Dose Escalation and Efficacy Study of mRNA 2416 for Intratumoral Injection to Patients With Advanced Malignancies



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:2/8/2019
Start Date:August 9, 2017
End Date:October 2020
Contact:Moderna Clinical Trials
Email:clinicaltrials@modernatx.com
Phone:855-663-6762

Use our guide to learn which trials are right for you!

A Phase 1/2, Open-Label, Multicenter, Dose Escalation and Efficacy Study of mRNA 2416, a Lipid Nanoparticle Encapsulated mRNA Encoding Human OX40L, for Intratumoral Injection to Patients With Advanced Malignancies

This clinical study will assess the safety and tolerability of escalating intratumoral doses
of mRNA 2416 in patients with relapsed/refractory solid tumor malignancies or lymphoma, as
well as the objective response rate (ORR) of mRNA-2416 monotherapy in ovarian cancer based on
Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

This is a first-in-human, Phase 1, open-label, multicenter, dose escalation and efficacy
study designed to determine the safety and tolerability of repeated intratumoral injections
of mRNA 2416 in patients with advanced relapsed/refractory solid tumor malignancies or
lymphoma and to assess the ORR of mRNA-2416 monotherapy in ovarian cancer based on RECIST
v1.1. The study will include 3 dosing periods: a Dose Escalation period in non-visceral
lesions followed by a Dose Confirmation period in visceral lesions and an Expansion period at
the MTD/RDE as determined by the Dose Escalation period.

Inclusion Criteria:

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

- Dose Escalation period: histologically- or cytologically-confirmed advanced/metastatic
solid tumor or lymphoma by pathology report and who has received, or been intolerant
to, all approved therapies

- Dose Confirmation and Expansion periods: Histologically or cytologically confirmed
diagnosis of: epithelial cancer of the ovary, fallopian tube, or peritoneum which is
platinum resistant or platinum refractory. Patients must have received at least 2
prior lines of therapy. Patients with known BRCA mutation positive must have been
treated with and progressed on at least 1 prior PARPi (poly(ADP-ribose) polymerase
inhibitor)

- All lesion(s) targeted for the initial injection must be ≥ 0.5 cm on longest diameter,
be at least 5 mm thick, and have distinct borders based on exam or imaging, not close
to critical structures such as major vessels, nerves, or airways

- Patients must have measurable disease as determined by RECIST v1.1 (solid tumors) or
Cheson 2014 criteria (lymphomas)

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

- Adequate hematological and biological function

- Female patients of childbearing potential must have a negative serum pregnancy test

- Male and female patients must agree to use a highly reliable method of birth control

Exclusion Criteria:

- Active central nervous system tumors or metastases

- Treatment with chemotherapy, radiation (local radiation for palliative care is
permitted), hormonal anti-cancer treatment, or biologic therapy <14 days prior to the
first day of study treatment (Cycle 1 Day 1 [C1D1]). Treatment with any other
investigational agent or treatment with any anti-cancer monoclonal antibody,
immunostimulant, or vaccine <28 days prior to C1D1

- Reversible toxicities from prior cancer therapy that have not recovered to Grade 1 or
baseline

- Active or prior autoimmune disorder within the past 2 years

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

- Any plan to receive a live attenuated vaccine during study treatment

- History of human immunodeficiency virus infection (testing is not required)

- Active/chronic hepatitis B or C

- Females who are pregnant or breastfeeding
We found this trial at
6
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Salt Lake City, Utah 84112
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials