Malignant TumorsPhase 1NCT07004244
Application of KRAS Vaccine in the Treatment of KRAS-mutated Malignancies
A Phase 1 study testing KRAS-mutated mRNA vaccine, TORIPALIMAB and Pemetrexed+carboplatin in people with Malignant Tumors, run by Sichuan University at 1 site in China.
Trial summary
The goal of this study is to evaluate the safety and efficacy of mRNA vaccine for the KRAS mutation malignant tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Tumors
- What is being tested?
- KRAS-mutated mRNA vaccine, TORIPALIMAB and Pemetrexed+carboplatin
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2025to 31 Dec 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
- Male or female participants ≥18 years of age.
- Participants with solid tumors confirmed to carry KRAS mutations.
- At least one measurable lesion according to RECIST 1.1 criteria.
- ECOG physical condition score: 0-1 point.
- Adequate organ and bone marrow function.
- Ability to understand and voluntarily provide written informed consent before trial participation.
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- Cohort-specific Inclusion Criteria:
- Cohort 1:
- Failure of prior standard therapy, intolerance to standard therapy, ineligibility for standard therapy, or absence of a standard treatment regimen.
- Life expectancy ≥3 months.
- Cohort 2:
- Newly diagnosed, treatment-naïve lung adenocarcinoma confirmed by pathology (histology/cytology).
- Resectable disease classified as stage IB-IIIA per AJCC 9th edition criteria.
- KRAS G12C/G12D/G12V/G13D mutation-positive by genomic testing.
Who cannot join
- Patients with a history of other malignancies.
- Presence of primary central nervous system (CNS) tumors, active CNS metastatic tumors, or carcinomatous meningitis, either historically or identified during screening.
- Uncontrolled moderate to massive serous cavity effusion.
- Confirmed presence of other classic gene variants.
- Known cardiac clinical symptoms or diseases that are poorly controlled.
- Unstable thrombotic events (e.g., deep vein thrombosis, arterial thrombosis, pulmonary embolism) requiring therapeutic intervention within 6 months prior to screening.
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- Any active autoimmune disease or a history of autoimmune disease.
- Uncontrolled clinical disorders, psychiatric illnesses, or other significant diseases as assessed by the investigator that may interfere with informed consent, compromise interpretation of trial results, pose risks to participants, or otherwise hinder the achievement of trial objectives.
- History of interstitial pneumonia or suspected interstitial pneumonia; or pulmonary abnormalities that may interfere with the detection or management of suspected drug-related pulmonary toxicity during the trial.
- Hypersensitivity to the investigational drug (including any excipients).
- Patients who received anti-tumor therapy within 4 weeks prior to the first dose, or those with unresolved adverse reactions (except alopecia) from prior anti-tumor therapy (NCI CTCAE > grade 1).
- Systemic use of corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressants within 14 days prior to the first dose.
- Participants who received drugs of the same class within 6 months prior to the first dose.
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis infection.
- Active tuberculosis (TB) or a history of active TB; or severe acute/chronic infections requiring systemic treatment.
- Pregnant or lactating women.
- Any other factors deemed by the investigator to render the participant unsuitable for trial participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Huashan Shi, Doctor, +86 18980606519, shijin825@163.com
About this study
Official title: Safety and Efficacy of KRAS Vaccine in the Treatment of KRAS-mutant Malignancies
The goal of this study is to evaluate the safety and efficacy of mRNA vaccine for the KRAS mutation malignant tumors.
Read the detailed description
The Kirsten rat sarcoma viral oncogene homolog (KRAS) is one of the most prevalent oncogenes in humans and plays a pivotal role in tumor initiation and progression. KRAS mutations are observed in various cancers, particularly in non-small cell lung cancer, colorectal cancer, and pancreatic cancer. Mutations in the KRAS gene activate multiple signaling pathways, such as MAPK/ERK and PI3K/AKT, which regulate cell proliferation, survival, and migration, thereby driving tumor progression and the development of drug resistance. Due to its critical role in cancer, KRAS has emerged as a key therapeutic target. However, the structural characteristics of KRAS mutants have historically rendered direct inhibition of the KRAS protein extremely challenging, leading to its designation as an "undruggable" target over the past decades. Consequently, patients with KRAS-mutated malignancies face limited treatment efficacy and a lack of precision therapeutic options. In recent years, advances in scientific technologies have enabled the successful development and marketing of several drugs targeting specific KRAS mutations. Nevertheless, most existing therapies exhibit suboptimal efficacy, necessitating further exploration of treatments for broader mutation types and larger cancer populations.
