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.
The subject is fully informed about the study and is willing and able to sign the informed consent form (ICF).
Male or female subjects, ≥18 years of age.
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
Cervical/vulvar cancer
Has active or suspected central nervous system (CNS) metastases as determined by the Investigator. Subjects may still be eligible if CNS metastases are definitively treated with radiotherapy, the subject is asymptomatic, not requiring corticosteroids (prednisone or equivalent must be 10 mg/day or less), and have had repeat imaging no less than 4 weeks after completing radiotherapy to document stability.
Subjects who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal prostate-specific antigen) within 2 years of study entry.
Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.
History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic or psychiatric) other than their primary malignancy, that in the opinion of the Investigator would pose a risk to subject safety or interfere with study evaluations, procedures, or completion.
Single group
AVA6103
DrugAVA6103 is a FAP-activated Exatecan
Adverse events (AEs)
Incidence and severity of treatment-emergent (TE) and treatment-related adverse events (TRAEs) and Serious Adverse Events (SAEs).
Dose-limiting toxicities (DLTs)
Incidence and nature of DLTs
Objective response rate (ORR)
ORR is defined as the proportion of patients achieving a best overall response of confirmed partial responses (PR) or complete response (CR), per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Duration of Response (DoR)
DoR is defined as the duration of time from date of first response to date of disease progression, as per RECIST v1.1
Progression-free-survival (PFS)
PFS is defined as the time from the date of the first dose to the date of the first documentation of confirmed disease progression or death, whichever occurs first, as per RECIST v1.1
Overall survival (OS)
Overall survival (OS), defined as the date of first dose) to the occurrence of death from any cause
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