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Advanced Malignant Solid TumorPhase 1NCT03662815

Clinical Study of a Personalized Neoantigen Cancer Vaccine in Treating Patients With Advanced Malignant Tumor

A Phase 1 study testing iNeo-Vac-P01 and GM-CSF in people with Advanced Malignant Solid Tumor, run by Sir Run Run Shaw Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This research study is evaluating a new type of cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for advanced malignant tumor. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Malignant Solid Tumor
What is being tested?
iNeo-Vac-P01 and GM-CSF
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
7 Feb 2018to 30 Dec 2022
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must freely sign informed consent;
  • Aged 18 to 75 years old;
  • The expected survival period is more than 6 months;
  • ECOG score is 0 or 1;
  • Patients with advanced tumors who fail to receive standard therapy, and those who are not suitable or refuse standard adjuvant therapy;
  • Advanced malignant cancer diagnosed by pathology and imageology;
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  • At least one measurable lesions;
  • To be able to obtain sufficient tumor tissue samples and blood samples for analysis, or to have genomic/exon/transcriptional data of tumor tissues and normal tissues, and the data meet the analysis requirements;
  • The main organs function is normal, such as the heart, liver and kidney;
  • Haematological index:
  • neutrophil count≥1.5×109/L
  • hemoglobin≥10g/dL
  • platelet count≥100×109/L
  • Biochemical index:
  • Total bilirubin is less than or equal to 1.5 times the upper limit of normal value (ULN)
  • AST and ALT is less than or equal to 2.5 times the upper limit of normal value
  • Serum creatinine and urea nitrogen (BUN) is less than or equal to 1.5 times the upper limit of normal value
  • Pregnant, lactating women and women of child-bearing age must have a negative pregnancy test within 7 days before entering the group, and short-term have no fertility plan, and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial;
  • Good compliance, able to follow research protocols and follow-up procedures.

Who cannot join

  • Diagnosed as other malignant tumor, but cured basal cell carcinoma, thyroid carcinoma, cervical dysplasia etc is excluded;
  • No neoantigen was found in the sequencing data;
  • There have been bone marrow or stem cell transplants;
  • Systemic cancer treatment or other drugs under study were treated within 4 weeks prior to individualized tumor targeted polypeptides treatment;
  • Received other polypeptide inoculation 4 weeks before treatment; Patients may not be vaccinated with other polypeptides 8 weeks after the last individualized tumor targeted polypeptides trentment;
  • Active bacterial or fungal infections identified clinically (>= level 2 of NCI-CTC edition 3);
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  • Patients with HIV, HCV, HBV infection, severe asthma, autoimmune disease, immunodeficiency or treated with immunosuppressive drugs;
  • People infected with herpes virus (scabbed for more than 4 weeks is excluded);
  • People infected with respiratory virus (cured for more than 4 weeks is excluded);
  • Severe coronary or cerebrovascular disease, or other diseases that the investigators considered should to be exclusion;
  • Drug abuse, Clinical, psychological or social factor result in affecting informed consent or research implementation;
  • Have a history of drug or polypeptide allergies, or people who are allergic to other potential immunotherapies.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310000

Other trials in China

About this study

Official title: Safety, Tolerability and Partial Efficacy Study of a Personalized Neoantigen Cancer Vaccine inTreating Patients With Advanced Malignant Tumor

This research study is evaluating a new type of cancer vaccine called "Personalized Neoantigen Cancer Vaccine" as a possible treatment for advanced malignant tumor. The purpose of the clinical study is evaluating the safety, tolerability and partial efficacy of the personalized neoantigen cancer vaccine in the treatment of Chinese patients with advanced malignant cancer, so as to provide a new personalized therapeutic strategy for advanced pancreatic cancer patients.

It is known that cancer patients have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the cancer to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.

