Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Patients With Advanced Malignancies

This is a Phase 1, open-label, multicenter, dose escalation study of intratumoral injections
of mRNA-2752 alone and in combination with intravenously administered immune checkpoint
blockade therapy in patients with histologically confirmed advanced or metastatic solid tumor
malignancies or lymphoma. The study consists of 3 dose escalation and dose confirmation parts
(Arms A, B, and C) followed by Dose Expansion parts in select indications.

Inclusion Criteria:

- Written informed consent prior to completing any study-specific procedure

- Histologically confirmed advanced or metastatic disease with at least 1 measurable
lesion as determined by RECIST v1.1 or Cheson 2016 criteria; and who has disease
progression after adequate standard of care therapies for metastatic disease that are
known to confer clinical benefit, is intolerant to treatment, or refuses standard
treatment (no limit to prior lines of therapy).

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

- Adequate hematological and biological function

- Has evidence of post-menopausal status or negative urinary or serum pregnancy test for
female pre-menopausal patients.

Exclusion Criteria:

- Has received prior systemic anti-cancer therapy including investigational agents
within 28 days of the start of study treatment.

- Has current or prior use of immunosuppressive medication within 14 days before the
first dose of study treatment.

- Active central nervous system tumors or metastases

- Active or prior documented autoimmune or inflammatory disorders

- History of primary immunodeficiency, allogenic solid organ transplantation, or
tuberculosis.

- Active infection including tuberculosis (clinical evaluation that includes clinical
history, physical examination and radiographic findings, and tuberculosis testing in
line with local practice), hepatitis B (known positive HBV surface antigen [HBsAg]
result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies).
Patients with a past or resolved HBV infection (defined as the presence of hepatitis B
core antibody [anti HBc] and absence of HBsAg) are eligible. Patients positive for
hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative
for HCV RNA.

- Uncontrolled intercurrent illness, including but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, cardiac arrhythmia, ILD, serious chronic gastrointestinal conditions
associated with diarrhea, or psychiatric illness/social situations that would limit
compliance with study requirement, substantially increase risk of incurring AEs, or
compromise the ability of the patient to give written informed consent.

- Is a female patient who is pregnant or breastfeeding or male or female patient of
reproductive potential who are not willing to employ effective birth control from
screening to 120 days after the last dose of study treatment.