A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours

Recruiting now · Phase 1

Conditions studied: Salivary Gland Tumor, Urothelial Carcinoma, Ovarian Carcinoma, Breast Cancer, Soft Tissue Sarcoma

In brief

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.

Key facts

Study ID

NCT04969835

Run by

Avacta Life Sciences Ltd

People needed

158

Starts

2021-07-16

Expected to finish

2026-08-15

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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) and/or metastatic:
• a. salivary gland, urothelial, ovarian, or breast carcinoma, who have either relapsed or progressed on SoC treatment or are intolerant or nonamenable to SoC treatment; OR b. soft-tissue sarcoma who: i. is treatment naïve in the locally advanced (unresectable) or metastatic setting and anthracycline naïve (any setting) and would otherwise be a candidate for doxorubicin hydrochloride treatment; OR ii. has received a total doxorubicin dose of < 150mg/m2 (any setting (< 2 cycles of 75 mg/m2 Q21 days) and has discontinued due to intolerance or toxicity related to doxorubicin
• b) Phase 1b: patients with histological or cytological confirmation of a locally advanced (unresectable) and/or metastatic tumour of one of the following types:
• 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 metastatic setting
• 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. In addition, patients with adenoid cystic carcinoma subtypes must not have received prior cytotoxic therapy for locally advanced or metastatic disease. Adenoid cystic carcinoma subtype may be capped at 15 patients (assuming cohort of approximately 30 patients)
• 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 screening. However, this requirement does not apply if the patient is newly diagnosed, recurrent or newly metastatic.
• 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 infusion. Prior anthracycline use must have been in the adjuvant or neoadjuvant setting only.
• 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 medically feasible.
• 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 can be up to CTCAE grade 2).
• 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).

You may not qualify 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 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), left ventricular ejection fraction (LVEF) <55% or the low limit of institutional normal limit (whichever is lower) by echocardiogram (ECHO), serious cardiac arrhythmia requiring treatment (exceptions include atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months prior to Cycle 1 Day 1, or history of uncontrolled cardiovascular disease or high-sensitivity troponin above normal at baseline (T or I).
• 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 rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval >250 msec). Has any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, known family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval, a baseline resting bradycardia <45 beats/min or a baseline resting tachycardia of >100 beats/min.
• 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] antibody test) are eligible.
• 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 of an investigational drug in the opinion of the investigator.

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• The Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde — Glasgow, United Kingdom (enrolling)
• St James's University Hospital, The Leeds Teaching Hospitals NHS Trust — Leeds, United Kingdom (enrolling)
• The Royal Marsden, NHS Foundation Trust — London, United Kingdom (enrolling)
• The Christie NHS Foundation Trust — Manchester, United Kingdom (enrolling)
• The Freeman Hospital, Newcastle-upon-Tyne NHS Foundation Trust — Newcastle upon Tyne, United Kingdom (enrolling)
• Weston Park Cancer Centre, Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, United Kingdom

Full record on ClinicalTrials.gov

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