Being tested
iNeo-Vac-P01, GM-CSF
Keywords
Neoantigen, iNeo-Vac-P01, Peptide Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iNeo-Vac-P01Biological

    Neoantigen peptides

  • GM-CSFOther

    Also called granulocyte-macrophage colony stimulating factor

    immune adjuvant

Study groups in NCT03662815
Study groupRoleWhat they receive
iNeo-Vac-P01ExperimentalPersonal Cancer Vaccine: iNeo-Vac-P01 (peptides)+ GM-CSF; Peptides: 0.1 or 0.3 mg per peptide given on days 1, 4, 8, 15, 22, 78, and 162 for a total of 7 doses. Additional booster vaccines might be administered depending on ethics and patients' potential benefit. GM-CSF: 40 mcg given 30 minutes before iNeo-Vac-P01.
Receives: Biological: iNeo-Vac-P01; Other: GM-CSF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    Measured: 2 years

  2. Number of participants experiencing clinical and laboratory adverse events (AEs)

    Measured: 1 year

Secondary outcomes (2)

  1. Overall Survival Rate

    Measured: 2 years

  2. Progression Free Survival

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2018
  2. Study start7 Feb 2018
  3. Primary completion20 May 2021
  4. Study completion30 Dec 2022 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03662815
Sponsor's protocol ID
INEO-P-002
Status last verified
Nov 2021
First submitted
5 Sep 2018
Last updated
16 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Weden S, Klemp M, Gladhaug IP, Moller M, Eriksen JA, Gaudernack G, Buanes T. Long-term follow-up of patients with resected pancreatic cancer following vaccination against mutant K-ras. Int J Cancer. 2011 Mar 1;128(5):1120-8. doi: 10.1002/ijc.25449.

    PubMed 20473937

  • Ott PA, Hu Z, Keskin DB, Shukla SA, Sun J, Bozym DJ, Zhang W, Luoma A, Giobbie-Hurder A, Peter L, Chen C, Olive O, Carter TA, Li S, Lieb DJ, Eisenhaure T, Gjini E, Stevens J, Lane WJ, Javeri I, Nellaiappan K, Salazar AM, Daley H, Seaman M, Buchbinder EI, Yoon CH, Harden M, Lennon N, Gabriel S, Rodig SJ, Barouch DH, Aster JC, Getz G, Wucherpfennig K, Neuberg D, Ritz J, Lander ES, Fritsch EF, Hacohen N, Wu CJ. An immunogenic personal neoantigen vaccine for patients with melanoma. Nature. 2017 Jul 13;547(7662):217-221. doi: 10.1038/nature22991. Epub 2017 Jul 5.

    PubMed 28678778

  • Shou J, Mo F, Zhang S, Lu L, Han N, Liu L, Qiu M, Li H, Han W, Ma D, Guo X, Guo Q, Huang Q, Zhang X, Ye S, Pan H, Chen S, Fang Y. Combination treatment of radiofrequency ablation and peptide neoantigen vaccination: Promising modality for future cancer immunotherapy. Front Immunol. 2022 Sep 29;13:1000681. doi: 10.3389/fimmu.2022.1000681. eCollection 2022.

    PubMed 36248865

  • Fang Y, Mo F, Shou J, Wang H, Luo K, Zhang S, Han N, Li H, Ye S, Zhou Z, Chen R, Chen L, Liu L, Wang H, Pan H, Chen S. A Pan-cancer Clinical Study of Personalized Neoantigen Vaccine Monotherapy in Treating Patients with Various Types of Advanced Solid Tumors. Clin Cancer Res. 2020 Sep 1;26(17):4511-4520. doi: 10.1158/1078-0432.CCR-19-2881. Epub 2020 May 21.

    PubMed 32439700

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing iNeo-Vac-P01 and GM-CSF in people with Advanced Malignant Solid Tumor, run by Sir Run Run Shaw Hospital 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 19 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 16 Nov 2021. 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?

Results are not available in the source record.

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?

Objective Response Rate (time frame: 2 years). 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 NCT03662815, which also lists 4 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 16 Nov 2021.

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