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Anti-tumor antibiotic
AVA6000 Phase 1a for Head and Neck Cancers
Phase 1
Recruiting
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
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.
Eligible Conditions
- Head and Neck Cancers
- Soft Tissue Sarcoma
- Breast Cancer
- Colorectal Cancer
- Ovarian Cancer
- Esophageal Cancer
- Prostate Cancer
- Pancreatic Cancer
- Non-Small Cell Lung Cancer
- Cancer of Unknown Primary
- Bladder Cancer
- Biliary Tract Cancer
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.Secondary study objectives
Area under the concentration versus time 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
2Treatment groups
Experimental Treatment
Group I: AVA6000 Phase 1bExperimental Treatment1 Intervention
Patients in Phase Ib will receive the RP2D dose of AVA6000, once every 3 weeks (Q3W) starting on Cycle 1, Day 1 (C1D1), 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. One to three tumour types will be selected based on the assessment of Phase 1a data.
Group II: AVA6000 Phase 1aExperimental Treatment1 Intervention
Patients in Phase Ia will receive escalating doses of AVA6000 following a 3+3 design, commencing with a starting dose of 80mg/m2, once every 3 weeks (Q3W) starting on Cycle 1, Day 1 (C1D1), 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.
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Who is running the clinical trial?
Avacta Life Sciences LtdLead Sponsor
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