Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Maligna… (NCT03739931) | Clinical Trial Compass
CompletedPhase 1
Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies
United States134 participantsStarted 2018-11-27
Plain-language summary
The clinical study will assess the safety and tolerability of escalating intratumoral doses of mRNA-2752 in participants with relapsed/refractory solid tumor malignancies or lymphoma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Cheson 2016 criteria
* Dose Escalation/Confirmation:
o 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)
* Dose Expansion:
* Group 1 Triple negative breast cancer: Must have objective evidence of disease progression during or following at least one prior line of therapy for metastatic or locally advanced disease. Enrollment to Stage 3 of this cohort will include participants who have previously progressed on prior immune checkpoint blockade or participants with programmed death-ligand 1 (PD-L1) negative tumor based on archival tissue (if available).
* Group 2 Head and neck squamous cell carcinoma: Must have objective evidence of disease progression during or following platinum-containing chemotherapy as well as a PD-1/L1 therapy
* Group 3 Non-Hodgkin's lymphoma: Must have objective evidence of disease progression and have received 2 or more prior lines of therapy. Participants with large B-cell lymphoma must have received prior anthracycline containing chemotherapy.
* Group 4 Urothelial cancer, first line: Must be cispla…
What they're measuring
1
Number of Participants with Dose Limiting Toxicities (DLTs)
Timeframe: Up to Day 28
2
Number of Participants with Adverse Events (AEs)
Timeframe: Up to 27 months
3
Arm B: Overall Response Rate (ORR): Percentage of Participants with Tumor Response (Partial or Complete) Based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) in Cutaneous Melanoma