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New treatment option for Vulvar Adenocarcinoma
Official title AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors
ClinicalTrials.gov ID: NCT07454642
What this study is testing
What is AVA6103?
AVA6103 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for vulvar adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The subject is fully informed about the study and is willing and able to sign the informed consent form (ICF).
- Male or female people, ≥18 years of age.
- people with the following tumors reported to be FAP positive, with histological or cytological confirmation of a locally advanced (unresectable)...
- Cervical/vulvar cancer
- SCLC
You likely can't join if
- Has active or suspected central nervous system (CNS) metastases as determined by the Investigator. people may still be eligible if CNS metastases are...
- people who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early...
- 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...
- History of known infection is defined as:
- HIV infection defined as: An AIDS-defining infection within 12 months of planned study Day 1. people on anti-retroviral treatment who are not...
See the full eligibility criteria
Who can join
- The subject is fully informed about the study and is willing and able to sign the informed consent form (ICF).
- Male or female people, ≥18 years of age.
- people 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...
- Cervical/vulvar cancer
- SCLC
- Gastric/GEJ cancer
- PDAC
- HR+ breast cancer
- Has a life expectancy of ≥3 months, in the opinion of the investigator.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 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...
- Has adequate hematological function (applies only to people not receiving therapeutic anticoagulation; people receiving therapeutic anticoagulation should be on a stable dose):
- Absolute neutrophil count of ≥1.5 × 109 cells/L. people with documented benign ethnic neutropenia may be enrolled with an absolute neutrophil count of ≥1.0 × 109 cells/L
- Hemoglobin ≥9.0 g/dL.
- Platelet count of ≥100,000/µL.
- International normalized ratio and activated partial thromboplastin time ≤1.5 times the ULN, except for people on direct acting anticoagulation.
- Has adequate liver function:
- Total bilirubin 1.5 × ULN (except for people with documented Gilbert's Syndrome or liver metastases who must have a total bilirubin \<3 × ULN).
- AST and ALT ≤2.5 × ULN (in people with liver metastases, \<5 × ULN is allowed).
- Has adequate renal function as defined by creatinine clearance ≥ 60 mL/min by the Cockcroft-Gault equation.
- Women of childbearing potential and women who have ≤2 years amenorrhea after start of menopause, must have a negative serum or urine pregnancy test within 7 days prior to Cycle 1 Day 1.
- Contraception requirements:
- Female people of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method (Pearl Index failure rate \< 1% per year) during the...
- Male people with female partners of childbearing potential must agree to using 2 acceptable methods of contraception (Pearl Index failure rate \<1% per year), including a barrier method (with or without spermicide)...
- Male people must agree to refrain from sperm donation during the treatment period and for at least 6 months after the last dose of study drug.
- The subject is willing and able to comply with the protocol, including any PK blood sampling and tumor biopsy requirements and agrees to return to clinic for follow-up visits and examinations.
- For people in Phase 1a or 1b, on treatment tumor biopsy is optional. -
What rules you out
- Has active or suspected central nervous system (CNS) metastases as determined by the Investigator. people may still be eligible if CNS metastases are definitively treated with radiotherapy, the subject is asymptomatic...
- people 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...
- 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...
- History of known infection is defined as:
- HIV infection defined as: An AIDS-defining infection within 12 months of planned study Day 1. people on anti-retroviral treatment who are not established on anti-retroviral treatment for ≥4 weeks and who have a viral...
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as: a positive hepatitis B surface antigen (HBsAG) test at screening. people with a past or resolved HBV infection (defined as having a...
- Chronic HBV (HBsAg positive, undetectable or low HBV DNA and normal ALT).
- people with active disease who are not on/have not initiated anti-retroviral treatment prior to study Day 1.
- people with untreated HCV infection or have not completed treatment for HCV infection.
- people with treated HCV infection but with an HCV viral load above the level of quantification.
- Has a severe infection (requiring IV antibiotic treatment) within 21 days prior to Cycle 1, Day 1 including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
- Has any other clinically significant active disease, metabolic dysfunction, physical examination finding, altered mental status, clinical laboratory finding, or reasonable suspicion of a disease or condition that would...
- Has had major surgery within 21 days prior to Cycle 1, Day 1 (excluding biopsies) or anticipates the need for major surgery during study treatment.
- Is a pregnant or breastfeeding woman.
- Has a known hypersensitivity to any of the components of AVA6103 or any excipient of the product or to other topoisomerase 1 (TOP1) inhibitors.
- Has received prior investigational therapy (defined as a treatment for which there is no Regulatory Authority-approved indication) within 5 half-lives or 28 days (whichever is shorter) of Cycle 1 Day 1.
- Has received any approved anticancer therapy, including chemotherapy or hormonal therapy, within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1, with the following exception:
- Is planned for on-study treatment or has received within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1.
- people who have received a monoclonal antibody.
- Is currently taking St John's Wort, any drugs that are a strong inhibitor or inducer of cytochrome P450 (CYP)3A4, CYP1A2, CYP2D6, or P-glycoprotein (P-gp) such as ketoconazole, Nifedipine, erythromycin and fentanyl.
- Drugs which are strong inhibitors of multidrug resistance protein (MRP)2, MRP3 or MRP4.
- Is planned for on study treatment with any drugs that are sensitive CYP3A4 or organic anion transporting polypeptide (OATP)1B3 substrates, and/or where these drugs will be in the systemic circulation at the start of...
- Has received granulocyte-colony stimulating factor (G-CSF), or red blood cell or platelet transfusion within 14 days prior to Cycle 1 Day 1.
- Has received radiotherapy within 28 days prior to Cycle 1 Day 1, except for limited field palliative radiotherapy, which requires at least a 7-day washout period.
- Has received live attenuated vaccine within 30 days prior to Cycle 1 Day 1. Note: If a COVID-19 vaccine is administered it should be done \>96 hours prior to AVA6103 administration. For the dose escalation phase, it...
- QT interval corrected through use of Fridericia's formula (QTcF) \> 470 ms demonstrated by at least two single ECGs ≥ 30 minutes apart.
The study team makes the final eligibility decision.
Where it's taking place
- Grand Rapids, Michigan, United States
- Irving, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grand Rapids, Michigan, United States; Irving, Texas, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.