Clinical Study of Novel Therapeutic Vaccine for Advanced Solid Tumors

NCT07567222 | Recruiting Phase 1

• 1 other identifier: 2025-2774
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Malignant Tumor

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

  DLT is defined as any Treatment-Related Adverse Event (TRAE) or clinically significant laboratory abnormality occurring during the DLT observation period. TRAEs include events judged by the investigator to be "definitely," "probably," or "possibly" related to the study treatment. Severity will be graded according to NCI-CTCAE v5.0.

  From the first dose up to 14 days following the third dose (Day 0 to approximately Day 42).

• Number of Participants Who Experienced an Adverse Event (AE)

  An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of the product was also an AE. The number of participants who experienced an AE was reported for each arm.

  Up to 6 months from the date of the first dose.

Secondary Outcomes (3)

• Objective Response

  Up to 6 months from the date of the first dose.

• Progression-Free Survival

  Up to 6 months from the date of the first dose.

• Overall Survival

  Up to 12 months from the date of the first dose.

Study Arms (9)

Osteosarcoma: YMN101(Part A1)

EXPERIMENTAL

Participants will receive doses informed by the safety data and tolerability ranges established for analogous candidates in clinical studies. Patients with advanced osteosarcoma will be administered the vaccine via subcutaneous injection, with the immunization regimen consisting of a priming phase and a booster phase. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points per protocol.

Biological: YMN101

Pancreatic cancer: YMN102 (Part B1)

EXPERIMENTAL

Participants were assigned to different dose-level cohorts according to the order of enrollment, following a sequential escalation from low to high doses. Patients with advanced pancreatic cancer were administered the vaccine via subcutaneous injection, with the immunization regimen consisting of a priming phase and a booster phase. Dose escalation followed a standard 3+3 design to evaluate the safety and DLTs at each dose level. Participants received the assigned cell dose during the priming phase and completed subsequent administrations at predefined intervals according to the protocol.

Biological: YMN102

Head and neck squamous cell carcinoma: YMN103 (Part C1)

EXPERIMENTAL

Patients with advanced head and neck squamous cell carcinoma (HNSCC) will be vaccinated via subcutaneous injection. The immunization regimen encompasses a priming phase and subsequent booster phases. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points to evaluate the safety and tolerability.

Biological: YMN103

Colon cancer: YMN104 (Part D1)

EXPERIMENTAL

Patients with advanced colon cancer will be vaccinated via subcutaneous injection. The immunization regimen encompasses a priming phase and subsequent booster phases. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points to evaluate the safety and tolerability.

Biological: YMN104

Hepatocellular carcinoma: YMN105 (Part E1)

EXPERIMENTAL

Patients with advanced hepatocellular carcinoma (HCC) will be vaccinated via subcutaneous injection. The immunization regimen encompasses a priming phase and subsequent booster phases. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points to evaluate the safety and tolerability.

Biological: YMN105

Glioma: YMN106 (Part F1)

EXPERIMENTAL

Participants were assigned to different dose-level cohorts according to the order of enrollment, following a sequential escalation from low to high doses. Patients with advanced glioma received intracalvariosseous (ICO) injection of the vaccine. The immunization regimen consists of a priming phase and a booster phase. Dose escalation follows a standard 3+3 design to evaluate safety and DLTs at each dose level. Participants receive the assigned cell dose via intraosseous administration during the priming phase and complete subsequent administrations at predefined intervals according to the protocol.

Biological: YMN106

Pancreatic cancer: YMN107 (Part G1)

EXPERIMENTAL

Participants were assigned to different dose-level cohorts according to the order of enrollment, following a sequential escalation from low to high doses. Patients with advanced pancreatic cancer were administered the vaccine via subcutaneous injection, with the immunization regimen consisting of a priming phase and a booster phase. Dose escalation followed a standard 3+3 design to evaluate the safety and DLTs at each dose level. Participants received the assigned cell dose during the priming phase and completed subsequent administrations at predefined intervals according to the protocol.

Biological: YMN107

Breast cancer: YMN108 (Part H1)

EXPERIMENTAL

Participants were assigned to different dose-level cohorts according to the order of enrollment, following a sequential escalation from low to high doses. Patients with advanced or recurrent metastatic breast cancer were administered the vaccine via subcutaneous injection, with the immunization regimen consisting of a priming phase and a booster phase. Dose escalation followed a standard 3+3 design to evaluate the safety and DLTs at each dose level. Participants received the assigned cell dose during the priming phase and completed subsequent administrations at predefined intervals according to the protocol.