mRNA vaccines represent a highly promising novel approach in oncology. Preliminary reviews of global clinical trials investigating tumor-related mRNA therapeutics reveal that current research primarily focuses on malignancies such as melanoma, prostate cancer, colorectal cancer, acute myeloid leukemia, and breast cancer, with most studies in Phase I/II. Published data demonstrate that mRNA-based cancer therapies exhibit significant potential in anticancer immunotherapy and favorable safety profiles. Given the promising antitumor efficacy of mRNA therapeutic vaccines targeting KRAS mutations in KRAS-mutated tumors, coupled with the limited treatment options and poor outcomes for most KRAS-mutated cancer patients, monotherapy with mRNA therapeutic vaccines or their combination with immune checkpoint inhibitors may offer substantial clinical benefits. Accordingly, the research team plans to conduct an "Exploratory Study on the Application of mRNA Vaccines Targeting KRAS Mutations in KRAS-Mutated Malignancies."
- Conditions
- Malignant Tumors
- Being tested
- KRAS-mutated mRNA vaccine, TORIPALIMAB, Pemetrexed+carboplatin
- Keywords
- KRAS-mutated malignancies, mRNA vaccines, treatment, safety, efficacy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KRAS-mutated mRNA vaccineBiological
Cohort 1:From the initial dose, the dose was increased using a dose escalation scheme. Each subject only received one corresponding dose.
Cohort 2:KRAS-mutated mRNA vaccine+ Toripalimab + pemetrexed + carboplatin as neo-adjuvant treatment followed by surgery
TORIPALIMABBiological
intravenous injection
Pemetrexed+carboplatinDrug
intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | From the initial dose, the dose was increased using a dose escalation scheme. Each subject only received one corresponding dose. Receives: Biological: KRAS-mutated mRNA vaccine |
| Cohort 2 | Experimental | KRAS-mutated mRNA vaccine+ Toripalimab + pemetrexed + carboplatin as neo-adjuvant treatment followed by surgery Receives: Biological: KRAS-mutated mRNA vaccine; Biological: TORIPALIMAB; Drug: Pemetrexed+carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Adverse events defined as the number of participants with adverse events according to CTCAE v5.0.
Measured: up to 12 months
Immunogenicity of the mRNA vaccine
Measure vaccine-induced immune response (e.g., antigen-specific T-cell/B-cell responses or seroconversion rates).
Measured: up to 7 months
Secondary outcomes (5)
Objective response rate
ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)
Measured: up to 12 months
Progress-Free Survival
PFS is defined as the time from the administration of the first dose to first disease
Measured: up to 12 months
Overall Survival
OS is defined as the time from the administration of the first dose to death.
Measured: up to 12 months
Pathological response rates
Major pathological response (MPR, defined as ≤10% residual viable tumor); Pathological complete response (pCR)
Measured: up to 7 months
Surgical feasibility
R0 resection rate; Incidence of surgery delay or cancellation
Measured: up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start5 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital
- Responsible party
- Principal investigator, Zhen-Yu Ding, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004244
- Sponsor's protocol ID
- KRAS ST-2025
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang B, Peng X, Li J, Wang Y, Chen L, Wu M, Zhang Y, Wang W, Feng D, Tang S, Zhang L, Zhan X. Personalized mRNA vaccine combined with PD-1 inhibitor therapy in a patient with advanced esophageal squamous cell carcinoma. Am J Cancer Res. 2024 Aug 25;14(8):3896-3904. doi: 10.62347/NVFB3780. eCollection 2024.
