AVA6000 Phase 1a for Colorectal Cancer

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

Colorectal Cancer
Soft Tissue Sarcoma
Esophageal Cancer
Prostate Cancer
Head and Neck Cancers
Breast Cancer
Lung Cancer
Cancer of Unknown Primary
Ovarian Cancer
Pancreatic Cancer
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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year for reporting.

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 more

Awards & 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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