Irradiated tumor-and-stroma vaccine for advanced solid tumors

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

This Phase 1 test will try an irradiated vaccine made from tumor cells and nearby stromal cells, with or without GM-CSF, to see if it is safe and can stimulate the immune system in people with advanced solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 2 sites (Chengdu, Sichuan and 1 other locations)
• Trial ID: NCT07567222 on ClinicalTrials.gov

What this trial studies

This first-in-human Phase 1 trial administers a whole-cell vaccine composed of irradiated tumor cells combined with stromal cells and an adjuvant, with some vaccine variants transfected to express GM-CSF. The vaccine is given to patients with various advanced solid tumors in separate parts defined by tumor type and prior treatments. Primary goals are to determine safety and tolerability and to gather early immune-response and dose information. The program builds on preclinical models showing antitumor activity with limited toxicity but has not yet demonstrated clinical efficacy in humans.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically or cytologically confirmed advanced solid tumors meeting specific part criteria (e.g., osteosarcoma with residual lung metastasis after first-line chemo or relapsed/progressed osteosarcoma, pancreatic cancer after ≥1 prior systemic therapy, HNSCC after ≥2 prior lines, colon cancer after ≥3 prior lines, or radiologically diagnosed HCC) and who meet performance and safety requirements.

Not a fit: Patients with early-stage disease, those who do not meet the protocol-defined tumor-type or prior-treatment criteria, or those too frail or medically ineligible for an experimental immunotherapy are unlikely to benefit from this Phase 1 safety trial.

Why it matters

Potential benefit: If successful, the vaccine could broaden antitumor immune responses and potentially slow disease progression in patients with advanced solid tumors.

How similar studies have performed: Preclinical studies across multiple tumor models reported potent antitumor activity without significant toxicity, but this is a first-in-human trial and clinical benefit remains unproven.

Eligibility criteria

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 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.
2. Age 18-75 years.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
4. Life expectancy \> 3 months.
5. 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.

   Hepatic: Total bilirubin \<= 1.5 x ULN (\<= 3 x ULN for liver metastases or HCC); ALT and AST \<= 2.5 x ULN (\<= 5 x ULN for liver metastases or HCC).

   Renal: Creatinine clearance \> 60 mL/min (Cockcroft-Gault formula). Coagulation: International Normalized Ratio (INR) \<= 1.5 x ULN.
6. At least one measurable or evaluable lesion per RECIST v1.1.
7. Ability to understand and sign written informed consent and comply with study procedures.

Exclusion Criteria

1. 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.
2. Active central nervous system (CNS) metastases or leptomeningeal disease.
3. 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).
4. Active pulmonary tuberculosis.
5. 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.
6. 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.
7. Arterial/venous thrombosis or pulmonary embolism within 6 months, or CTCAE Grade \>= 3 bleeding event within 28 days prior to treatment.
8. Localized conditions at the injection site (e.g., infection, inflammation, or extensive scarring) or clinically significant coagulation disorders that contraindicate subcutaneous or intraosseous administration.
9. Known hypersensitivity or intolerance to study treatment components or related compounds.
10. Pregnant or breastfeeding, or planning to conceive (participant or partner) during the study.
11. Any condition that, in the investigator's judgment, may compromise safety or interfere with study participation or evaluation.

Where this trial is running

Chengdu, Sichuan and 1 other locations

• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Xingchen Peng, Professor

Conditions Malignant Tumor