RecruitingPhase 1NCT07567222

Clinical Study of Novel Therapeutic Vaccine for Advanced Solid Tumors

Safety, Tolerability, and Preliminary Antitumor Activity of Novel Therapeutic Tumor Vaccines in Advanced Solid Tumors

Sponsor

West China Hospital

Enrollment

54 participants

Start Date

Jun 5, 2026

Study Type

INTERVENTIONAL

Conditions

Malignant Tumor

Summary

Advanced solid tumors remain a major therapeutic challenge due to their complex heterogeneity and the immunosuppressive tumor microenvironment (TME). Although cancer vaccines are designed to induce long-lasting antitumor immunity, their efficacy is often limited by the TME's immune-evasive mechanisms. Building on this rationale, investigators developed a novel vaccine comprising irradiated tumor cells and stromal cells isolated from adjacent non-cancerous tissues or tumor tissues in combination with adjuvant. Irradiated tumor cells in vaccines such as YMN102, YMN103, YMN104, YMN105, YMN106, and YMN107 are transfected with GM-CSF; the others, such as YMN101 and YMN108, are not transfected with GM-CSF. Preclinical studies across multiple tumor models have demonstrated potent antitumor activity with no significant toxicity observed following administration. This first-in-human Phase I study is designed to evaluate the safety and tolerability of this irradiated vaccine in patients with advanced solid tumors, alongside a preliminary assessment of its antitumor activity and immunogenic profile. This is a first-in-human, Phase I, open-label study designed to evaluate the safety and tolerability of this novel vaccine. The study includes multiple arms targeting specific malignancies, including osteosarcoma, pancreatic cancer, HNSCC, colorectal cancer, HCC, glioma, and TNBC. The primary objective is to determine the incidence of dose-limiting toxicities (DLTs). Secondary objectives include assessing the objective response, progression-free survival (PFS), and overall survival (OS) per RECIST v1.1. Exploratory analyses will monitor dynamic changes in circulating biomarkers and intratumoral immune modulation to identify potential predictive markers of clinical response.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Regorafenib, a biological treatment called YMN101, and others for people with malignant tumor. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALYMN101

In the priming phase, subjects receive subcutaneous injections of the YMN101 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.

BIOLOGICALYMN102

In the priming phase, subjects receive subcutaneous injections of the YMN102 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.

BIOLOGICALYMN103

In the priming phase, subjects receive subcutaneous injections of the YMN103 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.

BIOLOGICALYMN104

In the priming phase, subjects receive subcutaneous injections of the YMN104 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.

BIOLOGICALYMN105

In the priming phase, subjects receive subcutaneous injections of the YMN105 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.

BIOLOGICALYMN106

In the priming phase, subjects receive intracalvariosseous (ICO) injection of the YMN106 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.

BIOLOGICALYMN107

In the priming phase, subjects receive subcutaneous injections of the YMN107 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.

BIOLOGICALYMN108

In the priming phase, subjects receive subcutaneous injections of the YMN108 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.

DRUGRegorafenib

Regorafenib at 160 mg once daily from Day 1 to Day 21, every 4 weeks (Q4W).