Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery
Phase: PHASE1
Conditions: Parotid Neoplasm, Thyroid Neoplasms, Head and Neck Neoplasms, Surgery, Nerve Injury, Imaging
Sponsor: Alume Biosciences, Inc.

ALUME BIOSCIENCES, INC  
Protocol ALM-488-001 
Amendment 1, 24 August 2020  
 
  
 
 
 
 
 
 
PHASE 1/2 TRIAL OF ALM-488 IN PATIENTS UNDERGOING  
HEAD & NECK SURGERY 
 
PROTOCOL NUMBER: ALM-488-001 
 
 
 
 
Product:  
 
 
ALM-488 Sterile Solution  
 
Sponsor:  
 
 
Alume Biosciences, Inc. 
3210 Merryfield Row 
San Diego, CA 92121 
 
 
Date of Protocol:  
 
24 August 2020 
Protocol Version 
Issue Date 
Original Protocol 
26 April 2020 
Amendment 1 
24 August 2020 
 
 
 
 
 
 
 
 
 
Illuminating nerves, preserving  function.™ 
                  Precision Surgery.™  
  3210 Merryfield Row, San Diego, CA 92121 

ALUME BIOSCIENCES, INC  
Protocol ALM-488-001 
Amendment 1, 24 August 2020  
 
  
STUDY SUMMARY 
 
Name of Sponsor 
Alume Biosciences, Inc. 
Name of Investigational 
Product 
ALM-488 Sterile Solution  
Name of Active  
Ingredient 
ALM-488 
Protocol Title 
Phase 1/2 Trial Of ALM-488 In Patients Undergoing Head & Neck Surgery 
Protocol Number 
ALM-488-001 
Phase of Development 
Phase 1/2 
Study Duration 
18 months 
Study Center(s) 
Multi-center study (United States) 
Objectives 
Primary Objective: 
• 
To evaluate the safety of ALM-488 administered by intravenous (IV) 
infusion to patients undergoing head and neck surgery.  
 
Secondary Objectives: 
• 
To characterize the pharmacokinetics (PK) of ALM-488 in patients 
undergoing head and neck surgery. 
• 
To determine the recommended dose of ALM-488 needed to generate 
an adequate fluorescence signal in nerves.  
• 
To evaluate the effect of timing of administration of ALM-488 relative 
to surgery (e.g., up to 5 hours before surgery) on  adequacy of 
fluorescence nerve labeling. 
 
Diagnosis 
and 
Main 
Inclusion/Exclusion 
Criteria 
This study will be conducted in patients who are undergoing head and neck 
surgery. Each subject must meet the following criteria to be enrolled in this 
study: 
 
Inclusion: 
1. The subject has a neoplasm located in the head and neck including 
parotid neoplasm, thyroid neoplasm, squamous cell carcinoma or an 
unknown primary with metastases to the cervical lymph node(s) or is 
undergoing a neck dissection for head and neck neoplasm in an 
unknown location. 
2. The subject’s primary surgical treatment is by parotidectomy 
(superficial or total) or thyroidectomy (unilateral or bilateral) or 
cervical neck dissection, respectively. 
3. The subject can understand and is willing to sign a written informed 
consent document. 
4. The subject is a ≥18 years of age. 
5. The subject has a life expectancy of at least 6 months. 
6. The subject has a total bilirubin within institution’s normal laboratory 
limits. 
7. The subject has an aspartate aminotransferase (AST)/serum glutamic-
oxaloacetic transaminase (SGOT) and alanine aminotransferase 
(ALT)/serum 
glutamic-pyruvic 
transaminase 
(SGPT) 
within 
institution’s normal laboratory limits. 
8. The subject has adequate renal function, defined as glomerular 

ALUME BIOSCIENCES, INC  
Protocol ALM-488-001 
Amendment 1, 24 August 2020  
 
  
filtration rate (GFR) ≥ 60 mL/min/1.73 m2. 
9. The subject, if of childbearing potential, must have a negative urine 
or serum pregnancy test and be using a medically acceptable form of 
contraception (e.g., hormonal birth control, intrauterine devices, 
double-barrier method) or abstinence. The subject, if male, must 
use a medically acceptable form of contraception (e.g. condom) 
or abstinence. 
10. The subject is willing to remain on-site for approximately 23 hours 
after administration of ALM-488 or, if required, stay overnight after 
the surgical procedure. 
11. The subject plans to undergo head and neck surgery. 
 
Exclusion: 
1. The subject has had prior radiation or chemotherapy for any prior 
head and neck neoplasm. 
2. The subject has had open surgery in the ipsilateral head and neck 
within 1 year before administration of the investigational product (IP). 
3. The subject has abnormal cardiac rhythm not controlled with 
medication, history of stroke within 1 year, history of coronary events 
within 1 year, and/or heart failure within 1 year before administration 
of the IP. 
4. The subject has a history of drug-induced acute tubular necrosis. 
5. The subject has current evidence of renal disease defined as 
glomerular filtration rate (GFR) < 60 mL/min/1.73 m2. 
6. The subject has received a systemic investigational drug of any kind 
for any indication within 6 weeks before administration of the IP. 
7. The subject is pregnant or breastfeeding. 
8. The subject has unresolved acute toxicity from prior anti-cancer 
therapy, as graded by the National Cancer Institute (NCI) Common 
Terminology Criteria for Adverse Events (CTCAE) v5.0.  Alopecia, 
neuropathy ≤ Grade 2, and other non-acute toxicities are acceptable. 
9.  The subject has a history of fluorescein allergy. 
10.  The subject has a history of severe or steroid dependent asthma. 
11.  Any other criteria deemed by the PI that may prevent the patient from 
successfully completing the trial.