Dose Escalation: Relapsed/Refractory Solid Tumor Malignancies or LymphomaPhase 1NCT03739931
Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies
A Phase 1 study testing mRNA-2752 and Durvalumab in people with Dose Escalation: Relapsed/Refractory Solid Tumor Malignancies or Lymphoma and Dose Expansion: Triple Negative Breast Cancer, HNSCC, Non-Hodgkins, Urothelial Cancer, Immune Checkpoint Refractory Melanoma, and NSCLC Lymphoma, run by ModernaTX, Inc. at 24 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dose Escalation: Relapsed/Refractory Solid Tumor Malignancies or Lymphoma, Dose Expansion: Triple Negative Breast Cancer, HNSCC, Non-Hodgkins, Urothelial Cancer, Immune Checkpoint Refractory Melanoma, and NSCLC Lymphoma
- What is being tested?
- mRNA-2752 and Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 24 sitesin 3 countries
- Study dates
- 27 Nov 2018to 1 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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 cisplatin ineligible and PD-L1 negative
- Group 5 Urothelial cancer: Must have objective evidence of disease progression during or following platinum-containing chemotherapy
- Group 6 Cutaneous melanoma: Must be refractory to immune checkpoint blockade in the primary or secondary acquired resistance setting.
- Group 7 Non-small cell lung cancer, primary refractory or secondary acquired resistance to immune checkpoint blockade.
- Dose Exploration:
- o Newly diagnosed resectable, BRAF wild-type, Stage IIIB/C/D and Stage IV cutaneous melanoma with clinically evident lymph node involvement in the neoadjuvant setting.
- Has a tumor lesion amenable to biopsy and must be willing to provide the baseline and on-treatment tumor biopsy samples if medically feasible. For participants with only 1 lesion amenable to injection, biopsy, and RECIST assessment, that lesion must be ≥2 centimeters (cm)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
- Has a body weight of >30 kilograms (kg)
- Adequate hematological and biological function
- Has evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal participants
- Treatment Arm B and Arm C: Clinical euthyroid status. Participants with clinically stable hypothyroidism, on adequate thyroid supplementation, are permitted on study.
Who cannot join
- Has received prior systemic anticancer therapy including investigational agents within 5 half-lives or 28 days of the start of study treatment, whichever is shorter. Participants enrolled to Arm C may not have received any previous anti-cancer therapy, immune therapy, radiotherapy, or investigational agents.
- Has received prior radiotherapy within 14 days before the first dose of study treatment. Participants enrolled to Arm C may not have had prior anticancer therapy including radiotherapy.
- Has received a live vaccine within 30 days before the first dose of study treatment
- Has current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment
- Have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment.
- Requires active systemic anticoagulation at the time of intratumoral injection or biopsy
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- Active central nervous system tumors or metastases
- Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and protocol defined laboratory values
- Participants with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Medical Monitor.
- Participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Medical Monitor.
- Any 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). Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease (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 participant to give written informed consent
- Has active GI bleeding or hemoptysis or history of bleeding disorder
- Is a female participant who is pregnant or breastfeeding or male or female participant of reproductive potential who are not willing to employ effective birth control from screening to 120 days after the last dose of study treatment
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
United States16 sites
University of Colorado Denver
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cancer Center at Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
The University of Chicago Medicine
Chicago, Illinois, 60637
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Henry Ford Hospital
Detroit, Michigan, 48202
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale Cancer Center
New Haven, Connecticut, 06510
NYU Langone Medical Center
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Oregon Health and Science University
Portland, Oregon, 97239-3011
James P. Wilmot Cancer Center
Rochester, New York, 14642
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
Providence St. John's Health Center
Santa Monica, California, 90404
Sarah Cannon Research Institute at Florida Cancer Specialists
Sarasota, Florida, 34232
Australia4 sites
Alfred Health
Melbourne, 3004
One Clinical Research Perth
Nedlands, Western Australia, 6009
Westmead Hospital
Westmead, 2145
Melanoma Institute of Australia
Wollstonecraft
Israel4 sites
Rambam Medical Center
Haifa, 3109601
Rabin Medical Center
Petah Tikva, 4941492
Chaim Sheba Medical Center
Ramat Gan, 5224213
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
About this study
Official title: A Phase 1, Open-Label, Multicenter, Dose Escalation Study of mRNA-2752, a Lipid Nanoparticle Encapsulating mRNAs Encoding Human OX40L, IL-23, and IL-36γ, for Intratumoral Injection Alone and in Combination With Immune Checkpoint Blockade
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.
