Advanced Solid TumorsPhase 1NCT06880549
A Study of mRNA-4106 or mRNA-4200 Administered Alone or in Combination With Anti-Cancer Agents in Participants With Solid Tumors
A Phase 1 study testing mRNA-4106, Pembrolizumab and mRNA-4200 in people with Advanced Solid Tumors, run by ModernaTX, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of mRNA-4106 monotherapy and of mRNA-4200 in combination with checkpoint inhibitor therapy in participants with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- mRNA-4106, Pembrolizumab and mRNA-4200
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Mar 2025to 3 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Arm 1: Histologically confirmed advanced or metastatic cancer (cutaneous melanoma, non-small cell lung cancer [NSCLC], hepatocellular carcinoma [HCC], esophageal carcinoma, head and neck squamous cell carcinoma [HNSCC], colon/rectal adenocarcinomas, urothelial/bladder, gastric, ovarian, cervical, and endometrial carcinomas) with measurable disease as determined by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1) and have completed or refused all standard therapies (no limit to prior lines of therapy). Participants must have a tumor lesion amenable to biopsy, or alternatively archival tumor tissue is acceptable as long as the collection date is within one year of the enrollment date.
- Arm 2: Histologically confirmed advanced or metastatic cancer (cutaneous melanoma, NSCLC, esophageal carcinoma, HNSCC, urothelial/bladder carcinoma, gastric, colon/rectal adenocarcinomas, ovarian, cervical, and endometrial carcinomas [Note: HCC not included]) with measurable disease as determined by RECIST v1.1 and have completed or refused all standard therapies (no more than 5 prior lines of therapy in the advanced/metastatic disease setting). Participants must have archival or fresh tumor tissue available for submission at Screening.
- Arm 2: Participant life expectancy of ≥90 days.
- Arm 1 and Arm 2: Participant has an Eastern Cooperative Oncology Group performance status of ≤1.
- Arm 1 and Arm 2: Participant has adequate hematological and biological function.
- Arm 1 and Arm 2: Participants who could become pregnant: negative highly sensitive pregnancy test within 24 hours before the first dose of study treatment.
Who cannot join
- Arm 1 and Arm 2: Participant has active central nervous system tumors or metastases
- Arm 1 and Arm 2: Participant has received treatment with prohibited medications/treatments (that is, concurrent anticancer therapy including other chemotherapy, hormonal anticancer therapy, biologic therapy, or immunotherapy) or investigational agents within 5 half-lives or 14 days prior to the first day of study treatment (Cycle 1 Day 1), whichever is shorter.
- Arm 1 and Arm 2: Participant has required the use of immunosuppressive doses of systemic steroids or absorbed topical steroids (doses >10 milligrams [mg] prednisone daily equivalent) within 2 weeks before study treatment administration or currently requiring maintenance doses of >10 mg prednisone or equivalent per day.
- Arm 1 and Arm 2: Participant has any plan to receive a live attenuated vaccine during study treatment or has received a live vaccine within 30 days before the first dose of study treatment.
- Arm 1 and Arm 2: Participant has reversible toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline. Any unresolved toxicity National Cancer Institute Common Terminology Criteria for Adverse Events Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and prespecified laboratory values.
- Arm 1 and Arm 2: Participant has any unstable or clinically significant concurrent medical/psychiatric illness or social situation that would limit compliance with study requirements or compromise the ability of the participant to provide written informed consent, per the discretion of the Investigator.
- Arm 1 and Arm 2: Participant has concurrent enrollment in another clinical study (unless it is an observational noninterventional clinical study).
