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AVA6000 for Advanced Solid Tumors

This study is testing a new drug called AVA6000 in people with advanced solid tumors, including salivary gland, urothelial (bladder), ovarian, breast, and soft tissue sarcoma cancers. AVA6000 is a special form of doxorubicin, a chemotherapy drug. The main goals are to see how safe AVA6000 is, what side effects it causes, and how the body handles the drug. Researchers will also look for early signs that the drug is working. You may be able to join if you are 18 or older and have a locally advanced or metastatic (spread to other parts of the body) solid tumor that is likely to be FAP positive (a protein found on some cancer cells). The study is currently recruiting participants.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know which treatment you are receiving. It will involve about 158 participants and is designed to find the right dose of AVA6000.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for side effects from the first dose until up to 30 days after your last dose of AVA6000.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04969835

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Avacta Life Sciences Ltd
~158 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:AVA6000

At a glance

Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicities (DLTs)
Measured over Up to 28 days after the first dose of study therapy
+4 more outcomes measured

Conditions

Salivary Gland Tumor
Urothelial Carcinoma
Ovarian Carcinoma
Breast Cancer
Soft Tissue Sarcoma

Explore related trials

Breast CarcinomaOvarian CarcinomaSalivary Gland NeoplasmSoft Tissue SarcomaSolid NeoplasmUrothelial CarcinomaProlyl Endopeptidase FAP

Where it's being run

9 sites across 4 states
United Kingdom6
New York1
Texas1
Washington1

Study leadership

  • Chris Twelves, MD · PRINCIPAL_INVESTIGATOR · St James's University Hospital, Leeds, UK

Who to contact

Avacta Life Sciences
[email protected]
+44 (0)20 3911 0353
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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. 5. Has a life expectancy of ≥12 weeks, in the opinion of the investigator. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 7. 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). 8. 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). 9. 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. 10. 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 for the study. 11. 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. 12. 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 treatment period and for at least 6 months after the last dose of study drug.
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) during the treatment period and for at least 6 months after the last dose of study drug.
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. 13. 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. 14. 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.

Exclusion

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. 9. Active hepatitis B (HBV) or hepatitis C (HCV) infection defined as:

What this trial measures

  • Dose-limiting toxicities (DLTs)Up to 28 days after the first dose of study therapy

    Incidence and nature of DLTs

  • Adverse events (AEs)From Day 1 until up to 30 days after last dose of study drug.

    Incidence and severity of treatment-emergent (TE) and treatment-related adverse events (TRAEs) and Seious Adverse Events (SAEs).

  • Laboratory abnormalitiesFrom Day 1 until up to 30 days after last dose of study drug.

    Incidence of clinically significant laboratory abnormalities and changes in laboratory values (haematology, coagulation, serum chemistry and urinalysis).

  • Vital signsFrom Day 1 until up to 30 days after last dose of study drug.

    Clinically significant changes in vital signs, physical examination findings, and ECG findings.

  • Cardiac safetyFrom Day 1 until up to 30 days after last dose of study drug.

    Clinically significant reduction in LVEF (fallen by \> 10% to below the lower level of institutional normal (as assessed by ECHO).