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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Written informed consent prior to completing any study-specific procedure
  • Histologically- or cytologically-confirmed advanced/metastatic solid tumor or lymphoma that is refractory to standard therapies, or the patient refuses standard therapy
  • 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 prohibited medications (eg, concurrent anti-cancer therapy including other chemotherapy, radiation (local radiation for palliative care is permitted), hormonal anti-cancer treatment, biologic therapy, or immunotherapy) < 28 days prior to the first day of study treatment
  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mitesh Borad, M.D.

Closed for enrollment

Contact information:

Mitesh Borad M.D.

(480) 301-4800

Borad.Mitesh@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20542552

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