Read the detailed description
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 participants with histologically confirmed advanced or metastatic solid tumor malignancies or lymphoma. The study consists of Dose Escalation and Dose Confirmation Parts, which will occur in Arm A and Arm B, followed by a Dose Expansion Part, which will occur in Arm B, and a Dose Exploration in Arm C as a neoadjuvant therapy for cutaneous melanoma.
Participants in Arm A and in Arm B will be enrolled into the Dose Escalation Part and the doses of mRNA-2752 will be administered in a dose escalation regimen until a maximum tolerated dose (MTD) or a recommended dose for expansion (RDE) is identified. When the MTD/RDE is identified, participants with solid tumors or lymphoma with visceral lesions may be enrolled into the Dose Confirmation Part to confirm that the dose is also appropriate for this subgroup.
- Conditions
- Dose Escalation: Relapsed/Refractory Solid Tumor Malignancies or Lymphoma, Dose Expansion: Triple Negative Breast Cancer, HNSCC, Non-Hodgkins, Urothelial Cancer, Immune Checkpoint Refractory Melanoma, and NSCLC Lymphoma
- Being tested
- mRNA-2752, Durvalumab
- Keywords
- mRNA-2752, OX40L, IL-23, IL-36γ, Intratumoral injection
- Medical subject headings
- Lymphoma, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-2752Biological
Solution for intratumoral injection
DurvalumabBiological
Solution for infusion after dilution
| Study group | Role | What they receive |
|---|---|---|
| Arm A: mRNA-2752 | Experimental | Participants will be administered mRNA-2752 at an applicable dose as monotherapy. Receives: Biological: mRNA-2752 |
| Arm B: mRNA-2752 + Durvalumab | Experimental | Participants will be administered mRNA-2752 at an applicable dose in combination with durvalumab. Receives: Biological: mRNA-2752; Biological: Durvalumab |
| Arm C: mRNA-2752 Alone or mRNA-2752 + Durvalumab | Experimental | Participants will be administered mRNA-2752 at an applicable dose as monotherapy or in combination with durvalumab. Receives: Biological: mRNA-2752; Biological: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose Limiting Toxicities (DLTs)
Measured: Up to Day 28
Number of Participants with Adverse Events (AEs)
Measured: Up to 27 months
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
Measured: Up to 2 years
Secondary outcomes (2)
ORR: Percentage of Participants with Tumor Response (Partial or Complete) Based on RECIST v1.1 and modified RECIST (iRECIST), and Cheson and Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) for Participants With Lymphoma
Measured: Up to 2 years
Pharmacokinetics: Maximum Observed Concentration (Cmax)
Measured: Predose, immediately after injection, and 15 minutes up to 168 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start27 Nov 2018
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dose Escalation: Relapsed/Refractory Solid Tumor Malignancies or LymphomaStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739931
- Sponsor's protocol ID
- mRNA-2752-P101
- Other IDs
- 2022-001597-55
- Status last verified
- Aug 2025
- First submitted
- 8 Nov 2018
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Srikrishna D, Sachsenmeier K. We need to bring R0 < 1 to treat cancer too. Genome Med. 2021 Jul 26;13(1):120. doi: 10.1186/s13073-021-00940-9.