Biological: YMN108

Osteosarcoma: YMN101(Part A2)

EXPERIMENTAL

Participants will receive doses informed by the safety data and tolerability ranges established for analogous candidates in clinical studies. Patients with advanced osteosarcoma refractory to prior chemotherapy will be administered the vaccine via subcutaneous injection with concomitant regorafenib, following a priming-booster immunization regimen. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points per protocol.

Biological: YMN101; Drug: Regorafenib

Interventions

YMN101 BIOLOGICAL

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.

Osteosarcoma: YMN101(Part A1); Osteosarcoma: YMN101(Part A2)

YMN102 BIOLOGICAL

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.

Pancreatic cancer: YMN102 (Part B1)

YMN103 BIOLOGICAL

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.

Head and neck squamous cell carcinoma: YMN103 (Part C1)

YMN104 BIOLOGICAL

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.

Colon cancer: YMN104 (Part D1)

YMN105 BIOLOGICAL

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.

Hepatocellular carcinoma: YMN105 (Part E1)

YMN106 BIOLOGICAL

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.

Glioma: YMN106 (Part F1)

YMN107 BIOLOGICAL

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.

Pancreatic cancer: YMN107 (Part G1)

YMN108 BIOLOGICAL

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.

Breast cancer: YMN108 (Part H1)

Regorafenib DRUG

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

Osteosarcoma: YMN101(Part A2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed advanced solid tumors, or radiologically diagnosed HCC, eligible for one of the following study parts based on tumor type, clinical status, and prior treatment history:
• Part A1: Patients with advanced osteosarcoma who achieved Stable Disease (SD) or Partial Response (PR) following first-line chemotherapy, and have at least one remaining lung metastatic lesion \>= 0.5 cm.
• Part A2: Patients with advanced osteosarcoma who have relapsed, metastasized, or progressed following prior chemotherapy, or who are intolerant to the toxicities of previous systemic therapy.
• Part B1: Patients with advanced pancreatic cancer and disease progression following \>= 1 prior line of standard systemic therapy.
• Part C1: Patients with advanced HNSCC and disease progression following \>= 2 prior lines of systemic therapy.
• Part D1: Patients with advanced colon cancer and disease progression following \>= 3 prior lines of therapy (including fluoropyrimidine, oxaliplatin, and irinotecan). Patients with RAS wild-type must have received EGFR inhibitors.
• Part E1: Patients with advanced hepatocellular carcinoma (HCC) and disease progression following \>= 2 prior lines of systemic therapy.
• Part F1: Patients with advanced glioma and disease progression following the first-line Stupp regimen.
• Part G1: Patients with advanced pancreatic cancer and disease progression following \>= 1 prior line of therapy.
• Part H1: Patients with advanced or recurrent metastatic breast cancer who have progressed on or after \>= 3 prior lines of systemic therapy.
• Age 18-75 years.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
• Life expectancy \> 3 months.
• Adequate organ function within 7 days prior to first dose, including:
• Hematologic: Hemoglobin (Hb) \>= 80 g/L; White Blood Cell count (WBC) \>= 3.0 x 10\^9/L; Platelet count (PLT) \>= 80 x 10\^9/L; Absolute Neutrophil Count (ANC) \>= 1.5 x 10\^9/L.

You may not qualify if:

• Another primary malignancy within 5 years prior to first dose, except for adequately treated non-melanoma skin cancer, carcinoma in situ, or localized low-risk cancers.
• Active central nervous system (CNS) metastases or leptomeningeal disease.
• Positive for infectious diseases, including HIV, active Hepatitis C (HCV RNA positive), or active Hepatitis B (HBsAg or HBcAb positive with HBV DNA \>= 500 IU/mL or \>= 2000 copies/mL).
• Active pulmonary tuberculosis.
• Active autoimmune disease requiring systemic treatment within the past 2 years; or use of systemic corticosteroids (\> 10 mg/day prednisone equivalent) within 4 weeks prior to first dose.
• Major surgery or significant trauma within 28 days prior to enrollment, or presence of unhealed wounds, ulcers, or conditions associated with high risk of bleeding or perforation.
• Arterial/venous thrombosis or pulmonary embolism within 6 months, or CTCAE Grade \>= 3 bleeding event within 28 days prior to treatment.
• Localized conditions at the injection site (e.g., infection, inflammation, or extensive scarring) or clinically significant coagulation disorders that contraindicate subcutaneous or intraosseous administration.
• Known hypersensitivity or intolerance to study treatment components or related compounds.
• Pregnant or breastfeeding, or planning to conceive (participant or partner) during the study.
• Any condition that, in the investigator's judgment, may compromise safety or interfere with study participation or evaluation.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (2)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

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MeSH Terms

Conditions

Neoplasms

Interventions

regorafenib

Central Study Contacts

Xingchen Peng, Professor

CONTACT

+86 18980606753; pxx2014@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)