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Solid Tumor, AdultPhase 2NCT05986981

MUC1 Therapeutic Tumor Vaccine in Advanced Solid Cancers

A Phase 2 study testing Vaccine in people with Solid Tumor, Adult, run by Peking Union Medical College 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 The sponsor has not verified this record for over two years, so it may be out of date.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 is an investigator-initiated, single-center, open, single-arm, exploratory study of a therapeutic cancer vaccine for the treatment of advanced solid tumors. A dose-escalation trial is being conducted in subjects diagnosed with advanced solid tumors to evaluate the safety and tolerability of the cancer vaccine in… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor, Adult
What is being tested?
Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
Aug 2023to Dec 2024
Phase
Phase 2
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

  • screening period patients are able to understand and voluntarily sign an informed consent form;
  • males and females between the ages of 18 and 75 years (both ends included);
  • expected survival ≥ 3 months;
  • advanced subjects with histologically or cytologically proven advanced solid tumors who have failed standard multiline therapy;
  • have at least one measurable lesion (i.e., mass ≥10 mm in diameter and malignant lymph node ≥15 mm in short diameter on enhanced scan with layer thickness ≤5 mm on spiral CT) according to the efficacy evaluation criteria for solid tumors, RECIST version 1.1 (see Appendix 4, Criteria for Evaluating the Efficacy of Solid Tumor Treatments);
  • Fresh or archived tumor tissue samples within 5 years are available for central laboratory testing during the screening period (if they are truly unavailable, this will not affect enrollment);
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  • ECOG physical status score of 0 to 2;
  • treatment with other anti-tumor drugs (e.g., chemotherapy, hormone therapy, immunotherapy, antibody therapy, radiotherapy) prior to the first dose exceeds the 5 half-life of the drug or more than 4 weeks before the first dose (whichever is shorter);
  • Organ function levels must meet the following requirements (no blood or blood product transfusion, hematopoietic stimulating factor, albumin, or blood product use within 14 days prior to the examination): absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 75 × 109/L, hemoglobin (Hb) ≥ 90 g/L; serum total bilirubin (TBIL) ≤ 1.5 Total bilirubin (TBIL) ≤1.5 times the upper limit of normal value, glutamic transaminase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal value (if liver metastasis is present, total bilirubin ≤3 times the upper limit of normal value, AST and ALT ≤5 times the upper limit of normal value are allowed). 10;
  • Pre-menopausal women of childbearing potential must undergo a pregnancy test within 7 days prior to the start of treatment, and the result of the pregnancy test must be negative and non-lactating; women without childbearing potential may not undergo a pregnancy test and contraception, provided they are over 50 years of age, have not used hormone therapy and have stopped menstruating for at least 12 months, or have been sterilized. All enrolled subjects (either male or female) should use adequate barrier contraception throughout the treatment period and for 3 months after completion of treatment.
  • Other toxicity parameters must be NCI-CTCAE v.5.0 Grade 0 or 1.

Who cannot join

  • Subjects who require long-term systemic application of anti-allergic medications or who have a history of life-threatening allergic reactions to any vaccine or medication;
  • those with symptomatic or rapidly progressing central system metastases. Presence of extensive pulmonary metastases causing respiratory distress; subjects with tumours in close proximity to or invading large blood vessels or nerves;
  • new cerebrovascular accidents (including ischaemic stroke, haemorrhagic stroke and transient ischaemic attack) within 6 months prior to screening;
  • acute myocardial infarction, uncontrolled angina pectoris, uncontrolled arrhythmia, severe heart failure (see Appendix 3, New York Heart Association's Heart Failure Classification Criteria, NYHA Class ≥ III) and other cardiovascular diseases within 6 months prior to screening;
  • have received immunomodulatory medications within 4 weeks prior to the date of first vaccination (D1), including, but not limited to, IL-2, CTLA-4 inhibitors, CD40 agonists, CD137 agonists, and IFN-alpha (except for high-risk surgical subjects using IFN-alpha as an adjuvant therapy if IFN-alpha therapy was discontinued within the 4 weeks prior to the date of the trial);
  • those with a history of renal insufficiency with serum creatinine levels greater than 1.5 times the upper limit of normal;
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  • have received a blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 2 weeks prior to the first dose of drug;
  • subjects with skin conditions that may prevent intradermal vaccine from reaching the target area (e.g., psoriasis);
  • subjects in the Screening Period who continue to have adverse reactions from prior anti-neoplastic therapy that have not been restored to a CTCAE Version 5.0 grade rating of ≤ Grade 1 (with the exception of alopecia and platinum-induced neurotoxicity of ≤ Grade 2);
  • need for concomitant use of steroidal hormonal medications (tumour or non-tumour related disease); exceptions may be made for those requiring topical (not applied to the vaccination site) or inhaled steroids;
  • the presence of active or uncontrollable infections requiring systemic therapy (except for simple urinary tract infections or upper respiratory tract infections) in the subject within 4 weeks prior to screening; and the presence of antibodies to the Human Immunodeficiency Virus (HIV), hepatitis B Surface Antigen (SAB) positive and/or hepatitis B Core Antibody (HBCO) positive with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) >1000 copies/mL and Hepatitis C virus (HCV) antibodies on virological testing during the Screening Period, Subjects who are positive for antibodies specific to syphilis spirochetes;
  • poorly controlled hypertension (defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) after treatment;
  • subjects with a history of autoimmune disease [e.g., the following, but not limited to: interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (hypothyroidism without clinical symptoms or hypothyroidism due to radiotherapy may be included), subjects with vitiligo or cured asthma that does not currently require any intervention may be included, subjects requiring bronchodilators for medical intervention cannot be included];
  • subjects with active ulcers or gastrointestinal bleeding during the Screening Period;
  • subjects who have received a previous similar therapeutic cancer vaccine or who have received another vaccine within 4 weeks prior to Screening;
  • subjects with congenital or acquired immunodeficiency;
  • subjects who have participated in other clinical trials within 1 month prior to screening;
  • subjects with known alcohol or drug addiction;
  • subjects who, in the opinion of the investigator, have an underlying health condition, mental condition, or social condition that makes the subject unable or unwilling to comply with the study protocol
  • any other condition which, in the opinion of the Investigator, makes participation in this study inappropriate.

