Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors (KEYNOTE-603)

JRCT ID: jRCT2033240236

Registered date:24/07/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Solid tumors
• Date of first enrollment: 24/07/2024
• Target sample size: 30
• Countries of recruitment: Australia,Japan,England,Japan,U.S.A.,Japan
• Study type: Interventional

Intervention(s)

Participants will receive mRNA-4157 via an intramuscular (IM) injection on Day 1 of each 21-day cycle for up to 9 cycles.
mRNA-4157: IM injection
Pembrolizumab: Intravenous infusion

Outcome(s)

• Primary Outcome: Safety and tolerability

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Part E1, E2: Participants with untreated histologically/cytologically confirmed Stage II-IIIB NSCLC (per AJCC v8) that is considered resectable of non-squamous (adenocarcinoma only) or squamous cell carcinoma histology. Absence of major associated pathologies that increase the surgery risk to an unacceptable level. Must have a tumor tissue sample available for NGS and PD-L1 IHC testing as defined in the Laboratory Manual.
- Part E3: Participants with untreated, locally advanced surgically resectable, histologically/cytologically confirmed, gastric/GEJ adenocarcinoma, as defined by a primary lesion that is T3 or greater or with the presence of any positive clinical nodes (N+) and without evidence of metastatic disease. Measurable disease according to RECIST version 1.1. Absence of major associated pathologies that increase the surgery risk to an unacceptable level. Must have a tumor tissue sample available for NGS and PD-L1 IHC testing as defined in the Laboratory Manual.

Exclude criteria

- Treatment with any of the following:
1. Any investigational agents or study drugs from a previous clinical study within 4 weeks of the first dose of mRNA-4157 or pembrolizumab (note only a 2 week wash out is required from prior pembrolizumab treatment).
2. Any chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks of the first dose of mRNA-4157 or pembrolizumab.
3. Live-virus vaccination within 30 days of the first dose of mRNA-4157 or pembrolizumab. Seasonal flu vaccines that do not contain live virus are permitted.
4. Any systemic steroid therapy or other form of immunosuppressive therapy within 7 days of the first dose of mRNA-4157 or pembrolizumab.
5. Transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including G-CSF, GM-CSF or recombinant erythropoietin) within 1 week of the screening blood sample (including the NGS blood sample), and within 4 weeks of the first dose of mRNA-4157 and/or pembrolizumab.
- A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Previously identified hypersensitivity to components of the formulations used in this study.
- Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone curative therapy or in situ cervical cancer.

Related Information

• Primary Sponsor: Watabe Mitsuo
• Secondary ID(s): NCT03313778,2023-505192-77-00