RE: Early Data9 Apr 2026 09:23
Grok queery:
Avacta’s FOCUS-01 Phase 1 trial of AVA6103 (also called FAP-Exd, a sustained-release pre|CISION® peptide drug conjugate delivering the topoisomerase I inhibitor exatecan) is using the Bayesian Optimal Interval (BOIN) design for its dose-escalation portion.
The two arms of the trial are dosing every 2 weeks and every 3 weeks.
What will be the frequency of imaging cancer sites
The FOCUS-01 trial (NCT07454642) evaluates preliminary efficacy of AVA6103 using RECIST 1.1 criteria for tumor response assessments. This includes Objective Response Rate (ORR), Duration of Response (DoR), and Progression-Free Survival (PFS), all defined per RECIST version 1.1.
However, the publicly available information on clinicaltrials.gov and Avacta’s announcements does not specify an exact frequency or schedule for imaging (e.g., CT scans, MRI, or other radiological evaluations) of cancer sites. No details appear on the timing of baseline scans, on-treatment scans, or follow-up assessments beyond the general time frame “from Day 1 until up to 30 days after last dose of study drug.”
Typical Practice in Similar Phase 1 Oncology Trials
In early-phase dose-escalation trials like this (especially those with parallel Q2W and Q3W arms), tumor imaging is usually performed at these approximate intervals, though the exact protocol may vary:
Baseline — Within a short window before starting treatment (e.g., within 28 days of Cycle 1 Day 1) to establish measurable disease per RECIST 1.1.
On-treatment — Every 6–9 weeks (or every 2–3 cycles), aligned with the dosing schedule. For the Q3W arm, this often means imaging every 9 weeks (after 3 cycles); for the Q2W arm, it could align to every 6–8 weeks. This allows early detection of response or progression without overly frequent scans.
Confirmation — Any partial or complete response typically requires a confirmatory scan at least 4 weeks later.
End of treatment/follow-up — Additional imaging at discontinuation and during survival follow-up if applicable.
These intervals balance the need to monitor for preliminary signals of activity (important in Phase 1 for deciding dose expansion) with patient burden and radiation exposure. The trial also allows optional on-treatment tumor biopsies, which can complement imaging for pharmacodynamic insights.
The two dosing arms (Q2W and Q3W) run independently, so imaging frequency is likely standardized across both rather than differing by arm, but it would be calibrated to the cycle length for practicality.
Why the Exact Frequency Isn’t Publicly Detailed Yet
Phase 1 protocols often keep detailed visit and assessment schedules in the full protocol document (not fully posted on clinicaltrials.gov). Avacta has emphasized safety, pharmacokinetics, and preliminary efficacy in their updates, with initial data expected in the second half of 2026. More granular details on imaging may become available in future publications.
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