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Anti-tumor antibiotic
AVA6000 for Cancer
Phase 1
Recruiting
Led By Chris Twelves, MD
Research Sponsored by Avacta Life Sciences Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological or cytological confirmation of a locally advanced (unresectable) and/or metastatic pancreatic (PDAC), CRC, NSCLC, HNSCC, CUP, ovarian, breast, soft tissue sarcoma, bladder, oesophageal, prostate, and biliary tract cancer, who have either relapsed or progressed on SoC treatment or are intolerant or nonamenable to SoC treatment
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year
Awards & highlights
No Placebo-Only Group
Summary
This trial tests AVA6000, a new drug that activates only in cancer cells, in patients with advanced or spreading tumors. The goal is to find the safest dose and see how well it works.
Who is the study for?
This trial is for adults over 18 with certain advanced or metastatic solid tumors (like breast, ovarian, bladder cancer) that have not responded to standard treatments. Participants must be in good physical condition with a life expectancy of more than 12 weeks and have recovered from previous treatments' side effects.
What is being tested?
AVA6000, a new drug given through the vein, is being tested on patients with FAP-positive tumors. The study has two parts: first finding the right dose and then seeing how well it works at that dose in more people.
What are the potential side effects?
Specific side effects of AVA6000 are not listed but may include typical reactions to cancer drugs such as nausea, fatigue, blood count changes, and potential infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has returned or worsened after standard treatment, or I cannot tolerate the standard treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse events (AEs)
Cardiac safety
Dose-limiting toxicities (DLTs)
+2 moreSecondary study objectives
Area under the curve (AUC) of AVA6000 & Doxorubicin
Duration of Response (DoR)
Elimination half-life (t1/2) of AVA6000 & Doxorubicin
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: AVA6000 Phase 1b Dose ExpansionExperimental Treatment1 Intervention
Patients in this arm will receive AVA6000 at the recommended dose for expansion, until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, reaching maximum lifetime cumulative exposure to doxorubicin (or other anthracyclines), or death, whichever occurs first.
Group II: AVA6000 Phase 1a Dose Escalation Q3WExperimental Treatment1 Intervention
Patients in this arm will receive escalating doses of AVA6000 following a 3+3 design, Q3W until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, reaching maximum lifetime cumulative exposure to doxorubicin (or other anthracyclines), or death, whichever occurs first.
Group III: AVA6000 Phase 1a Dose Escalation Q2WExperimental Treatment1 Intervention
Patients in this arm will receive escalating doses of AVA6000 following a 3+3 design, Q2W until disease progression, unacceptable toxicities, withdrawal from treatment for other reasons, reaching maximum lifetime cumulative exposure to doxorubicin (or other anthracyclines), or death, whichever occurs first.
Find a Location
Who is running the clinical trial?
Avacta Life Sciences LtdLead Sponsor
Chris Twelves, MDPrincipal InvestigatorSt James's University Hospital, Leeds, UK