AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors

This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.

Inclusion Criteria: 1. The subject is fully informed about the study and is willing and able to sign the informed consent form (ICF). 2. Male or female subjects, ≥18 years of age. 3. Subjects with the following tumors reported to be FAP positive, with histological or cytological confirmation of a locally advanced (unresectable) and/or metastatic progressing disease that have received all standard-of-care or Food and Drug Administration (FDA) approved treatments, or are ineligible for those treatments, or decline those treatments 1. Cervical/vulvar cancer 2. SCLC 3. Gastric/GEJ cancer 4. PDAC 5. CRC 6. HR+ breast cancer 4. Has a life expectancy of ≥3 months, in the opinion of the investigator. 5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Has recovered from all acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure (must have resolved to CTCAE Grade ≤1 or returned to baseline, whichever is greater. Exceptions include alopecia and peripheral neuropathy, which can be up to CTCAE Grade 2). 7. Has adequate hematological function (applies only to subjects not receiving therapeutic anticoagulation; subjects receiving therapeutic anticoagulation should be on a stable dose): 1. Absolute neutrophil count of ≥1.5 × 109 cells/L. Subjects with documented benign ethnic neutropenia may be enrolled with an absolute neutrophil count of ≥1.0 × 109 cells/L 2. Hemoglobin ≥9.0 g/dL. 3. Platelet count of ≥100,000/µL. 4. International normalized ratio and activated partial thromboplastin time ≤1.5 times the ULN, except for subjects on direct acting anticoagulation. 8. Has adequate liver function: 1. Total bilirubin 1.5 × ULN (except for subjects with documented Gilbert's Syndrome or liver metastases who must have a total bilirubin \ 470 ms demonstrated by at least two single ECGs ≥ 30 minutes apart.