PubMed 34311780
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multicenter, Dose Escalation Study of mRNA-2752, a Lipid Nanoparticle Encapsulating mRNAs Encoding Human OX40L, IL-23, and IL-36γ, for Intratumoral Injection Alone and in Combination With Immune Checkpoint Blockade
- ClinicalTrials.gov ID
- NCT03739931
- Acronym / sponsor ID
- mRNA-2752-P101
- Conditions
- Dose Escalation: Relapsed/Refractory Solid Tumor Malignancies or Lymphoma, Dose Expansion: Triple Negative Breast Cancer, HNSCC, Non-Hodgkins, Urothelial Cancer, Immune Checkpoint Refractory Melanoma, and NSCLC Lymphoma
- Keywords
- mRNA-2752, OX40L, IL-23, IL-36γ, Intratumoral injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 participants with histologically confirmed advanced or metastatic solid tumor malignancies or lymphoma. The study consists of Dose Escalation and Dose Confirmation Parts, which will occur in Arm A and Arm B, followed by a Dose Expansion Part, which will occur in Arm B, and a Dose Exploration in Arm C as a neoadjuvant therapy for cutaneous melanoma.
Participants in Arm A and in Arm B will be enrolled into the Dose Escalation Part and the doses of mRNA-2752 will be administered in a dose escalation regimen until a maximum tolerated dose (MTD) or a recommended dose for expansion (RDE) is identified. When the MTD/RDE is identified, participants with solid tumors or lymphoma with visceral lesions may be enrolled into the Dose Confirmation Part to confirm that the dose is also appropriate for this subgroup.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: mRNA-2752 | Experimental | Biological: mRNA-2752Participants will be administered mRNA-2752 at an applicable dose as monotherapy. |
| Arm B: mRNA-2752 + Durvalumab | Experimental | Biological: mRNA-2752, Biological: DurvalumabParticipants will be administered mRNA-2752 at an applicable dose in combination with durvalumab. |
| Arm C: mRNA-2752 Alone or mRNA-2752 + Durvalumab | Experimental | Biological: mRNA-2752, Biological: DurvalumabParticipants will be administered mRNA-2752 at an applicable dose as monotherapy or in combination with durvalumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
Key exclusion criteria (16 listed)
- Has received prior systemic anticancer therapy including investigational agents within 5 half-lives or 28 days of the start of study treatment, whichever is shorter. Participants enrolled to Arm C may not have received any previous anti-cancer therapy, immune therapy, radiotherapy, or investigational agents.
- Has received prior radiotherapy within 14 days before the first dose of study treatment. Participants enrolled to Arm C may not have had prior anticancer therapy including radiotherapy.
- Has received a live vaccine within 30 days before the first dose of study treatment
- Has current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment
- Have major surgical procedures within 28 days or non-study-related minor procedures within 7 days before the first dose of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-2752Solution for intratumoral injection | Biological | Arm A: mRNA-2752, Arm B: mRNA-2752 + Durvalumab, Arm C: mRNA-2752 Alone or mRNA-2752 + Durvalumab |
| DurvalumabSolution for infusion after dilution | Biological | Arm B: mRNA-2752 + Durvalumab, Arm C: mRNA-2752 Alone or mRNA-2752 + Durvalumab |
Primary outcome
Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Up to Day 28
Number of Participants with Adverse Events (AEs)
Time frame: Up to 27 months
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
Time frame: Up to 2 years
2 secondary outcomes
ORR: Percentage of Participants with Tumor Response (Partial or Complete) Based on RECIST v1.1 and modified RECIST (iRECIST), and Cheson and Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) for Participants With Lymphoma
Time frame: Up to 2 years
Pharmacokinetics: Maximum Observed Concentration (Cmax)
Time frame: Predose, immediately after injection, and 15 minutes up to 168 hours postdose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Derived from this study: PubMed 34311780Srikrishna D, Sachsenmeier K. We need to bring R0 < 1 to treat cancer too. Genome Med. 2021 Jul 26;13(1):120. doi: 10.1186/s13073-021-00940-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mRNA-2752 and Durvalumab in people with Dose Escalation: Relapsed/Refractory Solid Tumor Malignancies or Lymphoma and Dose Expansion: Triple Negative Breast Cancer, HNSCC, Non-Hodgkins, Urothelial Cancer, Immune Checkpoint Refractory Melanoma, and NSCLC Lymphoma, run by ModernaTX, Inc. at 24 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Australia, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose Limiting Toxicities (DLTs) (time frame: Up to Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03739931, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.