- Note: Other inclusion and exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
- Not yet recruiting
START Los Angeles
Los Angeles, California, 90025
- Recruiting
START San Antonio
San Antonio, Texas, 78229
- Recruiting
START Mountain Region
West Valley City, Utah, 84119
About this study
Official title: A Phase 1, Open-label, Multicenter, Dose-escalation Study of mRNA-4106 or mRNA-4200 Administered Alone or in Combination With Anti-Cancer Agents in Participants With Solid Tumors
The purpose of this study is to assess the safety and tolerability of mRNA-4106 monotherapy and of mRNA-4200 in combination with checkpoint inhibitor therapy in participants with solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- mRNA-4106, Pembrolizumab, mRNA-4200
- Keywords
- Locally advanced, Metastatic, Relapsed or refractory solid tumor malignancies, Pembrolizumab, Oncology, Melanoma, Solid tumors
- Medical subject headings
- Neoplasm Metastasis, Recurrence, Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-4106Biological
Intramuscular injection
PembrolizumabBiological
Intravenous infusion
mRNA-4200Biological
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Dose Escalation): mRNA-4106 Alone | Experimental | Participants will receive mRNA-4106 at a test dose as monotherapy. Receives: Biological: mRNA-4106 |
| Arm 2 (Dose Escalation): mRNA-4200 Alone and in Combination with Pembrolizumab | Experimental | Participants will receive mRNA-4200 as monotherapy, followed by mRNA-4200 in combination with pembrolizumab, and continuation of pembrolizumab alone. Receives: Biological: Pembrolizumab; Biological: mRNA-4200 |
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: For Arm 1: Days 1-21 and Arm 2: Days 1-42
Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Measured: Up to 2 years and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start25 Mar 2025
- Primary completion3 Aug 2027 (estimated)
- Study completion3 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880549
- Sponsor's protocol ID
- mRNA-4106-P101
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. 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-4106 or mRNA-4200 Administered Alone or in Combination With Anti-Cancer Agents in Participants With Solid Tumors
- ClinicalTrials.gov ID
- NCT06880549
- Acronym / sponsor ID
- mRNA-4106-P101
- Conditions
- Advanced Solid Tumors
- Keywords
- Locally advanced, Metastatic, Relapsed or refractory solid tumor malignancies, Pembrolizumab, Oncology, Melanoma, Solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 3 Aug 2027 (estimated)
- Study completion
- 3 Aug 2027 (estimated)
- First posted
- 17 Mar 2025 (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 purpose of this study is to assess the safety and tolerability of mRNA-4106 monotherapy and of mRNA-4200 in combination with checkpoint inhibitor therapy in participants with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Dose Escalation): mRNA-4106 Alone | Experimental | Biological: mRNA-4106Participants will receive mRNA-4106 at a test dose as monotherapy. |
| Arm 2 (Dose Escalation): mRNA-4200 Alone and in Combination with Pembrolizumab | Experimental | Biological: Pembrolizumab, Biological: mRNA-4200Participants will receive mRNA-4200 as monotherapy, followed by mRNA-4200 in combination with pembrolizumab, and continuation of pembrolizumab alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Arm 1: Histologically confirmed advanced or metastatic cancer (cutaneous melanoma, non-small cell lung cancer [NSCLC], hepatocellular carcinoma [HCC], esophageal carcinoma, head and neck squamous cell carcinoma [HNSCC], colon/rectal adenocarcinomas, urothelial/bladder, gastric, ovarian, cervical, and endometrial carcinomas) with measurable disease as determined by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1) and have completed or refused all standard therapies (no limit to prior lines of therapy). Participants must have a tumor lesion amenable to biopsy, or alternatively archival tumor tissue is acceptable as long as the collection date is within one year of the enrollment date.
- Arm 2: Histologically confirmed advanced or metastatic cancer (cutaneous melanoma, NSCLC, esophageal carcinoma, HNSCC, urothelial/bladder carcinoma, gastric, colon/rectal adenocarcinomas, ovarian, cervical, and endometrial carcinomas [Note: HCC not included]) with measurable disease as determined by RECIST v1.1 and have completed or refused all standard therapies (no more than 5 prior lines of therapy in the advanced/metastatic disease setting). Participants must have archival or fresh tumor tissue available for submission at Screening.
- Arm 2: Participant life expectancy of ≥90 days.
- Arm 1 and Arm 2: Participant has an Eastern Cooperative Oncology Group performance status of ≤1.
- Arm 1 and Arm 2: Participant has adequate hematological and biological function.
Key exclusion criteria (8 listed)
- Arm 1 and Arm 2: Participant has active central nervous system tumors or metastases
- Arm 1 and Arm 2: Participant has received treatment with prohibited medications/treatments (that is, concurrent anticancer therapy including other chemotherapy, hormonal anticancer therapy, biologic therapy, or immunotherapy) or investigational agents within 5 half-lives or 14 days prior to the first day of study treatment (Cycle 1 Day 1), whichever is shorter.
- Arm 1 and Arm 2: Participant has required the use of immunosuppressive doses of systemic steroids or absorbed topical steroids (doses >10 milligrams [mg] prednisone daily equivalent) within 2 weeks before study treatment administration or currently requiring maintenance doses of >10 mg prednisone or equivalent per day.
- Arm 1 and Arm 2: Participant has any plan to receive a live attenuated vaccine during study treatment or has received a live vaccine within 30 days before the first dose of study treatment.
- Arm 1 and Arm 2: Participant has reversible toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline. Any unresolved toxicity National Cancer Institute Common Terminology Criteria for Adverse Events Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and prespecified laboratory values.
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-4106Intramuscular injection | Biological | Arm 1 (Dose Escalation): mRNA-4106 Alone |
| PembrolizumabIntravenous infusion | Biological | Arm 2 (Dose Escalation): mRNA-4200 Alone and in Combination with Pembrolizumab |
| mRNA-4200Intramuscular injection | Biological | Arm 2 (Dose Escalation): mRNA-4200 Alone and in Combination with Pembrolizumab |
Primary outcome
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: For Arm 1: Days 1-21 and Arm 2: Days 1-42
Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Time frame: Up to 2 years and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mRNA-4106, Pembrolizumab and mRNA-4200 in people with Advanced Solid Tumors, run by ModernaTX, Inc. at 4 sites in United States.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moderna WeCare Team (1-866-663-3762, WeCareClinicalTrials@modernatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: For Arm 1: Days 1-21 and Arm 2: Days 1-42). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.