PubMed 39267685Weber JS, Carlino MS, Khattak A, Meniawy T, Ansstas G, Taylor MH, Kim KB, McKean M, Long GV, Sullivan RJ, Faries M, Tran TT, Cowey CL, Pecora A, Shaheen M, Segar J, Medina T, Atkinson V, Gibney GT, Luke JJ, Thomas S, Buchbinder EI, Healy JA, Huang M, Morrissey M, Feldman I, Sehgal V, Robert-Tissot C, Hou P, Zhu L, Brown M, Aanur P, Meehan RS, Zaks T. Individualised neoantigen therapy mRNA-4157 (V940) plus pembrolizumab versus pembrolizumab monotherapy in resected melanoma (KEYNOTE-942): a randomised, phase 2b study. Lancet. 2024 Feb 17;403(10427):632-644. doi: 10.1016/S0140-6736(23)02268-7. Epub 2024 Jan 18.
PubMed 38246194Wang X, Wang W, Zou S, Xu Z, Cao D, Zhang S, Wei M, Zhan Q, Wen C, Li F, Chen H, Fu D, Jiang L, Zhao M, Shen B. Combination therapy of KRAS G12V mRNA vaccine and pembrolizumab: clinical benefit in patients with advanced solid tumors. Cell Res. 2024 Sep;34(9):661-664. doi: 10.1038/s41422-024-00990-9. Epub 2024 Jun 24. No abstract available.
PubMed 38914844Hou X, Zhang X, Zhao W, Zeng C, Deng B, McComb DW, Du S, Zhang C, Li W, Dong Y. Vitamin lipid nanoparticles enable adoptive macrophage transfer for the treatment of multidrug-resistant bacterial sepsis. Nat Nanotechnol. 2020 Jan;15(1):41-46. doi: 10.1038/s41565-019-0600-1. Epub 2020 Jan 6.
PubMed 31907443Miao L, Li L, Huang Y, Delcassian D, Chahal J, Han J, Shi Y, Sadtler K, Gao W, Lin J, Doloff JC, Langer R, Anderson DG. Delivery of mRNA vaccines with heterocyclic lipids increases anti-tumor efficacy by STING-mediated immune cell activation. Nat Biotechnol. 2019 Oct;37(10):1174-1185. doi: 10.1038/s41587-019-0247-3. Epub 2019 Sep 30.
PubMed 31570898Fenton OS, Kauffman KJ, McClellan RL, Kaczmarek JC, Zeng MD, Andresen JL, Rhym LH, Heartlein MW, DeRosa F, Anderson DG. Customizable Lipid Nanoparticle Materials for the Delivery of siRNAs and mRNAs. Angew Chem Int Ed Engl. 2018 Oct 8;57(41):13582-13586. doi: 10.1002/anie.201809056. Epub 2018 Sep 14.
PubMed 30112821Wang F, Qin Z, Lu H, He S, Luo J, Jin C, Song X. Clinical translation of gene medicine. J Gene Med. 2019 Jul;21(7):e3108. doi: 10.1002/jgm.3108. Epub 2019 Jul 15.
PubMed 31246328Reinhard K, Rengstl B, Oehm P, Michel K, Billmeier A, Hayduk N, Klein O, Kuna K, Ouchan Y, Woll S, Christ E, Weber D, Suchan M, Bukur T, Birtel M, Jahndel V, Mroz K, Hobohm K, Kranz L, Diken M, Kuhlcke K, Tureci O, Sahin U. An RNA vaccine drives expansion and efficacy of claudin-CAR-T cells against solid tumors. Science. 2020 Jan 24;367(6476):446-453. doi: 10.1126/science.aay5967. Epub 2020 Jan 2.
PubMed 31896660Nishikawa J, Yoshiyama H, Iizasa H, Kanehiro Y, Nakamura M, Nishimura J, Saito M, Okamoto T, Sakai K, Suehiro Y, Yamasaki T, Oga A, Yanai H, Sakaida I. Epstein-barr virus in gastric carcinoma. Cancers (Basel). 2014 Nov 7;6(4):2259-74. doi: 10.3390/cancers6042259.
PubMed 25386788Cox AD, Fesik SW, Kimmelman AC, Luo J, Der CJ. Drugging the undruggable RAS: Mission possible? Nat Rev Drug Discov. 2014 Nov;13(11):828-51. doi: 10.1038/nrd4389. Epub 2014 Oct 17.
