BridgeMD
Tests treatment safety and results for Salivary Gland Tumor
Official title A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours
ClinicalTrials.gov ID: NCT04969835
What this study is testing
What is AVA6000?
AVA6000 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for salivary gland tumor.
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, multicentre dose escalation study investigating AVA6000 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumours 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 patient has been fully informed about the study and has signed the Informed Consent Form.
- Male or female patients, ≥ 18 years of age.
- a) Phase 1a: patients with tumours reported to be FAP positive with histological or cytological confirmation of a locally advanced (unresectable)...
- High grade soft tissue sarcoma: histologically proven locally advanced or metastatic, unresectable progressive or recurrent DDLS or UPS who have...
- SGC: Locally advanced or metastatic salivary gland confirmed by histopathology that cannot be completely resected by surgery who have received 0 or 2...
You likely can't join if
- Has received trastuzumab within 7 months of the planned Cycle 1 Day 1 AVA6000 infusion.
- Has received a prior total cumulative anthracycline dose of ≥ 350 mg/m2 doxorubicin (or equivalent anthracycline dose).
- Has clinically significant or untreated central nervous system (CNS) metastases or leptomeningeal disease requiring treatment, as determined by the...
- Patients who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and...
- Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.
- In the opinion of the investigator, has uncontrolled hypertension (systolic blood pressure \>150 mm Hg and/or diastolic blood pressure \>100 mm Hg)...
See the full eligibility criteria
Who can join
- The patient has been fully informed about the study and has signed the Informed Consent Form.
- Male or female patients, ≥ 18 years of age.
- a) Phase 1a: patients with tumours reported to be FAP positive with histological or cytological confirmation of a locally advanced (unresectable) and/or metastatic: a. salivary gland, urothelial, ovarian, or breast...
- High grade soft tissue sarcoma: histologically proven locally advanced or metastatic, unresectable progressive or recurrent DDLS or UPS who have received 0 or 1 prior lines of therapy in the locally advanced or...
- SGC: Locally advanced or metastatic salivary gland confirmed by histopathology that cannot be completely resected by surgery who have received 0 or 2 prior lines of therapy in the locally advanced or metastatic setting...
- TNBC: Locally advanced or metastatic triple negative breast cancer confirmed by histopathology who have received any prior therapy in the locally advanced or metastatic setting. Patients must be BRCA wild-type.
- In Phase 1b, patients must meet the following additional criteria: Patients must demonstrate (as documented, per the investigator's assessment), radiological disease progression over the 6 months (±2 months) prior to...
- Patients must have measurable disease per RECIST.
- Patients with high grade soft tissue sarcoma or salivary gland cancer must not have previously received an anthracycline-based therapy.
- Patients with TNBC may receive up to 250mg/m2 of prior doxorubicin (or an equivalent anthracycline). Prior anthracycline based therapy must have been completed at least 6 months before the planned Cycle 1 Day 1 AVA6000...
- Patients must provide at least 1 tissue sample collection, either archival or fresh tissue (approximately 10 slides) unless the biopsy is medically not able to be performed or the principal investigator deems it is not...
- Has a life expectancy of ≥12 weeks, in the opinion of the investigator.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 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, except alopecia and peripheral neuropathy, which...
- Has adequate haematological function (applies only to patients not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose):
- Absolute Neutrophil count (ANC) of ≥1.5 × 109 cells/L.
- Haemoglobin ≥9.0 g/dL.
- Platelet count of ≥75,000/µL.
- International normalised ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 times the upper limit of normal (ULN).
- Has adequate liver function:
- Total bilirubin below ULN (except for patients with Gilbert's Syndrome who must have a total bilirubin \<3 × ULN).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (in patients with liver metastases, \<5 × ULN is allowed).
- Alkaline phosphatase (ALP) \<5 × ULN in patients with documented liver or bone metastases, or ALP \< 2 × ULN in patients without documented metastases.
- Has adequate renal function (creatinine clearance ≥50 mL/min by Cockcroft-Gault formula) or patients with normal plasmatic creatinine despite creatinine clearance \< 50 mL/min as per Cockcroft-Gault formula are eligible...
- Women of childbearing potential (WOCBP) and women who have ≤ 2 years amenorrhea after start of menopause: has a negative serum pregnancy test within 7 days prior to Cycle 1 Day 1.
- Contraception requirements:
- Female patients 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 patients 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 patients must agree to refrain from sperm donation during the treatment period and for at least 6 months after the last dose of study drug.
- All patients should have peripheral veins or central line that are, in the opinion of the Investigator or delegate, suitable for peripheral or central intravenous infusion of AVA6000.
- The patient is willing and able to comply with the protocol, including any PK blood sampling requirements and agrees to return to hospital for follow-up visits and examinations.
What rules you out
- Has received trastuzumab within 7 months of the planned Cycle 1 Day 1 AVA6000 infusion.
- Has received a prior total cumulative anthracycline dose of ≥ 350 mg/m2 doxorubicin (or equivalent anthracycline dose).
- Has clinically significant or untreated central nervous system (CNS) metastases or leptomeningeal disease requiring treatment, as determined by the Investigator.
- Patients 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 PSA) within 2 years of study entry.
- Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.
- In the opinion of the investigator, has uncontrolled hypertension (systolic blood pressure \>150 mm Hg and/or diastolic blood pressure \>100 mm Hg), unstable angina, CHF (New York Heart Association (NYHA) Class \>II)...
- Has a screening baseline mean corrected QTcF interval by Fridericia (QTcF) of \>480 msec. Electrocardiograms (ECGs) will be evaluated locally at the investigator site. Has any clinically significant abnormalities in...
- HIV infection:
- Patients with an AIDS-defining infection within 12 months of planned study Day 1.
- Patients 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 (HBV) or hepatitis C (HCV) infection defined as:
- Has a positive hepatitis B surface antigen (HBsAG) test at screening. Patients with a past or resolved HBV infection (defined as having a negative HBsAG test and a positive antibody to hepatitis B core antigen [antiHBc]...
- Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
- Chronic HBV (HbSAg positive, undetectable or low HBV DNA and normal ALT).
- Patients with active disease who have not on/initiated anti-retroviral treatment prior to study Day 1.
- Patients with untreated HCV infection or have not completed treatment for HCV infection.
- Patients with treated HCV infection but with a HCV viral load above the level of quantification.
- Has a severe infection (requiring iv treatment) within 21 days prior to Cycle 1, Day 1 including, but not limited to, hospitalisation for complications of infection, bacteraemia, or severe pneumonia.
- Has any other clinically significant active disease, metabolic dysfunction, physical examination finding, clinical laboratory finding, or reasonable suspicion of a disease or condition that would contraindicate the use...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Glasgow, United Kingdom
- Leeds, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Newcastle upon Tyne, United Kingdom
- Sheffield, United Kingdom
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 New York, New York, United States; Houston, Texas, United States; Seattle, Washington, United States; Glasgow, United Kingdom; Leeds, United Kingdom; London, United Kingdom and 3 more location(s). 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.