Leronlimab Phase 1b/2 Trial Dosing Flowchart Pa

Leronlimab Phase 1b/2 Trial Dosing Flowchart

Patient Enrollment & Dose Escalation Plan:

First 3 patients

Starting dose: 350 mg leronlimab

42-day safety observation period

2 circulating tumor cell (CTC) tests performed

Next 3 patients

Starting dose: 525 mg leronlimab

42-day safety observation period

2 CTC tests performed

Next 3 patients

Starting dose: 700 mg leronlimab

42-day safety observation period

FDA Safety Review

After sufficient safety data, FDA authorized 700 mg as safe moving forward.

Patient Dosing After FDA Approval:

First 6 patients (350 mg and 525 mg cohorts):

Most likely remained on their original doses.

No clear memory or record of mandatory dose escalation to 700 mg.

Standard practice: unless protocol amendment and patient consent, doses typically stay stable.

New patients post-FDA approval:

Started directly on 700 mg leronlimab.

Current CRC Trial Comparison:

Start at lower doses (per protocol).

After Safety Committee review, escalate all patients to 700 mg if no safety concerns.

Visual Timeline:

Stage

Dose

Action After 42 Days

First 3 patients

350 mg

If safe, proceed to next dose level

Next 3 patients

525 mg

If safe, proceed to next dose level

Next 3 patients

700 mg

Continue at 700 mg

FDA Safety Clearance

-

Future patients start at 700 mg

Notes:

If patients showed good tolerability and no serious adverse events, the escalation proceeded.

Historical records or trial protocols would definitively confirm whether earlier patients escalated.

Summary:

It is most likely that the first 6 patients in the trial remained at their initial doses (350 mg or 525 mg) and only new patients after FDA clearance were started directly at 700 mg