Clinical trial for Advanced Solid Tumors
Official title A 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
What this study is testing
What is mRNA-4106?
mRNA-4106 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Arm 1: Histologically confirmed advanced or metastatic cancer (melanoma, non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC)...
- Arm 2: Histologically confirmed advanced or metastatic cancer (melanoma, NSCLC, esophageal carcinoma, HNSCC, urothelial/bladder carcinoma, gastric...
- 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.
You likely can't join if
- 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...
- Arm 1 and Arm 2: Participant has required the use of immunosuppressive doses of systemic steroids or absorbed topical steroids (doses \>10 milligrams...
- 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...
- Arm 1 and Arm 2: Participant has reversible toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline. Any unresolved...
- Arm 1 and Arm 2: Participant has any unstable or clinically significant concurrent medical/psychiatric illness or social situation that would limit...
See the full eligibility criteria
- Arm 1: Histologically confirmed advanced or metastatic cancer (melanoma, non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), esophageal carcinoma, head and neck squamous cell carcinoma (HNSCC), urinary...
- Arm 2: Histologically confirmed advanced or metastatic cancer (melanoma, NSCLC, esophageal carcinoma, HNSCC, urothelial/bladder carcinoma, gastric, colon/rectal adenocarcinomas, ovarian, cervical, and endometrial...
- 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 pregnancy test within 24 hours before the first dose of study treatment. Key
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Grand Rapids, Michigan, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Grand Rapids, Michigan, United States; San Antonio, Texas, United States; West Valley City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.