All Drugs and Chemicals

Vaccines

Enrollment 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).

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).

Vaccine

Fang Li, MD

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.

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.

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.

MUC1 Therapeutic Tumor Vaccine in Advanced Solid Cancers

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

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

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
MUC1 Therapeutic Tumor Vaccine in Advanced Solid Cancers	NCT05986981	Solid Tumor, Ad...	Vaccine	18 Years - 75 Years	Peking Union Medical College Hospital
MUC1 Therapeutic Tumor Vaccine in Advanced Solid Cancers	NCT05986981	Solid Tumor, Ad...	Vaccine	18 Years - 75 Years	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for mucin 1

Every month we try and update this database with for mucin 1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mucin 1

Every month we try and update this database with for mucin 1 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mucin 1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.