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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.

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Who is running the clinical trial?

Avacta Life Sciences LtdLead Sponsor
~21 spots leftby May 2025
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