Actively Recruiting
A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6103, a Novel FAP-activated Exatecan, Administered Intravenously in Subjects With Locally Advanced or Metastatic Selected Solid Tumors
Led by Avacta Life Sciences Ltd · Updated on 2026-06-02
174
Participants Needed
3
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating AVA6103, a novel FAP-activated Exatecan drug, in patients with locally advanced or metastatic solid tumors that are likely positive for fibroblast activation protein (FAP). This first-in-human, Phase 1, open-label, multicenter study aims to assess the safety, tolerability, and dosing of AVA6103 in patients who have cancers such as cervical, vulvar, small cell lung, gastric, pancreatic, colorectal, and hormone receptor positive breast carcinoma. The study includes a dose escalation phase followed by a dose expansion phase to evaluate initial therapeutic activity and pharmacokinetics. The study has two parts: Phase 1a dose escalation and Phase 1b dose expansion. In Phase 1a, patients receive escalating doses of AVA6103 intravenously either every 3 weeks (Q3W) or every 2 weeks (Q2W) to find the maximum tolerated dose or recommended phase 2 dose. In Phase 1b, patients receive AVA6103 at the recommended dose until disease progression, unacceptable side effects, withdrawal, or death. Treatment continues under close monitoring in both phases. Participants will undergo regular assessments including monitoring of adverse events, dose-limiting toxicities, and pharmacokinetic blood sampling. Researchers will track tumor response, duration of response, progression-free survival, overall survival, and drug concentration in the blood. Safety is followed up to 30 days after the last dose, with overall survival monitored up to one year. Participants are expected to comply with study procedures, including optional tumor biopsies and scheduled clinic visits for evaluations throughout the study period.
CONDITIONS
Brief 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 subjects aged 18 years or older
- Histological or cytological confirmation of locally advanced (unresectable) or metastatic progressing disease reported to be FAP positive
- Tumor types: cervical/vulvar cancer, small cell lung cancer, gastric/GEJ cancer, pancreatic ductal adenocarcinoma, colorectal cancer, hormone receptor positive breast cancer
- Have received all standard or FDA-approved treatments, or are ineligible for or decline such treatments
- Life expectancy of at least 3 months as judged by the investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Recovered from acute toxic effects of prior therapies to Grade 1 or baseline, except alopecia and peripheral neuropathy up to Grade 2
- Adequate hematological function including neutrophil count, hemoglobin, platelet count, and coagulation parameters
- Adequate liver function with specified bilirubin, AST, and ALT levels
- Adequate renal function with creatinine clearance ≥ 60 mL/min
- Negative pregnancy test for women of childbearing potential within 7 days prior to treatment
- Contraception use during treatment and for at least 6 months after last dose for men and women of childbearing potential
- Willing and able to comply with study protocol including blood sampling and follow-up visits
You will not qualify if you...
- Active or suspected central nervous system metastases unless treated, asymptomatic, and stable
- History of active other malignancies within 2 years except certain in-situ or non-melanoma cancers
- Significant uncontrolled concomitant disease affecting compliance
- Clinically unstable or uncontrolled disorders beyond primary cancer
- Active infections including untreated or uncontrolled HIV, hepatitis B or C
- Severe infections requiring intravenous antibiotics within 21 days before treatment
- Other clinically significant active diseases or conditions contra-indicating investigational drug use
- Major surgery within 21 days prior to treatment
- Pregnant or breastfeeding women
- Known hypersensitivity to AVA6103 components or related drugs
- Prior investigational therapy within 5 half-lives or 28 days before treatment
- Recent anticancer therapy within 14 days prior to treatment with exceptions
- Use of certain drugs that interact with AVA6103 metabolism
- Recent granulocyte-colony stimulating factor or transfusions within 14 days
- Recent radiotherapy within 28 days except limited palliative radiotherapy
- Use of live attenuated vaccines within 30 days prior to treatment
- QTcF interval > 470 ms confirmed by ECGs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies by participant, continuing until progression or discontinuation
Participants receive intravenous AVA6103 either every 3 weeks or every 2 weeks. Treatment continues until disease progression, unacceptable toxicities, withdrawal from treatment, or death.
Repeated visits every 2 or 3 weeks for dosing and assessments
Duration - Up to one year after last dose
Participants are monitored for safety and survival up to one year after their last dose of AVA6103.
Periodic visits for safety and survival assessments
Trial Site Locations
Total: 3 locations
1
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
2
NEXT Oncology
Irving, Texas, United States, 75039
Actively Recruiting
3
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
A
Avacta Clinical Team
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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