A monitoring visit report, drafted by software.

Visit Summary²

The monitoring visit (VST-002) was conducted at Site-014 · Boston General on 2026-05-12, as scheduled, for the AXM-203 v3.2 (Rigora Clinical Phase II — Oncology) protocol. The purpose of this visit was to review the conduct of the study, verify source data, and ensure compliance with the protocol and ICH-GCP guidelines. Source data verification and source data review were completed for all four enrolled subjects; findings and the required site actions are documented below.³

Source Data Verification (SDV) Findings

A total of 28 SDV checks were performed during this visit. The findings include:

• Exact matches for various parameters such as weight, blood pressure, heart rate, and laboratory values for subjects PT-0142, PT-0276, PT-0411, and PT-0507.
• Mismatches and minor discrepancies were identified, including but not limited to:
• PT-0142: ANC (0.8 ×10⁹/L) below the protocol threshold (§1.3 requires ≥1.5), indicating possible Grade 3 neutropenia.⁴
• PT-0276: Systolic BP (mean 198 mmHg) exceeds the §4.1 stopping threshold, and a dose of 200 mg was recorded without a documented dose reduction.
• PT-0411: Missing RECIST tumor assessment, which was due during this visit per §3.2.
• PT-0507: ALT (173 U/L) exceeds the §1.3 hepatic threshold (2.5× ULN).

Source Data Review (SDR) Findings & Protocol Deviations⁵

The SDR identified 5 anomalies, including:

• PT-0276: Critical eligibility issue due to sustained SBP exceeding the §4.1 stopping threshold, and a major dose deviation without a documented dose-reduction event.
• PT-0142: Major lab anomaly due to Grade 3 neutropenia (ANC 0.8 ×10⁹/L), breaching the protocol threshold.
• PT-0507: Minor lab anomaly due to ALT exceeding the hepatic threshold.
• PT-0411: Informational issue regarding the missing RECIST tumor assessment.

Open Queries

The following queries are open and require resolution:

• PT-0142: ANC value and potential Grade 3 neutropenia implications.
• PT-0276: Dose discrepancy and potential protocol deviation.
• PT-0411: Missing RECIST assessment.
• PT-0507: Elevated ALT and implications for study continuation.

Action Items

1. Site: Verify and document the rationale for the dose discrepancy in PT-0276 by [VERIFY: due date].⁶
2. Site: Conduct and document the missing RECIST assessment for PT-0411 at the next scheduled tumor-assessment window (Cycle 3 Day 1), no later than 2026-05-26.
3. Site: Review and address the elevated ALT in PT-0507, considering the implications for study continuation by [VERIFY: due date].
4. CRA: Follow up on the open queries and ensure resolution by [VERIFY: due date].
5. CRA: Escalate the sustained systolic BP finding for PT-0276 to the medical monitor within 24 hours and document the outcome in the visit file.

Next Visit Plan

The next monitoring visit will be scheduled based on the study's monitoring plan and will focus on:

• Resolving the open queries and action items from this visit.
• Continuing source data verification and review to ensure protocol compliance and data integrity.
• Reviewing the overall conduct of the study at the site to ensure adherence to ICH-GCP guidelines and the protocol. [VERIFY: specific dates and details to be confirmed].