Trial locations and contacts

1 site in 1 country.

Fang Li, MD contact

+86-010-69154417

lifang@pumch.cn

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Fang Li, MD, +86-010-69154417, lifang@pumch.cn

Other trials in China

About this study

Official title: Single-arm, Open-label Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of MUC1 Therapeutic Tumor Vaccine in Advanced Solid Cancers

This is an investigator-initiated, single-center, open, single-arm, exploratory study of a therapeutic cancer vaccine for the treatment of advanced solid tumors. A dose-escalation trial is being conducted in subjects diagnosed with advanced solid tumors to evaluate the safety and tolerability of the cancer vaccine in subjects with advanced solid tumors and to preliminarily evaluate the efficacy of the tumor vaccine in subjects with advanced solid tumors.

Read the detailed description

Malignant tumours have become one of the major public health problems that seriously threaten human health. According to the latest global cancer burden data for 2020 released by the International Agency for Research on Cancer (IARC) of the World Health Organization (WHO), there will be 19.29 million new cancer cases and 9.96 million deaths globally in 2020; in 2020, there will be 4.57 million new cancer cases and 3 million deaths in China, with the number of new cancers in China accounting for 23.7% of the global incidence and 30% of the global deaths, both of which are the highest in the world. The number of new cancer cases in China accounts for 23.7% of global incidence and the number of cancer deaths accounts for 30% of global deaths, both of which rank first in the world, with lung, liver, stomach, esophagus and colorectal cancers having the highest mortality rates.

At present, in addition to the traditional surgery, radiotherapy and chemotherapy treatments for malignant tumours, with the advancement of biological sciences, tumour immunotherapy has developed significantly, in which antibody drugs and cell therapy (chimeric antigen receptor T cell, CAR-T) have products on the market. With the deepening research on the characteristics of tumour cells and the differences in protein expression, therapeutic cancer vaccines have gradually moved from theory to practice and have shown good performance in clinical trials.

The therapeutic cancer vaccine YB-01 is a therapeutic cancer vaccine formulation developed by the Department of Nuclear Medicine of Peking Union Medical College Hospital and commissioned to be produced by Zhaoyan Biologicals, a company with the qualification of Good manufacturing practice (GMP), and developed by Yuanben (Zhuhai Hengqin) Biotech Co. YB-01 cancer vaccine is a recombinant fusion protein with aluminium adjuvant and CpG182 adjuvant, and its core component is Mucin N-terminal region (MNR), which is specifically expressed by cancer cells. Mucin1 (MUC1) is a glycoprotein that plays a pivotal role in tumour formation, growth, invasion, signalling, pro-angiogenesis, anoxia and chemoresistance. Normal epithelial cells exist with low expression of MUC1, whereas cancerous cells have high expression of MUC1 (100-fold increase), and this differential expression is due to the fact that it is abnormally pronounced in biliary pancreatic carcinoma, cholangiocarcinoma, gastric adenocarcinoma, breast carcinoma and neuroendocrine pancreatic carcinoma, so that vaccine-induced immune response is only directed against the cancerous cells, but not against the normal tissues, and non-glycosylated MUC1 has become an important target for cancer therapy.YB- 01 vaccine targets MUC1 and enhances humoral and cell-mediated immune responses through immunity to MUC1 peptide or MUC1 peptide-activated dendritic cells (DC).DC cells activate CD4 T cells, which promotes the activation of B cells to produce antibodies against MUC1, and DC cells also activate CD8 T cells, which target and kill tumour cells that express MUC1. cells expressing MUC1.

