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RECORD 1: CLINICAL STUDY PROTOCOL — PROTOCOL VERSION 2.1
STUDY CODE: BV-402 (FICTIONAL STUDY IDENTIFIER)
DATE OF APPROVAL: MARCH 15, 2025
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SECTION 4: PARTICIPANT ELIGIBILITY CRITERIA

4.1 Inclusion Criteria
Candidates are eligible for enrollment only if all of the following criteria apply:
1. Age 18 years or older at the time of signing informed consent.
2. Histologically or cytologically confirmed metastatic solid tumor refractory to standard 
systemic therapy.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
4. Adequate bone marrow and organ function documented within fourteen (14) days prior to 
Cycle 1, Day 1:
   a. Absolute neutrophil count (ANC) >= 1,500/mcL.
   b. Platelet count >= 100,000/mcL.
   c. Total serum bilirubin <= 1.5 x upper limit of normal (ULN).
   d. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN.
   e. Serum creatinine <= 1.5 x ULN or calculated creatinine clearance >= 50 mL/min.
5. Prior systemic anti-cancer therapy, including targeted therapies and immunotherapy, must 
have concluded at least twenty-eight (28) days prior to Cycle 1, Day 1.

4.2 Exclusion Criteria
Candidates are excluded from enrollment if any of the following criteria apply:
1. Active or untreated central nervous system (CNS) metastases.
2. Uncontrolled intercurrent illness including active systemic bacterial or viral infection.
3. Known positive serology for Human Immunodeficiency Virus (HIV) or active Hepatitis B/C.
4. History of Grade 3 or higher immune-related pneumonitis or myocarditis from prior checkpoint 
inhibitors.

SECTION 5: INVESTIGATIONAL PRODUCT DOSAGE AND ADMINISTRATION

5.1 Dosing Schedule
Investigational product BV-402 will be administered as an intravenous (IV) infusion over 
60 minutes (+/- 10 minutes) on Day 1 of each fourteen (14) day treatment cycle (every two weeks, Q2W).
The starting dose for Cohort 1 is 150 mg. 

5.2 Dose Escalation and Dose Reductions
Intra-patient dose escalation to 225 mg is permitted after Cycle 3 if no Grade >= 2 
treatment-related adverse events are observed.
If dose reduction is required due to adverse drug reactions:
- First dose reduction (Level -1): 120 mg Q2W.
- Second dose reduction (Level -2): 90 mg Q2W.
- Patients requiring more than two dose reductions must be permanently discontinued from 
study treatment.

SECTION 7: SAFETY REPORTING AND REGULATORY MONITORING

7.3 Serious Adverse Event (SAE) Escalation
The Principal Investigator must report any Serious Adverse Event (SAE), whether deemed 
drug-related or unrelated, to the Sponsor Medical Monitor within seventy-two (72) hours of 
site awareness.