PubMed 25323927Canon J, Rex K, Saiki AY, Mohr C, Cooke K, Bagal D, Gaida K, Holt T, Knutson CG, Koppada N, Lanman BA, Werner J, Rapaport AS, San Miguel T, Ortiz R, Osgood T, Sun JR, Zhu X, McCarter JD, Volak LP, Houk BE, Fakih MG, O'Neil BH, Price TJ, Falchook GS, Desai J, Kuo J, Govindan R, Hong DS, Ouyang W, Henary H, Arvedson T, Cee VJ, Lipford JR. The clinical KRAS(G12C) inhibitor AMG 510 drives anti-tumour immunity. Nature. 2019 Nov;575(7781):217-223. doi: 10.1038/s41586-019-1694-1. Epub 2019 Oct 30.
PubMed 31666701Witkiewicz AK, McMillan EA, Balaji U, Baek G, Lin WC, Mansour J, Mollaee M, Wagner KU, Koduru P, Yopp A, Choti MA, Yeo CJ, McCue P, White MA, Knudsen ES. Whole-exome sequencing of pancreatic cancer defines genetic diversity and therapeutic targets. Nat Commun. 2015 Apr 9;6:6744. doi: 10.1038/ncomms7744.
PubMed 25855536Simanshu DK, Nissley DV, McCormick F. RAS Proteins and Their Regulators in Human Disease. Cell. 2017 Jun 29;170(1):17-33. doi: 10.1016/j.cell.2017.06.009.
PubMed 28666118
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of KRAS Vaccine in the Treatment of KRAS-mutant Malignancies
- ClinicalTrials.gov ID
- NCT07004244
- Acronym / sponsor ID
- KRAS ST-2025
- Conditions
- Malignant Tumors
- Keywords
- KRAS-mutated malignancies, mRNA vaccines, treatment, safety, efficacy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Collaborators
- West China Hospital
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Jun 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 goal of this study is to evaluate the safety and efficacy of mRNA vaccine for the KRAS mutation malignant tumors.
Detailed description
The Kirsten rat sarcoma viral oncogene homolog (KRAS) is one of the most prevalent oncogenes in humans and plays a pivotal role in tumor initiation and progression. KRAS mutations are observed in various cancers, particularly in non-small cell lung cancer, colorectal cancer, and pancreatic cancer. Mutations in the KRAS gene activate multiple signaling pathways, such as MAPK/ERK and PI3K/AKT, which regulate cell proliferation, survival, and migration, thereby driving tumor progression and the development of drug resistance. Due to its critical role in cancer, KRAS has emerged as a key therapeutic target. However, the structural characteristics of KRAS mutants have historically rendered direct inhibition of the KRAS protein extremely challenging, leading to its designation as an "undruggable" target over the past decades. Consequently, patients with KRAS-mutated malignancies face limited treatment efficacy and a lack of precision therapeutic options. In recent years, advances in scientific technologies have enabled the successful development and marketing of several drugs targeting specific KRAS mutations. Nevertheless, most existing therapies exhibit suboptimal efficacy, necessitating further exploration of treatments for broader mutation types and larger cancer populations.
mRNA vaccines represent a highly promising novel approach in oncology. Preliminary reviews of global clinical trials investigating tumor-related mRNA therapeutics reveal that current research primarily focuses on malignancies such as melanoma, prostate cancer, colorectal cancer, acute myeloid leukemia, and breast cancer, with most studies in Phase I/II. Published data demonstrate that mRNA-based cancer therapies exhibit significant potential in anticancer immunotherapy and favorable safety profiles. Given the promising antitumor efficacy of mRNA therapeutic vaccines targeting KRAS mutations in KRAS-mutated tumors, coupled with the limited treatment options and poor outcomes for most KRAS-mutated cancer patients, monotherapy with mRNA therapeutic vaccines or their combination with immune checkpoint inhibitors may offer substantial clinical benefits. Accordingly, the research team plans to conduct an "Exploratory Study on the Application of mRNA Vaccines Targeting KRAS Mutations in KRAS-Mutated Malignancies."
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: KRAS-mutated mRNA vaccineFrom the initial dose, the dose was increased using a dose escalation scheme. Each subject only received one corresponding dose. |
| Cohort 2 | Experimental | Biological: KRAS-mutated mRNA vaccine, Biological: TORIPALIMAB, Drug: Pemetrexed+carboplatinKRAS-mutated mRNA vaccine+ Toripalimab + pemetrexed + carboplatin as neo-adjuvant treatment followed by surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female participants ≥18 years of age.
