AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors (NCT07454642) | Clinical Trial Compass
RecruitingPhase 1
AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors
United States144 participantsStarted 2026-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. SCLC
✓. Gastric/GEJ cancer
✓. PDAC
✓. Has a life expectancy of ≥3 months, in the opinion of the investigator.
Exclusion criteria
✕. 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.
What they're measuring
1
Adverse events (AEs)
Timeframe: From Day 1 until up to 30 days after last dose of study drug.
2
Dose-limiting toxicities (DLTs)
Timeframe: 21 days from the first dose for the every 3 week dosing schedule and 28 days from the first dose for the every 2 week schedule
. 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.
✕. History of known infection is defined as:
✕. HIV infection defined as: An AIDS-defining infection within 12 months of planned study Day 1. Subjects on anti-retroviral treatment who are not established on anti-retroviral treatment for ≥4 weeks and who have a viral load \>400 copies/mL prior to study Day 1.
✕. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as: a positive hepatitis B surface antigen (HBsAG) test at screening. Subjects with a past or resolved HBV infection (defined as having a negative HBsAG test and a positive antibody to hepatitis B core antigen antibody test) are eligible. Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
✕. Chronic HBV (HBsAg positive, undetectable or low HBV DNA and normal ALT).