Phase 1a/2a Dose Escalation Trial to Determine Safety, Tolerance, MTD, and Preliminary Antineoplastic Activity of AVID100, in Patients With Advanced or Metastatic Solid Tumors of Epithelial Origin

Phase 1 Dose Escalation: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) in Cycle 1

时间窗: Cycle 1 during Dose Escalation (ie the first 3 weeks of dosing)

Any of the following toxicities, if judged to be associated with study, were considered a DLT: 1. Evidence of pulmonary fibrosis 2. G3 non-hematologic toxicity regardless of duration with the exceptions of: * G3 nausea, vomiting, diarrhea, or fatigue lasting \< 2 days * G3 asymptomatic electrolyte abnormalities lasting \< 3 days not considered clinically relevant 3. AST and/or ALT elevation \> 3 x ULN with total bilirubin \> 2 x ULN without initial findings of cholestasis, that cannot be explained by other factors 4. Any G4 non-hematologic toxicity with the exception of: • G4 asymptomatic electrolyte abnormalities lasting \< 7 days not considered clinically significant 5. Neutropenia that is: * \> G3 and associated with fever * G4 and sustained (ANC \< 500 per mm3, duration \> 5 days) 6. Thrombocytopenia that is: * G3 with clinically significant hemorrhage or requirement for transfusion * G4 (platelets \< 25,000 per mm3) 7. Inability to complete Cycle 1 at the assigned dose

Phase 2a: Number of Participants With Best Overall Response by RECIST 1.1

时间窗: Imaging for Disease status (tumour measurements) occurred after every even cycle for the full duration of treatment and at EOT visit up to approximately 24 weeks total

Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening and every 2 cycles during study treatment. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non- target) must have reduction in short axis to \< 10 mm.