Approximately 9-18 subjects will be recruited in this study. The investigational drug used in the study is the therapeutic cancer vaccine YB-01, and the study is designed to investigate the safety, tolerability, and preliminary efficacy of the vaccine in subjects with advanced solid tumours.

Being tested
Vaccine
Keywords
vaccine, Mucin 1, MUC1, malignant tumor
Medical subject headings
Medullary cystic kidney disease 1, Neoplasms

What participants receive

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

  • VaccineDrug

    Dose-escalation trial, according to the classic "3+3" model, divided into three dose levels of 0.5 mg, 1.0 mg, 2.0 mg for enrollment, is expected to enroll a total of 9-18 subjects (0.5 mg dose group to be enrolled in 3-6 subjects, 1.0 mg dose group is proposed to be enrolled in 3-6 subjects, 2.0 mg dose group is proposed to be enrolled in 3-6 subjects, and the dose group is proposed to be enrolled in 3-6 subjects, and the dose group is proposed to be enrolled in 3-6 subjects. dose group is proposed to include 3-6 subjects).

Study groups in NCT05986981
Study groupRoleWhat they receive
MUC1 VaccineExperimentalEnrollment by cohort from the starting dose of the trial and proceed to the next higher dose level if no one of the first 3 subjects develops DLT. If 1 of the 3 subjects develops DLT, then 3 additional subjects will be added to that dose level for a total of 6 subjects. If only 1 of 6 subjects develops DLT, proceed to the next higher dose level. If no fewer than 2 of the 6 subjects develop DLT, no more subjects will be added to that dose level and dose escalation will cease. The Safety Monitoring Committee (SMC) decides whether to use the intermediate dose as the next dose level for the study. Until the maximum sample size specified in the protocol or the SMC decides to terminate the dose increment.each subject receives only one dose group of study drug (during the incremental period, subjects may receive a reduced dose to continue treatment after the investigator has assessed the risk-benefit for safety reasons; dose increments are not permitted for the same subject).
Receives: Drug: Vaccine

What is being measured

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

  1. The safety of the vaccine using CTCAE v5.0 based on the number of patients with treatment-related adverse events.

    Assess the safety of the vaccine using CTCAE v5.0 based on the number of patients with treatment-related adverse events.

    Measured: 8~12weeks

  2. DLT

    Inject 0.5 to 2.0 mg of vaccine intramuscularly over a 16-week cycle to determine dose-limiting toxicity (DLT).

    Measured: 8~12weeks

  3. RP2D

    Determine if the maximum tolerated dose is among the doses explored and determine the recommended phase 2 dose (RP2D) of the vaccine.

    Measured: 8~12weeks

Secondary outcomes (1)

  1. Preliminary assessment of the effectiveness of therapeutic oncology vaccines in advanced solid tumors.

    Preliminary assessment of the effectiveness of therapeutic oncology vaccines in advanced solid tumors.

    Measured: 2years

Timeline

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

  1. First posted14 Aug 2023
  2. Study startAug 2023 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2024 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study flow included a screening period (week -4 to day -1), a treatment period (day 1 to week 8 or 16, including a DLT observation period on days 1-28), an end-of-treatment visit, and a survival follow-up. The treatment period included the initial treatment period (day 1 to week 8) and the augmentation period (week 12 to week 16). Subjects after signing and providing formal informed consent entered the screening period, during which eight separate administrations of the vaccine were administered, of which the investigator determined whether to continue treatment from week 8 to week 12 based on a combination of efficacy, safety, and adherence.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05986981
Sponsor's protocol ID
PekingUMCHVaccineMUC1
Status last verified
Aug 2023
First submitted
4 May 2023
Last updated
14 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arnold M, Morgan E, Rumgay H, Mafra A, Singh D, Laversanne M, Vignat J, Gralow JR, Cardoso F, Siesling S, Soerjomataram I. Current and future burden of breast cancer: Global statistics for 2020 and 2040. Breast. 2022 Dec;66:15-23. doi: 10.1016/j.breast.2022.08.010. Epub 2022 Sep 2.

    PubMed 36084384

  • Rumgay H, Shield K, Charvat H, Ferrari P, Sornpaisarn B, Obot I, Islami F, Lemmens VEPP, Rehm J, Soerjomataram I. Global burden of cancer in 2020 attributable to alcohol consumption: a population-based study. Lancet Oncol. 2021 Aug;22(8):1071-1080. doi: 10.1016/S1470-2045(21)00279-5.

