A monitoring visit report, drafted by software.

1. Visit Summary¹

Overall Site Assessment: Site-014 demonstrates adequate administrative and data-entry practices across the majority of reviewed records; 23 25 of 28 SDV data points were verified as exact source-to-eCRF matches with no discrepancy. However, this visit has uncovered a pattern of clinically significant findings across three of the four subjects reviewed that requires immediate attention prior to the next visit. PT-0276 presents a critical safety concern: three sequential systolic blood pressure readings averaging 198 mmHg exceed the §4.1 stopping threshold, and a dose of 200 mg was administered without any documented dose-reduction event, breaching the §2.1 starting-dose requirement. PT-0142 has a confirmed ANC of 0.8 ×10⁹/L, consistent with Grade 3 neutropenia, which breaches the §1.3 laboratory eligibility threshold. PT-0507 has an ALT of 4.2× ULN, exceeding the §1.3 hepatic hold criterion of 2.5× ULN; this finding is currently in a disputed disposition and requires prompt resolution with the site. Additionally, PT-0411's required RECIST tumor assessment was neither performed nor formally documented as a deviation. The site must address all four deviation records and confirm subject safety management measures in writing before the next monitoring visit. Escalation to the Medical Monitor and Sponsor Safety team is recommended for PT-0276 and PT-0142 without delay.

2. Source Data Verification (SDV) Findings²

The three discrepancies above have each been queried in the EDC system. Full query text and query numbers are recorded in the system audit trail; confirm query reference numbers for each of the three items above.

Of the remaining 25 SDV records reviewed, all were confirmed as exact source-to-eCRF matches and accepted without action. These cover visit dates for PT-0142, PT-0276, PT-0411, and PT-0507; weight, systolic BP, diastolic BP, heart rate, hemoglobin, platelets, ANC, and dose for PT-0142; ECG performance, cycle/day, concomitant medications, dose, and adherence diary for PT-0276 and PT-0411; and ALT, AST, total bilirubin, and dose for PT-0507. Although these records matched, several of the underlying source values carry clinical significance that is addressed separately in Section 3 below.

Note on PT-0276 — Dose 200 mg: The dose field (source = 200 mg, eCRF = 200 mg) is an exact match and therefore carries no SDV discrepancy; however, because §2.1 specifies a starting dose of 240 mg and no dose-reduction event has been documented, this constitutes a protocol deviation and is captured in Section 3.

Note on PT-0411 — RECIST Assessment: The source field is blank and the eCRF entry is absent; accordingly, there is no source-to-eCRF transcription error. The clinical significance of the missing assessment is addressed as a protocol deviation in Section 3.

3. Source Data Review (SDR) Findings & Protocol Deviations³

Clinical Significance:

PT-0276 presents the most urgent patient safety concern identified during this visit. Three sequential systolic BP measurements of 198, 196, and 201 mmHg were recorded in source, yielding a mean of 198 mmHg. This meets or exceeds the §4.1 stopping criterion, and the subject's continued participation without a documented hold decision represents a critical protocol deviation. Independently, the administration of 200 mg in the absence of any dose-modification record is a major deviation under §2.1. whether the dose reduction and the elevated BP are clinically related, and whether a Medical Monitor notification has been initiated. Both findings must be escalated to the Sponsor Medical Monitor immediately.

PT-0142 has an ANC of 0.8 ×10⁹/L, which is 0.7 units below the §1.3 minimum threshold of 1.5 ×10⁹/L and is clinically consistent with Grade 3 neutropenia. The current treatment status of this subject and any dose-hold or dose-modification decisions must be confirmed and documented. whether the site has initiated a neutropenia management plan, whether a SAE report is required, and current ANC trend.

PT-0507 has an ALT of 173 U/L (4.2× ULN), which exceeds the §1.3 hepatic hold criterion. The concurrently rising AST (2.1× ULN, still within window but trending upward from baseline) heightens concern for emerging hepatotoxicity. The site's dispute of the minor deviation classification must be resolved promptly; the CRA should obtain the site's written rationale and escalate to the Medical Monitor if the dispute cannot be resolved at site level. site's basis for disputing the deviation, current subject clinical status, and whether a dose hold has been enacted.

PT-0411 did not undergo the RECIST tumor assessment required at this visit per §3.2. No scan was documented in either source or eCRF, and no protocol deviation form was filed. While this finding is classified as informational, the imaging gap may affect the subject's evaluability for efficacy endpoints. reason the scan was not performed, whether it has been rescheduled, and whether a revised deviation form is being prepared.

4. Open Queries⁴

5. Action Items

6. Status of Previous Open Action Items⁵

No open action items from a previous monitoring visit were provided in the source input for this report. [VERIFY: confirm whether VST-001 generated any open action items that remain outstanding; if so, restate each verbatim, assess current status as resolved / still open / escalate, and append to this section before finalising the report.] VST-001 generated no open action items; there are no outstanding items carried into this visit.

7. Next Visit Plan

The next monitoring visit at Site-014 should be scheduled at an interval appropriate to the elevated risk profile identified during VST-002. confirm next visit date and whether an earlier unscheduled visit is warranted given the critical findings for PT-0276 and PT-0142.

The following areas must be prioritised during the next visit:

1. PT-0276 safety follow-up: Verify that all three sequential SBP readings have been entered in the eCRF, that a Medical Monitor notification is on file, and that the dose-reduction rationale and supporting documentation have been completed. Review any ongoing blood pressure monitoring records added since 2026-05-12.

1. PT-0276 dose-modification documentation: Confirm that a protocol deviation form and retrospective dose-reduction record are filed and accepted by the Sponsor; verify there are no additional undocumented dose changes in prior cycles.

1. PT-0142 neutropenia management: Review updated ANC values, confirm the subject's current treatment status, and verify that all required toxicity management and dose-modification documentation is complete. Assess whether SAE reporting obligations were met.

1. PT-0507 ALT / hepatic safety: Confirm resolution of the disputed deviation, review repeat liver function test results obtained after 2026-05-12, and assess whether the dose-hold criterion was triggered and appropriately managed per §1.3. Monitor AST trend.

1. PT-0411 RECIST imaging: Verify that the missed tumor assessment has been rescheduled and performed, that source imaging documentation is on file, and that the protocol deviation form has been completed and accepted.

1. Omeprazole concomitant medication query: Confirm that the eCRF has been updated for PT-0507 and that the §2.3 food-separation requirement is being followed and documented.

1. General SDV completeness: Extend SDV coverage to any subjects not reviewed during VST-002 and to new data entered since this visit, with particular attention to laboratory values, dose administration records, and concomitant medications across all active subjects.

1. Regulatory and essential documents: Review the site file for currency of protocol amendments, IRB/IEC correspondence, investigator CVs, and laboratory normal ranges. whether any protocol amendments or IEC reapprovals are pending since the last site file review.

8. Signature⁶