.1
  •   * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  •   * Participant must understand and sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures
  •   * Adequate bone marrow and organ function
  •   * Women of child-bearing potential (WOCBP) or males must agree to use highly effective contraception for the duration of study and for 90 days after the last dose of study drug
Exclusion Criteria
  •   * Participants with primary Central Nervous System (CNS tumors).
  •   * Participant has received prior systemic anti-cancer treatments or other investigational agents = 21 days of first dose of study drug, or 5 half-lives, whichever is shorter
  •   * Participant who has received definitive local control radiation (any dose greater than 50 Gy) 42 days prior to the first dose of study drug.
  •   * Participant who has received major surgeries = 21 days prior to first dose of study drug
  •   * Participants who have not recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade 2 alopecia, peripheral neuropathy and ototoxicity.
  •   * Participant who has another clinically significant invasive malignancy, as determined by the investigator, = 2 years prior to the first dose