    PubMed 34270924

  • O'Donnell JS, Teng MWL, Smyth MJ. Cancer immunoediting and resistance to T cell-based immunotherapy. Nat Rev Clin Oncol. 2019 Mar;16(3):151-167. doi: 10.1038/s41571-018-0142-8.

    PubMed 30523282

  • Lei K, Kurum A, Kaynak M, Bonati L, Han Y, Cencen V, Gao M, Xie YQ, Guo Y, Hannebelle MTM, Wu Y, Zhou G, Guo M, Fantner GE, Sakar MS, Tang L. Cancer-cell stiffening via cholesterol depletion enhances adoptive T-cell immunotherapy. Nat Biomed Eng. 2021 Dec;5(12):1411-1425. doi: 10.1038/s41551-021-00826-6. Epub 2021 Dec 6.

    PubMed 34873307

  • Riley RS, June CH, Langer R, Mitchell MJ. Delivery technologies for cancer immunotherapy. Nat Rev Drug Discov. 2019 Mar;18(3):175-196. doi: 10.1038/s41573-018-0006-z.

    PubMed 30622344

  • Szeto GL, Finley SD. Integrative Approaches to Cancer Immunotherapy. Trends Cancer. 2019 Jul;5(7):400-410. doi: 10.1016/j.trecan.2019.05.010.

    PubMed 31311655

  • Zhang Y, Zhang Z. The history and advances in cancer immunotherapy: understanding the characteristics of tumor-infiltrating immune cells and their therapeutic implications. Cell Mol Immunol. 2020 Aug;17(8):807-821. doi: 10.1038/s41423-020-0488-6. Epub 2020 Jul 1.

    PubMed 32612154

  • Gao T, Cen Q, Lei H. A review on development of MUC1-based cancer vaccine. Biomed Pharmacother. 2020 Dec;132:110888. doi: 10.1016/j.biopha.2020.110888. Epub 2020 Oct 21.

    PubMed 33113416

  • Nabavinia MS, Gholoobi A, Charbgoo F, Nabavinia M, Ramezani M, Abnous K. Anti-MUC1 aptamer: A potential opportunity for cancer treatment. Med Res Rev. 2017 Nov;37(6):1518-1539. doi: 10.1002/med.21462. Epub 2017 Jul 31.

    PubMed 28759115

  • Hossain MK, Wall KA. Immunological Evaluation of Recent MUC1 Glycopeptide Cancer Vaccines. Vaccines (Basel). 2016 Jul 26;4(3):25. doi: 10.3390/vaccines4030025.

    PubMed 27472370

  • Park JA, Park S, Park HB, Han MK, Lee Y. MUC1-C Contributes to the Maintenance of Human Embryonic Stem Cells and Promotes Somatic Cell Reprogramming. Stem Cells Dev. 2021 Nov 1;30(21):1082-1091. doi: 10.1089/scd.2021.0185. Epub 2021 Oct 18.

    PubMed 34514853

  • Rajabi H, Kufe D. MUC1-C Oncoprotein Integrates a Program of EMT, Epigenetic Reprogramming and Immune Evasion in Human Carcinomas. Biochim Biophys Acta Rev Cancer. 2017 Aug;1868(1):117-122. doi: 10.1016/j.bbcan.2017.03.003. Epub 2017 Mar 14.

    PubMed 28302417

  • Nath S, Mukherjee P. MUC1: a multifaceted oncoprotein with a key role in cancer progression. Trends Mol Med. 2014 Jun;20(6):332-42. doi: 10.1016/j.molmed.2014.02.007. Epub 2014 Mar 22.

    PubMed 24667139

  • Chen W, Zhang Z, Zhang S, Zhu P, Ko JK, Yung KK. MUC1: Structure, Function, and Clinic Application in Epithelial Cancers. Int J Mol Sci. 2021 Jun 18;22(12):6567. doi: 10.3390/ijms22126567.

    PubMed 34207342

  • Macao B, Johansson DG, Hansson GC, Hard T. Autoproteolysis coupled to protein folding in the SEA domain of the membrane-bound MUC1 mucin. Nat Struct Mol Biol. 2006 Jan;13(1):71-6. doi: 10.1038/nsmb1035. Epub 2005 Dec 20.

    PubMed 16369486

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vaccine in people with Solid Tumor, Adult, run by Peking Union Medical College 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 11 inclusion and 20 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 14 Aug 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Fang Li, MD (+86-010-69154417, lifang@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The safety of the vaccine using CTCAE v5.0 based on the number of patients with treatment-related adverse events. (time frame: 8~12weeks). The study lists 3 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 NCT05986981, which also lists 17 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 14 Aug 2023.

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