- Participants with solid tumors confirmed to carry KRAS mutations.
- At least one measurable lesion according to RECIST 1.1 criteria.
- ECOG physical condition score: 0-1 point.
- Adequate organ and bone marrow function.
Key exclusion criteria (18 listed)
- Patients with a history of other malignancies.
- Presence of primary central nervous system (CNS) tumors, active CNS metastatic tumors, or carcinomatous meningitis, either historically or identified during screening.
- Uncontrolled moderate to massive serous cavity effusion.
- Confirmed presence of other classic gene variants.
- Known cardiac clinical symptoms or diseases that are poorly controlled.
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 |
|---|---|---|
| KRAS-mutated mRNA vaccineCohort 1:From the initial dose, the dose was increased using a dose escalation scheme. Each subject only received one corresponding dose. Cohort 2:KRAS-mutated mRNA vaccine+ Toripalimab + pemetrexed + carboplatin as neo-adjuvant treatment followed by surgery | Biological | Cohort 1, Cohort 2 |
| TORIPALIMABintravenous injection | Biological | Cohort 2 |
| Pemetrexed+carboplatinintravenous injection | Drug | Cohort 2 |
Primary outcome
Adverse events
Time frame: up to 12 months
Adverse events defined as the number of participants with adverse events according to CTCAE v5.0.
Immunogenicity of the mRNA vaccine
Time frame: up to 7 months
Measure vaccine-induced immune response (e.g., antigen-specific T-cell/B-cell responses or seroconversion rates).
5 secondary outcomes
Objective response rate
Time frame: up to 12 months
Progress-Free Survival
Time frame: up to 12 months
Overall Survival
Time frame: up to 12 months
Pathological response rates
Time frame: up to 7 months
Surgical feasibility
Time frame: up to 7 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 24 Jun 2025.
- Background: PubMed 39267685Wang B, Peng X, Li J, Wang Y, Chen L, Wu M, Zhang Y, Wang W, Feng D, Tang S, Zhang L, Zhan X. Personalized mRNA vaccine combined with PD-1 inhibitor therapy in a patient with advanced esophageal squamous cell carcinoma. Am J Cancer Res. 2024 Aug 25;14(8):3896-3904. doi: 10.62347/NVFB3780. eCollection 2024.
- Background: PubMed 38246194Weber JS, Carlino MS, Khattak A, Meniawy T, Ansstas G, Taylor MH, Kim KB, McKean M, Long GV, Sullivan RJ, Faries M, Tran TT, Cowey CL, Pecora A, Shaheen M, Segar J, Medina T, Atkinson V, Gibney GT, Luke JJ, Thomas S, Buchbinder EI, Healy JA, Huang M, Morrissey M, Feldman I, Sehgal V, Robert-Tissot C, Hou P, Zhu L, Brown M, Aanur P, Meehan RS, Zaks T. Individualised neoantigen therapy mRNA-4157 (V940) plus pembrolizumab versus pembrolizumab monotherapy in resected melanoma (KEYNOTE-942): a randomised, phase 2b study. Lancet. 2024 Feb 17;403(10427):632-644. doi: 10.1016/S0140-6736(23)02268-7. Epub 2024 Jan 18.
- Background: PubMed 38914844Wang X, Wang W, Zou S, Xu Z, Cao D, Zhang S, Wei M, Zhan Q, Wen C, Li F, Chen H, Fu D, Jiang L, Zhao M, Shen B. Combination therapy of KRAS G12V mRNA vaccine and pembrolizumab: clinical benefit in patients with advanced solid tumors. Cell Res. 2024 Sep;34(9):661-664. doi: 10.1038/s41422-024-00990-9. Epub 2024 Jun 24. No abstract available.
- Background: PubMed 31907443Hou X, Zhang X, Zhao W, Zeng C, Deng B, McComb DW, Du S, Zhang C, Li W, Dong Y. Vitamin lipid nanoparticles enable adoptive macrophage transfer for the treatment of multidrug-resistant bacterial sepsis. Nat Nanotechnol. 2020 Jan;15(1):41-46. doi: 10.1038/s41565-019-0600-1. Epub 2020 Jan 6.
