Actively Recruiting
AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors
Led by Avacta Life Sciences Ltd · Updated on 2026-03-18
144
Participants Needed
2
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosed with FAP-positive cervical, vulvar, small cell lung, gastric, gastroesophageal junction, or pancreatic ductal adenocarcinoma confirmed by histology or cytology
- Locally advanced (unresectable) or metastatic progressive disease
- Received all standard or FDA-approved treatments, are ineligible, or decline these treatments
- Life expectancy of at least 3 months as determined by investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Recovered from prior radiotherapy, chemotherapy, or surgery toxic effects to Grade 1 or baseline (exceptions for alopecia and peripheral neuropathy up to Grade 2)
- Adequate blood function (specified neutrophil count, hemoglobin, platelet count, and coagulation times)
- Adequate liver function (limits on bilirubin, AST, ALT with exceptions for certain conditions)
- Adequate kidney function (creatinine clearance ≥ 60 mL/min)
- Negative pregnancy test within 7 days prior to first treatment for women of childbearing potential
- Agree to contraception requirements during treatment and for 6 months after last dose
- Willing and able to comply with study procedures and follow-up visits
You will not qualify if you...
- Active or suspected central nervous system metastases unless treated and stable without corticosteroids
- History of active malignancy requiring treatment within 2 years except certain in-situ or non-melanoma skin cancers
- Significant uncontrolled diseases that may affect study compliance
- Clinically unstable or uncontrolled disorders other than primary cancer posing safety risks
- Known HIV infection with recent AIDS-defining infection or uncontrolled viral load
- Active hepatitis B or C infection unless resolved or controlled
- Severe infection requiring IV antibiotics within 21 days before treatment
- Other active diseases or conditions contraindicating investigational drug use
- Major surgery within 21 days prior to treatment or anticipated during study
- Pregnant or breastfeeding women
- Known allergy to AVA6103 or similar drugs
- Prior investigational therapy within 5 half-lives or 28 days before treatment
- Recent anticancer therapy within 14 days before treatment, except planned monoclonal antibody
- Use of drugs strongly affecting CYP enzymes or P-glycoprotein
- Recent use of granulocyte-colony stimulating factors or transfusions
- Recent radiotherapy within 28 days, except limited palliative radiotherapy with washout
- Recent live attenuated vaccine within 30 days before treatment
- QTcF interval greater than 470 ms on ECG assessments
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
NEXT Oncology
Irving, Texas, United States, 75039
Actively Recruiting
2
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
A
Avacta Clinical Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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