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Anti-tumor antibiotic

AVA6000 Phase 1a for Soft Tissue Sarcoma

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

Study Summary

This trial will test the safety, effectiveness, and how the body processes a new drug for patients with cancer. It'll use a 3+3 design to find the maximum tolerated dose and recommended phase II dose.

Eligible Conditions
  • Soft Tissue Sarcoma
  • Head and Neck Cancers
  • 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 weeks
Treatment ~ Varies
Follow Up ~up to one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum-tolerated dose (MTD) or Recommended Phase 2 dose (RP2D)
Number of participants with dose-limiting toxicities (DLTs)
Percentage of patients with Adverse Events (AEs) at RP2D AVA6000 dose level in tumour-specific expansion arms.
+1 more
Secondary outcome measures
Area under the concentration versus time curve (AUC) of AVA6000 & Doxorubicin
Duration of Response (DoR)
Elimination half-life (t1/2) of AVA6000 & Doxorubicin
+5 more

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.

Find a Location

Who is running the clinical trial?

Avacta Life Sciences LtdLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent might AVA6000 Phase 1a be a hazard to those taking part in the trial?

"AVA6000 Phase 1a scored a 1 on our safety scale due to the limited evidence of its efficacy and safety in this early stage clinical trial."

Answered by AI

How many individuals are presently under scrutiny for this clinical investigation?

"Affirmative. Clinicaltrials.gov data displays that this examination, which was initially publicized on July 16th 2021, is still recruiting participants. 80 volunteers need to be enlisted from 8 distinct medical centres."

Answered by AI

What percentage of hospitals in this state are conducting this research?

"Currently, the trial is accepting participants from 8 locations across the world; Seattle, Newcastle upon Tyne and Glasgow feature prominently but there are 5 other sites available. Thus, it is advised that prospective enrollees pick a nearby clinical centre to cut down on travel needs."

Answered by AI

Are there still opportunities for patients to participate in this clinical exploration?

"Affirmative. Information available on clinicaltrials.gov states that this medical trial began recruiting patients on July 16th 2021 and is still actively looking for participants, with a total of 80 needed from 8 distinct sites."

Answered by AI

What is the purpose of this investigation?

"The primary objective of this trial, evaluated over a three-week period, is to assess the percentage of patients with Dose-Limiting Toxicities (DLTs) induced by AVA6000. Secondary objectives include assessing Duration of Response (DoR), Maximum Drug Concentration (Cmax) for AVA6000 and doxorubicin, as well as Renal Clearance (CLr) values for both molecules after administration in Cycle 1 and 2."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
The Christie NHS Foundation Trust
The Freeman Hospital, Newcastle-upon-Tyne NHS Foundation Trust
Weston Park Cancer Centre, Sheffield Teaching Hospitals NHS Foundation Trust
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What state do they live in?
California
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours
2021. "A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04969835.
~21 spots leftby Apr 2025
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