- Background: PubMed 31570898Miao L, Li L, Huang Y, Delcassian D, Chahal J, Han J, Shi Y, Sadtler K, Gao W, Lin J, Doloff JC, Langer R, Anderson DG. Delivery of mRNA vaccines with heterocyclic lipids increases anti-tumor efficacy by STING-mediated immune cell activation. Nat Biotechnol. 2019 Oct;37(10):1174-1185. doi: 10.1038/s41587-019-0247-3. Epub 2019 Sep 30.
- Background: PubMed 30112821Fenton OS, Kauffman KJ, McClellan RL, Kaczmarek JC, Zeng MD, Andresen JL, Rhym LH, Heartlein MW, DeRosa F, Anderson DG. Customizable Lipid Nanoparticle Materials for the Delivery of siRNAs and mRNAs. Angew Chem Int Ed Engl. 2018 Oct 8;57(41):13582-13586. doi: 10.1002/anie.201809056. Epub 2018 Sep 14.
- Background: PubMed 31246328Wang F, Qin Z, Lu H, He S, Luo J, Jin C, Song X. Clinical translation of gene medicine. J Gene Med. 2019 Jul;21(7):e3108. doi: 10.1002/jgm.3108. Epub 2019 Jul 15.
- Background: PubMed 31896660Reinhard K, Rengstl B, Oehm P, Michel K, Billmeier A, Hayduk N, Klein O, Kuna K, Ouchan Y, Woll S, Christ E, Weber D, Suchan M, Bukur T, Birtel M, Jahndel V, Mroz K, Hobohm K, Kranz L, Diken M, Kuhlcke K, Tureci O, Sahin U. An RNA vaccine drives expansion and efficacy of claudin-CAR-T cells against solid tumors. Science. 2020 Jan 24;367(6476):446-453. doi: 10.1126/science.aay5967. Epub 2020 Jan 2.
- Background: PubMed 25386788Nishikawa J, Yoshiyama H, Iizasa H, Kanehiro Y, Nakamura M, Nishimura J, Saito M, Okamoto T, Sakai K, Suehiro Y, Yamasaki T, Oga A, Yanai H, Sakaida I. Epstein-barr virus in gastric carcinoma. Cancers (Basel). 2014 Nov 7;6(4):2259-74. doi: 10.3390/cancers6042259.
- Background: PubMed 25323927Cox AD, Fesik SW, Kimmelman AC, Luo J, Der CJ. Drugging the undruggable RAS: Mission possible? Nat Rev Drug Discov. 2014 Nov;13(11):828-51. doi: 10.1038/nrd4389. Epub 2014 Oct 17.
- Background: PubMed 31666701Canon J, Rex K, Saiki AY, Mohr C, Cooke K, Bagal D, Gaida K, Holt T, Knutson CG, Koppada N, Lanman BA, Werner J, Rapaport AS, San Miguel T, Ortiz R, Osgood T, Sun JR, Zhu X, McCarter JD, Volak LP, Houk BE, Fakih MG, O'Neil BH, Price TJ, Falchook GS, Desai J, Kuo J, Govindan R, Hong DS, Ouyang W, Henary H, Arvedson T, Cee VJ, Lipford JR. The clinical KRAS(G12C) inhibitor AMG 510 drives anti-tumour immunity. Nature. 2019 Nov;575(7781):217-223. doi: 10.1038/s41586-019-1694-1. Epub 2019 Oct 30.
- Background: PubMed 25855536Witkiewicz AK, McMillan EA, Balaji U, Baek G, Lin WC, Mansour J, Mollaee M, Wagner KU, Koduru P, Yopp A, Choti MA, Yeo CJ, McCue P, White MA, Knudsen ES. Whole-exome sequencing of pancreatic cancer defines genetic diversity and therapeutic targets. Nat Commun. 2015 Apr 9;6:6744. doi: 10.1038/ncomms7744.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KRAS-mutated mRNA vaccine, TORIPALIMAB and Pemetrexed+carboplatin in people with Malignant Tumors, run by Sichuan University at 1 site in China.
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 14 inclusion and 18 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 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: up to 12 months). 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?
On the ClinicalTrials.gov record for NCT07004244, which also lists 13 linked publications.
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 24 Jun 2025.