Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07567222 | Clinical Study of Novel Therapeutic Vaccine for Advanced Solid Tumors | PHASE1 | RECRUITING | 54 | — | — | May 15, 2026 | Jun 30, 2027 | May 6, 2026 | 2 | China |
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Regorafenib | DRUG | Regorafenib at 160 mg once daily from Day 1 to Day 21, every 4 weeks (Q4W). |
Inclusion Criteria 1. 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 Stab...